Clinical Trials
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Gerontology/Geriatrics
Bone Healing in Healthy and Post-menopausal Osteoporotic Women
Mar 2013Both the pathogenesis and the treatment of osteoporosis may potentially interfere at different levels on the multi-stage complex cascade of events involved in bone healing/regeneration. To our knowledge no human studies have been performed to clarify the potential effect of osteoporosis on post-extraction alveolar healing. The primary outcome of the study is to compare alveolar bone changes in width and height 3 months after tooth extraction in 15 post-menopausal osteoporotic women and 15 healthy pre or post menopausal women by the use of cone-beam computer tomography (CBCT) images. As secondary outcome the investigators put: changes in the external contour of the ridge together with periodontal parameters in the neighbouring teeth, tissue blood perfusion changes during the initial healing (assessed by laser doppler flowmetry) and levels of serum bone resorption/formation markers.
Sensory Support Care for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease (SensiCare)
Mar 2013The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.
Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients
Mar 2013Many decisions involve the possibility of gaining or losing relative to the status quo. The loss aversion behaviour is a cognitive concept explaining that people are more sensitive to the possibility of losing objects or money than they are to the possibility of gaining the same objects or amounts of money. We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money. The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.
Sub-thalamic Nucleus Stimulation in Parkinson Disease (PARKEO)
Mar 2013Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology. This study is a prospective, randomized and monocentric study to compare two DBS procedures with or without electrophysiology. A better control of targeting and trajectory is necessary before not using electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei without the need of electrophysiology. Two groups of patients will be followed: a first group of patients with a procedure under general anesthesia alone without electrophysiological stimulation and a second smaller group of patients with a first step of electrode implantation under awake surgery with electrophysiological stimulation followed by a second step under general anesthesia for the implantation of stimulator. Clinical results will be assessed at 6 months after implantation.
Early Diagnosis of Alzheimer-like Dementia: Benefit of MRI and PET Imaging
Mar 2013The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. Early detection of the disease is a major challenge to hope to slow or even stop the neurodegenerative process before the stage of dementia. In AD the investigators observe: A reduction in the volume of brain hippocampi associated with an alteration of the diffusion of water molecules in the white matter. A structural brain degeneration coupled with a decrease in cerebral glucose metabolism. Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that aim,the investigators use two imaging modalities: Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain Positron emission tomography (PET) is used to assess glucose metabolism in grey/white matter and also in choroid plexus. The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be altered as well as glucose metabolism dynamic in choroid plexus.
Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy (GONDOPARK)
Mar 2013The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.
A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Mar 2013The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001
A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients ≥ 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy.
Feb 2013To investigate the efficacy, of intravenous volasertib + subcutaneous low-dose cytarabine in patients ≥ 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy. Efficacy will be determined primarily based on remission rate (CR+CRi) and overall survival (OS).
Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life (THERAD)
Feb 2013Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.
EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PD (EEGDBSNAd)
Feb 2013Deep brain stimulation (DBS) of the subthalamic nucleus (STN) remarkably improves motor functions in patients with Parkinson disease (PD). However, growing evidence suggests that STN-DBS also causes executive inhibitory deficits and impulsive behaviour (Jahanshahi et al 2000; Schroeder et al 2002; Hershey et al 2004; Thobois et al 2007; Frank et al 2007; Ballanger et al., 2009). Despite a widespread use, the mechanisms of action of STN-DBS are still unclear. Two reasons might explain this. 1) From a theoretical point of view, cognitive models of executive control mechanisms are incomplete. 2) From a methodological point of view, investigating cerebral activity during STN-DBS is very limited because most techniques are incompatible with locally implanted electrodes. This project relies on a double opportunity to answer these questions offered by recent theoretical and methodological advances. First, investigations in healthy subjects (Jaffard et al 2007, 2008, Boulinguez et al 2009) revealed an essential function of inhibitory control, so far ignored, consisting in locking in advance movement triggering processes to prevent undesired automatic or anticipated responses to unattended stimuli. In other words, key processes of executive control may act tonically before stimulation occurs, calling brain imaging studies to look at proactive and not only reactive activations. Second, recent advances in EEG signal processing now allow suppressing from the electroencephalogram DBS-related artifacts (Allen et al. 2010), providing a tremendous opportunity to use a non-invasive technique with the high temporal resolution necessary to disentangle proactive from reactive brain activity. To our knowledge, up to date no study has been published using EEG with STN-DBS patients since Allen et al.'s paper. The first operational purpose of this project is to identify the anatomo-functional origin of STN-DBS-induced executive dysfunction using EEG recordings in classical stimulus-response tasks. Results expected from this first part of the project may help resolving other long-lasting issues. Indeed, reactivity as assessed by simple reaction time in non-implanted patients as well as impulsivity in STN-DBS patients are known to remain insensitive to dopaminergic medication. Since the proactive activity related to executive, inhibitory, control may be supported by the noradrenergic (NA) system, the second purpose of this project is to test the original hypothesis according to which NA plays a central role in both akinesia and STN-DBS side effects.
Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
Feb 2013The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods
Gut-derived Neuropeptides in Cerebrospinal Fluid of Patients With Parkinson's Disease and Healthy Controls
Feb 2013Collection of CSF and serum samples in a standardized way in order to quantitatively measure the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions: Do CSF (and serum) concentrations of these gut peptides differ between PD patients and controls? Do CSF (and serum) concentrations of the investigated peptides correlate with clinical and / or epidemiological characteristics of the investigated subjects (age, gender, BMI, disease duration, severity of motor impairments, presence of non-motor symptoms, co-morbidities, medication, etc.)?
RCT: Added Value of Coordinator for the Management of Hip Fracture Patients
Feb 2013To evaluate whether a coordinator increases the optimal management of osteoporotic fracture patients and hip fracture patients.
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb (PREVOST)
Jan 2013The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old. This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.
Standard Clopidogrel Versus Prasugrel Low Dose Therapy in Elderly Patients With Acute Coronary Syndrome (RESET ELDERLY)
Jan 2013The elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. The present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in PR response of the latter should allows the Prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with Clopidogrel.
Central and Systemic Inflammation in Alzheimer's Disease (IMABio3)
Jan 2013The main objective of this study is to investigate the central and peripheral inflammatory, as well as the spontaneous Aβ-specific, immune responses at the asymptomatic stage and early stages of AD by combining molecular imaging techniques with blood biomarker analyses. The early and preclinical stages of AD will be studied in the relatives of patients with PSEN1, PSEN2 or APP mutations that are at-risk (50%) to be mutation carriers. This study will evaluate the contribution of Inflammatory and immune anti-Aβ responses (I2ARs) in AD progression. Inclusion of sporadic and familial forms of AD will aid in studying the chronology of pathological events. Clinical follow-ups will be conducted annually for two years and will include an MRI and a blood draw on the last visit. We expect I2ARs to appear in the early stages of the disease and to constitute new prognostic factors. I2ARs could also become therapeutic markers for the assessment of novel anti-amyloid treatments and may offer new insights to the development of Aβ-specific immunotherapy strategies.
A Randomised, Placebo-Controlled, Parellel-Group, Double-Blind Efficacy and Safety Trial of MK-8931 in Subjects with Mild to Moderate Alzheimer's Disease
Jan 2013To assess the efficacy of two doses of MK-8931 on cognition in sugjects with mild to moderate AD To assess the efficacy of two doses of MK8931 on functional ability in activities of daily living in subjects with mild to moderate AD To assess the safety and tolerability of threee doses of MK-8931 in the treatment of subjects with mild to moderate AD
Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
Jan 2013This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
Cytochrome P450-2D6 Screening Among Elderly Using Antidepressants (CYSCE)
Jan 2013Depression is common among elderly with an estimated prevalence of 5%. Due to ageing the national burden will double in the coming decade. Antidepressants as TCAs and SSRIs are effective in reducing symptoms, especially in people with severe depression. To optimize treatment efficacy and reduce side effects, the Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association developed guidelines for dose-adaptation, for instance for antidepressants such as nortriptyline and venlafaxine based on their main relevant genotype (CYP2D6) accompanied by Therapeutic Drug Monitoring. Such personalized drug dosing based on pharmacogenetic information at the start of therapy can speed up the titration phase of antidepressants to establish an adequate maintenance dose. However, pharmacogenetic screening programs are expensive and evidence on effects and costs of such a program among elderly antidepressant starters from randomized controlled studies is lacking. The investigators will conduct a pragmatic randomized controlled trial to determine the effects and costs of pharmacogenetic screening information to optimize drug dosing in depressed elderly patients who start with nortriptyline or venlafaxine. Objective: The primary objective is to determine the effects of pharmacogenetic screening for CYP2D6 on the time to reach adequate blood levels as an accepted proxy for adequate treatment. Secondary objectives include adverse drug reactions and cost-effectiveness
Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area
Jan 2013Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area. The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).
Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients
Jan 2013The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money. The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.
Displaced Femoral Neck Fracture in Elderly Patient. Should Cement be Used for Hip Hemiarthroplasty ? (PIH)
Jan 2013The purpose of this study was to identify the clinical relevance of cementless hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the relevance of cementless hemiarthroplasties in displaced femoral neck fractures.
A randomized, controlled, parallel group, double-blind, multi-centre, phase IIb study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations of patients who participated in the AFFITOPE® AD02 phase II study AFF006.
Jan 2013To assess the longterm safety and tolerability of continued AFFITOPE® AD02 administrations following a predefined vaccination schedule (boosts at regular intervals after priming) over a total period of 37 months (includes the 18 months of the preceding AFF006 study). To assess the clinical activity (parameters for cognition and function) of vaccination with AFFITOPE® AD02 when extending the vaccination schedule applied within the preceding phase II study AFF006 by boosts at regular intervals (comparison to previous placebo patients now being vaccinated with verum).
Prevention of depression and poor physical function in older persons with vitamin D supplementation
Jan 2013The primary objective of the D-Vitaal trial is to answer the following two questions: 1. Does vitamin D supplementation decrease depressive symptoms in older persons? 2. Does vitamin D supplementation improve physical performance and decrease functional limitations in older persons?
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
Jan 2013Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
Jan 2013Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood
Nov 2012To assess the effects of rotigotine over placebo on improvement of apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson?s disease
A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease.
Nov 2012This is a feasibility study designed to inform the following process / primary outcomes: • to obtain estimates of memory performance which will inform a power calculation; • to explore with patient-participants and carers barriers to participation which include management of symptoms during washout period. This will be achieved formally using the end of study focus group as well as informally during mid-and end of study clinic visits with clinical members of research team, and during ON/OFF research visits with the PhD student/assessor.
Simvastatin as adjuvant therapy to correct neutrophil dysfunction in older pneumonia patients - a randomised double blind placebo controlled trial
Nov 2012Pneumonia (severe lung infection) is one of the commonest causes of death and the death rate has not fallen for many years. Elderly patients are at greater risk of pneumonia and its complications such as sepsis. Usually the immune system works cooperatively to clear infection and prevent organ damage. Neutrophils are cells of the immune system that are critical in clearing bacteria. These cells are the foot soldiers of the immune system and move from the blood into infected tissues/organs to locate and kill the invading bacteria using an arsenal of toxic products. Sepsis occurs when the bodies normally helpful reaction to infection becomes harmful. As part of this process, neutrophils stop working properly, they become less able to clear bacteria and release their toxic products indiscriminately, causing organ damage. Defects in the efficiency of these cells is associated with a poor outcome from pneumonia and sepsis.
A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
Nov 2012The primary objective of this study is to evaluate if the effect of administering denosumab (60 mg subcutaneously [SC] every 6 months [Q6M]) is not inferior to that of zoledronic acid (5 mg intravenously [IV] once yearly) in postmenopausal women with osteoporosis previously treated with oral bisphosphonates with respect to change in bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months.
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
Nov 2012This study will compare the effectiveness of Denosumab treatment Q6M with once yearly Zoledronic Acid treatment on Bone Mineral Density (BMD) at various skeletal sites.
A European multicenre double-blind placebo controlled phase III trial of nilvadipine in mild to moderate Alzheimer's disease.
Nov 2012To investigate the efficacy of Nilvadipine as a disease course modifying treatment for mild to moderate AD in a phase III double-blind placebo-controlled study. To investigate the safety profile of Nilvadipine in patients with mild to moderate AD.
A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
Nov 2012To assess the effects of Rotigotine over placebo on improvement of Parkinson’s disease associated chronic pain in subjects with advanced-stage Parkinson’s disease experiencing Parkinson’s disease associated chronic pain.
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild Alzheimer’s Disease
Nov 20121. To demonstrate the clinical efficacy of leuco-methylthioninium bis(hydromethanesulfonate) (also known as LMTM, TRx0237) in mild Alzheimer’s disease as assessed by change from baseline on: • Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog11) • Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC) - independently rated 2. To evaluate the effect of LMTM on Alzheimer’s disease modification as evidenced by reduction in decline in glucose uptake in the temporal lobe on 18F-flurodeoxyglucose positron emission tomography (FDG-PET) / computerized tomography (CT) imaging 3. To assess the safety and tolerability of LMTM 200 mg/day given for up to 78 weeks
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Month Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild to Moderate Alzheimer's Disease
Nov 20121. To demonstrate the clinical efficacy of at least one dose level of TRx0237 in mild to moderate Alzheimer’s disease as assessed by change from baseline on: • Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-cog11) • Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC) - independently rated 2. To determine the safety and tolerability of TRx0237 150 and 250 mg/day
VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)
Oct 2012The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
Randomized, double-blind, placebo-controlled trial to compare the effect, three months of follow-on pulse pressure and vascular function of isosorbide mononitrate extended release, associated with antihypertensive treatment in patients over 65 years refractory isolated systolic hypertension
Sep 2012To compare the effect on clinic pulse pressure of extended release isosorbide mononitrate vs placebo, added to the usual treatment of patients over 65 with refractory ISH, after 3 months of treatment.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT 126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Sep 2012The objective of this study is to evaluate the efficacy and safety of two doses of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of AChEIs
A multicenter, open-label, long-term safety extension of phase II studies ABE4869G and ABE4955G in patients with mild to moderate alzheimer’s disease
Sep 2012To assess the long-term safety and tolerability of crenezumab administered subcutaneously (SC) every 2 weeks (q2w) or intravenously (IV) every 4 weeks (q4w), in eligible patients with Alzheimer’s disease who participated in Study ABE4869g or ABE4955g and completed the Week 73 study visit, including brain MRI.
An Extension Study to Evaluate Six Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003
Sep 2012• Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. • Provide information on the vertebral fracture rate in subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. • Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo.
Observational Study of Prolia® in Postmenopausal Women With Osteoporosis
Aug 2012The study is being performed to describe Prolia® patients' medication-taking behavior in a non-interventional routine clinical care setting
FDDNP-PET for in vivo diagnosis of Tauopathy in unclassifiable parkinsonism
Aug 2012To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of [18F]-FDDNP
Teriparatide and Risedronate in the Treatment of Patients with Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
Jul 2012The primary objective of this study is to evaluate if teriparatide 20 μg subcutaneously once daily is superior in reducing the incidence of new vertebral fractures during 24 months of therapy, when compared with risedronate 35 mg orally once weekly, in postmenopausal women with prevalent vertebral fragility fractures.
efficacy of rotigotine on gait performance of parkinsonian patients
Jul 2012Patients suffering for Idiopathic Parkinson’s Disease. H&Y stage > or = 2 with un-satisfactory control by on-going pharmacological therapy (Levodopa, COMT & MAO-inhibitors), characterised by an incomplete control of motor signs, in particular presence of early morning akinesia, as well as gait deficits in the morning.
Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo, in co-administration with donepezil (10 mg/day) in patients with moderate Alzheimer’s Disease. A 24-week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study.
Jul 2012To assess the efficacy of 3 fixed doses of S 38093 (2, 5 and 20mg/ day) versus placebo, in co-administration with donepezil 10 mg/day, after 24 weeks of treatment, on cognitive performance measured with the ADAS-Cog 11-items in patients with moderate Alzheimers' Disease
A randomised phase 2 trial investigating the additional benefit of hydroxychloroquine(HCQ) to short course radiotherapy (SCRT) in patients aged 70 years and older with high grade gliomas (HGG)
Jul 2012To examine the effect on one year survival of giving hydroxychloroquine (HCQ) with short course radiotherapy (SCRT) to high grade gliomas (HGG) patients aged ≥ 70 years
A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of LMTM in Subjects with Mild to Moderate Alzheimer’s Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy
Jun 2012To assess the safety and tolerability of leuco-methylthioninium bis(hydromethanesulfonate) (LMTM) 250 mg daily when co-administered with an acetylcholinesterase inhibitor (AChEI) and/or memantine to patients with mild to moderate Alzheimer’s disease. As exploratory objectives, markers of monoamine oxidase (MAO) inhibition will be assessed and blood samples collected for separate population pharmacokinetic analysis.
Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer's Disease
Jun 2012The primary objective of this study is to assess the CSF PD effect of different LY2886721 doses in patients with MCI due to AD or mild AD compared to placebo, measured by change of CSF Aβ1-40 and Aβ1-42 concentrations from baseline to Week 12 and Week 26.
Long-Term Safety and Tolerability of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793
Jun 2012Evaluate the long-term safety and tolerability of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of AChEIs in a 28-week open-label extension of Study M11-793.
Study of a National Cohort of Adult Patients With Phenylketonuria (ECOPHEN)
Jun 2012Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in France, because it is treatable by a diet low in phenylalanine. This plan is required upon confirmation of diagnosis and continued until the age of 8 years. The current trend is to continue the scheme at least until adolescence. Unlike other countries, in France there are no recommendations for a plan "for life". Knowledge about the natural history of PKU in adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic factors are poorly documented. On the other hand, there is no consensus on the therapeutic management of this disease in adulthood and monitoring that could be directed towards the detection of neurological disorders and nutrition. Social integration and quality of life of adults PKU patients living in France have not been studied.
OsseoScrew Versus Fenestrated Pedicle Screws Augmented With Polymethylmethacrylate (EVOLVE)
May 2012This is an Open-label, prospective, randomized, multi-center post-market study.
A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis
May 2012For the overall study period (12-month double-blind alendronate [ALN]-controlled study period followed by the open-label ALN study period) • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) in women with PMO • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of new vertebral fracture in women with PMO
Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis
May 2012The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis
A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease
May 2012To evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured by [11C]PBR28 binding to TSPO.
Long-Term Safety and Tolerability of ABT-126 in Subjects with Mild-to-Moderate Alzheimer’s Disease: An Open-Label Extension Study for Subjects Completing Study M10-985.
May 2012The objective of this study is to evaluate the long-term safety and tolerability of ABT-126 in subjects with mild-to-moderate AD in a 28-week, open-label extension of Study M10-985.
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD® Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2012-2013, when Administered to Elderly Subjects
May 2012Safety Objectives: To evaluate the safety of a single intramuscular (IM) injection of Fluad in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96). Immunogenicity Objectives: Primary To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at approximately 21 days post-immunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes (Note for Guidance on Harmonization of Requirements for Influenza Vaccines CPMP/BWP/214/96: 12 March 1997).
A randomised, double blind, placebo controlled trial to evaluate the effect of Rivastigmine on gait in people with Parkinson’s disease who have fallen.
May 2012This study seeks to assess the benefit of rivastigmine (a drug which augments mental function) on gait (walking) dysfunction in patients with Parkinson’s disease (PD) with a past history of a fall. The primary aim is to determine the effect of the cholinesterase inhibitor (ChEi) rivastigmine on step time variability in patients with PD. Step time variability is a marker of how stable an individual's walking is and a prognostic marker for future falls risk.
A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease
May 2012To assess the effect of q2 weekly intermittent bilateral intraputamenal GDNF infusions on OFF-state motor function at 9 months.
Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort (ARTEOS2)
Apr 2012The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.
Treatment of osteopenia with melatonin: Effects on BMD, muscle strength and quality of life
Apr 2012The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.
Response-Adapted Sequential Azacitidine And Chemotherapy in Patients > 60 Years Old With Newly Diagnosed AML Eligible for Chemotherapy and allogeneic hematopoietic cell transplantation: A Multicentre Phase I/II study of the East German Hematology and Oncology Study Group (OSHO)
Apr 2012The objective of the trial is to assess efficacy and safety of induction therapy with response-adapted sequential azacitidine and conventional AML induction chemotherapy in patients > 60 years with newly diagnosed AML (at the dose level resulting from the dose evaluation phase of the trial).
A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying
Apr 2012To measure the effect of co-administration of GSK962040 on levodopa pharmacokinetic exposure in subjects with Parkinson’s disease with delayed gastric emptying
A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
Apr 2012The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg subcutaneously (SC) every 6 months (Q6M) is not inferior to treatment with oral risedronate 5 mg every day (QD) with respect to the percent change from baseline in lumbar spine bone mineral density (BMD) by dual X-ray absorptiometry (DXA) at 12 months. The primary objective in the glucocorticoid-initiating subpopulation of men and women treated with glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg SC Q6M is not inferior to treatment with oral risedronate 5 mg QD with respect to the percent change from baseline in lumbar spine BMD by DXA at 12 months.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT 126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Mar 2012The objective of this study is to evaluate the efficacy and safety of two doses of ABT-126 in subjects with mild-to-moderate Alzheimer's disease (AD) taking doses of AChEIs.
Efficacy and safety of delta-9-tetrahydrocannabinol (delta-THC) in pain and pain related behavioural disturbances in dementia
Mar 2012The primary objective is to evaluate the efficacy of Namisol® on pain related behavioural disturbances, such as agitation, aggression and aberrant motor disturbances in patients with dementia, when added to an analgesic treatment with acetaminophen.
A Multicenter, International, Randomized, Double-blind, Placebo controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women With Osteoporosis
Mar 2012To assess the effect of AMG 785 treatment for 12 months compared with placebo on the subject incidence of new vertebral fracture
The Parkinson's Progression Markers Initiative (PPMI)
Mar 2012To identify clinical, imaging and biologic markers pf Parkinson Disease (PD) progression for use in clinical trials of disease-modifying therapies.
Rationalisation of antipsychotic drug use in older people, using [18F]-Fallypride PET
Feb 2012(i)To investigate differences in regional dopamine D2/3 receptor occupancy between Alzheimer's Disease, Schizophrenia Like Psychosis and Healthy Controls after 4 days treatment with amisulpride 50mg daily (ii)To investigate differences in the threshold of dopamine D2/3 receptor occupancy required for 25% symptom reduction and emergence of motor side effects in SLP and AD during 4-10 weeks treatment with amisulpride (50-200mg daily) (iii) To determine dose-response relationships (dose/plasma level/clinical outcome) in SLP and AD during dose-titration of amisulpride (50-200mg) over 4-10 weeks
An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias
Feb 2012To evaluate the long-term safety and tolerability of AFQ056 in patients with PD-LID as assessed by •Incidence and severity of adverse events and serious adverse events •Changes in vital signs, laboratory assessments, and ECGs •Changes in underlying symptoms of PD as measured by the UPDRS (Unified Parkinson’s Disease Rating Scale) part III (Motor Examination) and AEs potentially related to an exacerbation of the movement disorder of PD
13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease
Feb 2012To assess how titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo affects the tolerability profile in patients with moderate to severe PD-LID. To demonstrate the anti-dyskinetic efficacy, as measured by change from baseline to Week 12 in the modified AIMS (Abnormal Involuntary Movement Scale) total score, of titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo in patients with moderate to severe PD-LID.
13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease
Feb 2012To assess how titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo affects the tolerability profile in patients with moderate to severe PD-LID. To demonstrate the anti-dyskinetic efficacy, as measured by change from baseline to Week 12 in the modified AIMS (Abnormal Involuntary Movement Scale) total score, of titration of modified release AFQ056 at 2-week intervals to a target dose of 200 mg b.i.d. or 150 mg b.i.d. versus placebo in patients with moderate to severe PD-LID.
An open-label study to compare the prognostic value of (18F)Flutemetamol PET-imaging with longitudinal biomarker data in healthy volunteers and patients with mild cognitive impairment
Jan 2012To examine the efficacy of raised [18F]Flutemetamol brain uptake for differentiating subjects with mild cognitive impairment (MCI), who subsequently will develop Alzheimer’s disease (AD), from patients with MCI who will be cognitively stable or develop other dementias than AD
A double-blind, placebo-controlled, randomized, multicenter phase II trial to assess the efficacy of temsirolimus added to standard primary therapy in elderly patients with newly diagnosed AML
Jan 2012To compare the median Event Free Survival (EFS)* and the EFS probability of all AML patients between the temsirolimus and the control group * EFS defined as: Time interval from day 1 of study treatment until treatment failure, relapse from CR or CRi, or death from any cause, whichever occurs first. The time point at which the patient is resistant to therapy or survives induction without a CR, CRi or morphologic leukemia-free state will be recorded.
The ACER-study - the effects of galantamine on the variability and stability of walking among patients with Alzheimer's disease.
Jan 2012The main objective of the present study is to examine the effects of treatment with galantamine among patients with AD on the variability and stability of walking (with and without dual-task), functional mobility, standing balance, and cognitive functions (e.g. attention and executive functions).
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy (BILANZ)
Jan 2012The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo.
Jan 2012To study the efficay of gabapentin versus placebo in the disorder of impulse control in the Parkinson´s disease, using for its evaluation the Questionnaire for Impulsive-Compulsive Disorder in Parkinson´s Disease.
A Blinded Extension to 5 Years of a Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium
Dec 20111) To assess the effect of treatment up to 5 years with odanacatib on the risk of morphometrically assessed vertebral fractures compared to placebo. 2) To assess safety and tolerability of treatment up to 5 years with odanacatib 50 mg once weekly compared to placebo.
Multicentre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated with Parkinson's Disease (MUSTARDD-PD)
Dec 2011Is the cholinesterase inhibitor drug donepezil hydrochloride superior to placebo in improving cognitive function, neuropsychiatric burden and functional ability in people with Parkinson’s disease and mild dementia after 24 months of treatment?
A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease
Dec 2011To evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured by [11C]PBR28 binding to TSPO.
Multicentre, randomized, open-label, two-arm parallel groups, active controlled study design to demonstrate efficacy and tolerability of clodronate 200 mg/4 ml solution for intramuscular use with 1% lidocaine every other week vs clodronate 100 mg/3,3ml solution for intramuscular use with 1% lidocaine once-week in a 1-year treatment period of women with postmenopausal osteoporosis
Nov 2011To demonstrate that disodium clodronate 200 mg/4 ml solution for i.m. use with 1% lidocaine administered every other week is not-inferior to disodium clodronate 100 mg/3,3 ml for i.m. use with 1% lidocaine administered once-week in terms of lumbar Bone Mineral Density (BMD).
A Randomized, Double-Blind, Placebo- and Active-Controlled Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects with Mild to Moderate Alzheimer's Disease
Oct 2011Evaluate the dose-response relationship with respect to the efficacy of symptomatic treatment and safety of three doses of ABT-126 in subjects with mild to moderate AD. The primary efficacy measure is the Alzheimer's Disease Assessment Scale – cognitive subscale (ADAS-Cog)
A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain
Sep 2011To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed by averaged 24 hour pain scores collected for 7 days prior to the clinic visits.
Comparison of the effect of an ongoing treatment with alendronate or a drug holiday on the fracture risk in osteoporotic patients with a bisphosphonate long term therapy
Sep 2011Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
Study of Parenterally Administrated Adjuvanted Seasonal Influenza Vaccine in Healthy Elderly Volunteers
Aug 2011The safety of parenterally administrated investigational vaccine (commercial influenza vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly (age 65-75), will be investigated in the study. Moreover, the study aims to study parameters associated with improved protection against clinical disease in elderly. Such parameters include HI-titres, a balanced Th1/Th2 response as well as a functional cellular immune response.
A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease
Aug 2011To assess whether 6 month treatment with Deferiprone is well tolerated by PD patients and assess whether such treatment removes excess iron in the brain area affected in PD, the substantia nigra, as assessed by MRI.
Influenza vaccination in old age: Immunological and biogerontological characterization of responders and non-responders
Aug 2011This study will analyze cellular and humoral immune responses after seasonal vaccination against influenza. Healthy adults are vaccinated with a licensed trivalent inactivated vaccine without adjuvant. The vaccine is licensed for all age groups studied in this study.
A 24 months, prospective, randomized, double-blind study to assess the effect of daily oral administration of 2 g of strontium ranelate versus placebo on bone mineral density in postmenopausal osteoporotic women previously treated with oral bisphosphonates
Aug 2011To demonstrate the effect of strontium ranelate versus placebo of treatment on the areal bone mineral density (BMD) of the lumbar spine in postmenopausal women with osteoporosis previously treated with oral bisphosphonates.
Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer’s disease. A 24- week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study followed by a 24-week extension period
Jul 2011Main objective of the trial to assess the efficacy of S 38093 versus placebo after 24 weeks of treatment, on cognitive performance measured with the ADAS-Cog 11-items in patients with mild to moderate Alzheimer's disease.
Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
Jun 2011The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years.
Neurodegenerative Changes in Alzheimer’s Disease: Identifying potential effects of Victoza® on degenerative changes
Jun 2011To examine the effect of a 6 month treatment course with Victoza, a GLP-1 receptor agonist, on intracerebral amyloid aggregations determined by Pittsburgh Compound B PET-scans.
Collaborative Care for Older Adults With Back Pain (COCOA)
Jun 2011The purpose of the Collaborative Care for Older Adults with Back Pain (COCOA) Clinical Trial is to evaluate the clinical effectiveness and feasibility of a collaborative care model (medical and chiropractic care) through a pragmatic, prospective pilot trial conducted with 120 older adults over the age of 65 with low back pain of at least 1 month duration.
A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias
May 2011To assess the anti-dyskinetic efficacy of multiple doses of AQW051 in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias using the modified Abnormal Involuntary Movement Scale (mAIMS). To assess the anti-parkinsonian effect of multiple doses of AQW051 in combination with L-dopa in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias using the Unified Parkinson’s Disease Rating Scale (UPDRS) – part III. To assess the safety and tolerability of multiple doses of AQW051 in combination with Ldopa in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias.
Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
May 2011For many, Alzheimer's disease is the number one medical issue facing our aging society. It is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and cognitive performance. There are no known treatments that can either prevent or reverse its progression. Consequently, there still remains a need to evaluate treatments which can better stabilize the symptoms of this disease. These symptoms frequently include decreased functional capacity and negative psychological attributes (e,g, depression, anxiety) in association with the memory and cognition deficits. This current study is being done to assess an investigational compound that has been designed to not only improved the cognitive status of affected patients but to also better manage all symptoms. Hence, the ultimate goal is to provide patients with an improved quality of life by slowing the progression of this neurodegenerative disease
Rasagiline treatment for Sleep disorders in Parkinson´s disease
Apr 2011Reduction of sleep disturbances
A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD)
Apr 2011To demonstrate that transdermal nicotine treatment retards disease progression as measured by change in total (part I, II, III) UPDRS score between baseline and after 52 weeks of study treatment plus two more months wash out (60 weeks).
A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase II study to evaluate the efficacy and safety of MABT5102A in patients with mild to moderate alzheimer’s disease
Jan 2011•To evaluate the efficacy of MABT5102A compared with placebo, when administered over 68 weeks to patients with mild to moderate AD, in inhibiting disease progression using the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog [12-item]) •To evaluate the safety and tolerability of MABT5102A compared with placebo when administered over 68 weeks to patients with mild to moderate AD
Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia (IMIEPAP)
Jan 2011The hypothesis of this study is that long-term outcome in elderly patients admitted with the diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) would improve with a multidimensional intervention including assessment of co-morbidities, nutritional, functional and cognitive status and immunization.
A Randomized, Double-blind, Placebo-controlled, Comparative Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of BA058 for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women with Severe Osteoporosis and at Risk of Fracture
Jan 2011Determine the comparative safety and efficacy of 18 months of treatment with BA058 80 µg on reduction of vertebral fracture incidence in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis when compared with Placebo.
Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer
Jan 2011The goals of this pilot study are to estimate the prevalence of secondary causes of osteoporosis in a cohort of patients with nonmetastatic breast and prostate cancer with osteopenia and osteoporosis.
A Double-Blind, Randomized, Repeat Dose, Parallel Group Study of Recombinant Human Parathyroid Hormone (rhPTH(1-31)NH2) tablets, or Placebo tablets, Compared to Open Label Forsteo in Postmenopausal Women with Osteoporosis
Jan 2011To characterize percent change from baseline in bone mineral density (BMD) at L1-L4 axial lumbar spine after 24 weeks of once daily treatment of 5 mg tablets of rhPTH(1 31)NH2.
Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients with Alzheimer’s Disease
Dec 2010The primary objective of the study is to assess the safety of solanezumab in Alzheimer’s disease (AD) patients during 24 months of open-label treatment following completion of 18 months of treatment with solanezumab or placebo in a double-blind registration study (H8A-MC-LZAM [LZAM] or H8A-MC-LZAN [LZAN], “feeder studies”) through analysis of AEs, vital signs, laboratory evaluations, electrocardiograms (ECGs), and MRIs.
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Pain Perception in Parkinson's Disease (rTMS)
Dec 2010This is a randomized, double blind cross-over study. In this study, subjective pain threshold (using thermal stimulation (Thermotest)).will be evaluated in 3 groups of subjects: healthy volunteers, painful Parkinson's patients and pain free Parkinson's disease patients.
A Clinical Trial of Exendin-4 for the Treatment of Alzheimer's Disease
Dec 2010To determine the safety and effectiveness of twice daily administration of Exendin-4 as a treatment for early-stage Alzheimer's disease or mild cognitive impairment.
Pioglitazone in Early Parkinson's Disease
Dec 2010This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility.
Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with “wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study.
Nov 2010To investigate the efficacy of 2 different doses of BIA 9-1067 (25 mg and 50 mg), administered once a day, compared with placebo when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations.
A Single-Arm Open-Label Multi-Center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40
Nov 2010To determine the overall specificity of Flutemetamol (18F) Injection for excluding the presence of brain amyloid based on the visual assessment of a positron emission tomography (PET) scan by independent blinded readers reviewing images from a population of healthy young adult subjects aged 18 to 40.
Sensory Attention Focused Exercise in Parkinson's Disease
Nov 2010The purpose of this study is 1.) to determine if sensory attention focused exercise is an effective management strategy for Parkinson's disease, and 2.) to identify if the benefits are a result of strength gains.
Alzheimer's Disease Neuroimaging Initiative 2 (ADNI2)
Oct 2010The purpose of this study is to build upon the information obtained in the original Alzheimer's Disease Neuroimaging Initiative (ADNI1) and ADNI-GO (Grand Opportunity; a study funded through an NIH grant under the American Recovery and Reinvestment Act), to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). ADNI2 seeks to inform the neuroscience of AD. This information will aid in the early detection of AD, and in measuring the effectiveness of treatments in future clinical trials.
Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial.
Oct 2010Main objective of the trial is the creation of "metabolic profiles" of two important pillars of therapy of Morbus Parkinson, namely Levodopa (+ Benserazide) and Rotigotin. The main focus is on the investigation of stress parameters and nerval growth factors, which are suspected of provoking neural lesions or may counteract such impairments.
Vercise Implantable Stimulator for Treating Parkinson's Disease (VANTAGE)
Oct 2010The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).
A 6-month prospective, multi-center, double-blind, placebo-controlled, randomized, adaptive-trial-design study to evaluate the safety and efficacy of 80mg b.i.d. ladostigil in patients with mild to moderate probable Alzheimer’s Disease with a 6-month open label follow-up period
Sep 2010To evaluate the efficacy of ladostigil (80mg b.i.d) administered for 26 weeks versus matched placebo and the safety of ladostigil (80mg b.i.d) following administration for up to 52 weeks - Alzheimer’s Disease Assessment Scale-Cognitive Subscale (Unmodified, 11 Item, total score = 70): (ADAS-Cog) - Safety evaluation: 26-week and 52-week assessment of safety and tolerability of ladostigil dosing.
Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A two year open label single arm study of teriparatide in secondary care.
Aug 20101. What is the effect of teriparatide on the axial and appendicular skeleton and on cortical and trabecular bone as assessed by QCT? 2. What are the time course and the magnitude of effect of teriparatide on biochemical markers of bone turnover?
A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks
Aug 2010To determine whether PYM50028 exhibits clinical benefit in the treatment of subjects with early-stage Parkinson’s disease (PD), as assessed by the Unified Parkinson’s Disease Rating Scale score for Parts II and III combined (UPDRS II/III), compared with placebo.
A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664)
Jul 2010The primary efficacy objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early Parkinson's disease as measured by the sum of UPDRS Parts 2 and 3 scores. The primary safety objective of this trial is to evaluate the safety and tolerability of preladenant compared to placebo in subjects with early PD.
Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients
Jun 2010The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy. Primary: Safety and tolerability of the decitabine regimen in the post remission state. Secondary: Disease-free survival - To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine as post-consolidation maintenance therapy.
CONCERT PLUS: An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients with Alzheimer's Disease
Jun 2010To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer’s disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.
A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to reduce the Risk of Fracture in Osteoporotic Men Treated with Vitamin D and Calcium
Jun 2010(1) To assess the effect of odanacatib 50 mg once weekly versus placebo on lumbar spine BMD over 24 months; (2)To assess the safety and tolerability of odanacatib 50 mg once weekly compared to placebo.
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson's Disease.
May 2010To evaluate the long-term safety and clinical utility of IPX066 in subjects with Parkinson´s disease (PD).
Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma.
Apr 2010The primary objectives of this phase I/II study are to identify the most appropriate dose of Carfilzomib in combination with a standard Melphalan Prednisone (MP) treatment regimen (phase I) and to evaluate the efficacy of Carfilzomib plus MP (CMP) in terms of overall response rate [(ORR), consisting of complete response (CR), very good partial response (VGPR), and partial response (PR) (phase II)].
Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis
Apr 2010To assess the effects of strontium ranelate in the management of aseptic fractures of the lower limbs with delayed union or non-union.
A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women.
Mar 2010To demonstrate the efficacy of S12911 versus placebo in accelerating radiological healing of distal radius fractures as defined by the bridging in at least 3 out of 4 cortices
An international, multi-centre, randomized, controlled trial evaluating the effect of xenon on post-operative delirium in elderly patients undergoing hip fracture surgery.
Mar 2010The primary objective is to evaluate the incidence of post-operative delirium (POD, diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia, with Xenon or Sevolfurane, for a period of four days post-surgery
Repetitive Transcranial MAgnetic STimulation (rTMS) for MotoR and Mood Symptoms of Parkinson's Disease (MASTER-PD), a Multicenter Clinical Trial
Mar 2010The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS), a method of noninvasive brain stimulation) is effective in the treatment of the motor (movement) and mood symptoms due to Parkinson's disease (PD).
A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography (qEEG) and Event-Related Potentials (ERP) in Patients with Mild-to-Moderate Alzheimer's Disease
Feb 2010To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.
The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.
Nov 2009To assess the efficacy of S6911 after 3 months of treatment
A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E ε4 Noncarriers and Participated in Study 3133K1-3000-WW
Nov 2009The primary objective of study 3133K1-3002-WW is to evaluate the long term safety and tolerability of intravenously administered bapineuzumab in subjects with Alzheimer Disease (AD) based on adverse events, scheduled vital signs, electrocardiogram parameters, clinical laboratory tests, brain MRI scans, physical and neurological examinations, and infusion site assessment. In addition, the studies will be continuously monitored by an independent safety monitoring committee.
Front-line treatment of Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL) with two tyrosine kinase inhibitors (TKI) (Imatinib and Nilotinib). A phase II exploratory multicentric study in elderly patients and in patients unfit for program of intensive therapy and allogeneic stem cell transplantation
Nov 2009The objective of the trial is to evaluate the therapeutic effects of NIL and IM given in turn (in rotation) in terms of Disease-Free Survival (DFS) at 24 weeks (after 4 courses of treatment).
Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
Oct 2009To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.
Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients
Sep 2009To evaluate the long-term safety and tolerability of safinamide (50-100 mg p.o., q. d.) in PD patients.
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer
Aug 2009The purpose of this study is •to determine the rate of osteoporosis among patients with advanced prostate cancer. •to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis
Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION)
Jul 2009This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the Alzheimer's type.
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated with Daily or Weekly Bisphosphonates.
Jul 2009To evaluate the change in total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous daily or weekly bisphosphonate therapy to denosumab 60 mg SC Q6M compared to that in subjects transitioning to ibandronate 150mg PO QM.
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy.
Jun 2009The primary objective of the study is to evaluate the effect of denosumab 60 mg every 6 months (Q6M) compared with Actonel® 150mg monthly (QM) on total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous alendronate therapy.
An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study
May 2009To investigate whether the effect of early-start rasagiline treatment (according to the ADAGIO study protocol) provided long term benefits over delayed-start, and to investigate the long-term effects of rasagiline in PD subjects who participated in the ADAGIO study and have continued on rasagiline treatment.
A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease
May 2009To compare the effect of REQUIP® CR and IR on the discomfort induced by global daytime somnolence in PD patients suffering from REQUIP® IR induced daytime somnolence.
Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease
Apr 2009The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people.
Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Apr 2009The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled study.
Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease (NICOPARK2)
Mar 2009The main objective is to verify the correlation between UPDRS (score III) motor score and the administrated nicotine dose. This study will also allow the evaluation of nicotine neuroprotective effect.
CONNECTION PLUS: An Open-Label Extension of the CONNECTION Protocol (DIM14) Evaluating Oral Dimebon in Patients with Alzheimer’s Disease
Mar 2009To evaluate the long-term safety and tolerability of Dimebon in Alzheimer’s Disease (AD) patients who have successfully completed 26 weeks of blinded treatment in the CONNECTION protocol (DIM14).
A Substudy to Explore Biomarkers of Physical Function in the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated with Vitamin D and Calcium
Mar 2009To evaluate the phenotypic distribution of aLBM, SPPB, and gait speed in the study population. Specifically to determine if, at baseline, measured traits (aLBM, SPPB and/or gait speed) form an appropriate distribution. To identify biomarkers of sarcopenia by evaluating low aLBM, low SPPB, and low gait speed, separately and in combination, by examining DNA and RNA in circulating blood.
Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: “freezing of gait and glutamate: FOGG-I”
Mar 2009analyse de la marche (longueur du pas) avec le système optoélectronique (Vicon®) sur les phases d’initiation et de marche lancée
Evaluation de la captation d'un radioligand des transporteurs de la dopamine chez des sujets atteints de la maladie de Parkison et présentant ou non des douleurs en rapport avec cette pathologie.
Mar 2009L’objectif principal de ce travail est d’étudier la corrélation entre le degré de dénervation de la voie nigro striée objectivée par une scintigraphie cérébrale marquée au FP-CIT et le seuil subjectif de perception douloureuse évalué en thermotest chez des patients parkinsoniens placés en condition médicament OFF
Improving Care of Osteoporosis: Multi-Modal Intervention to Increase Testing and Treatment (ICOMMIITT)
Nov 2008The purpose of this study is to rigorously test the incremental impact of simple, generalizable interventions to improve healthcare among older women at high risk for osteoporosis
Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations.
Oct 2008To investigate if a stable optimal dose of galantamine can prevent an increase or emergence of VH after increase of L-dopa therapy.
A randomised, double blind, placebo-controlled study to evaluate the safety, tolerability and explore the efficacy of zonisamide as add-on therapy in elderly patients with refractory partial seizures.
Oct 2008To compare the effect of add-on treatment with zonisamide to that of placebo on cognition and sedation in an elderly population with refractory partial seizures.
An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium
Sep 2008In postmenopausal women with osteoporosis: To estimate the effect of treatment with MK-0822 50 mg once weekly (OW) on volumetric trabecular bone mineral density (vBMD) at the lumbar spine (assessed by QCT) at Month 12, Month 24, and end of study.
Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients.
Jun 2008Comparaison du score moteur de l'échelle UPDRS (score III) mesuré en état "defined OFF " à la dose maximale de nicotine administrée après 20 semaines de traitement en comparaison au groupe témoin.
Diffuse large B cell non-hodgkin's lymphoma in the vulnerable/frail elderly. A multicentrix randomized phase II trial with emphasis on geritaric assesment and quality of life.
Apr 2008The principal objective of the trial is to assess the therapeutic efficacy (in terms of complete remission at 6 month, as defined by Cheson et al. 1999) and the safety of R-COP and R-COPY in vulnerable/frail elderly patients with diffuse large B cell non-Hodgkin’s lymphoma.
The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women
Apr 2008To evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia.
A randomised, double-blind, double-dummy, oral donepezil controlled study on the safety and efficacy of repeated monthly subcutaneaous injections of a sustained-release implant of ZT-1 in patients with moderate Alzheimer’s Disease (AD)
Feb 2008The main objectives of this study are to assess the efficacy of the ZT-1 implant in improving cognitive function, behavioural and overall outcomes, compared to oral daily doses of donepezil and to assess the safety of the ZT-1 implant, compared to oral daily doses of donepezil.
Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.
Dec 2007To evaluate the efficacy of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease.
Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with Dementia of the Alzheimer’s Type
Nov 2007Main objective of the trial is to evaluate the safety of long term treatment with MPC-7869
A 52-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in patients with mild Alzheimer’s Disease (AD) to investigate the safety and tolerability of repeated subcutaneous injections of CAD106
Sep 2007To evaluate the safety and tolerability of repeated subcutaneous (s.c.) injections of 150μg CAD106 in patients with mild AD over the 52 weeks of the study.
The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.
Sep 2007To demonstrate the efficacy over 1 year of strontium ranelate compared to placebo on lumbar BMD in men with osteoporosis.
A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years.
Aug 2007The main objectives of this study are: to assess the safety and tolerability of bevacizumab added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and to assess in a randomized comparison the effect of bevacizumab on the CR rate.
An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine administered by Intradermal Route (Flu-ID 15μg) versus an Inactivated adjuvanted Influenza Vaccine administered by Intramuscular Route (Addigrip® 15µg) in subjects 65 years of age or older
Jul 2007To demonstrate that the influenza vaccine administered by intradermal (ID) route at the dose of 15μg is at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular (IM) route at the same dosage in term of HA antibody titres for the three strains at Day 21 post-vaccination.
Influence of urinary acidification by l-Methionine on bone metabolism and acid base status
Jun 2007To assess the impact of l-methionine intake on bone metabolism.
An Open-Label Extension of the Phase III Study CL-758010 with Alzhemed™ in Patients with Alzheimer’s Disease.
Mar 2007The primary objective of this open-label study is to evaluate the long-term safety of Alzhemed™ in patients with Alzheimer’s Disease (AD).
A double-blind, multicenter, international randomised study to assess the effects of 6 months or 12 months administration of 2g per day of strontium ranelate versus alendronate 70mg per week on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis
Feb 2007To assess the effects of 6 or 12 months treatment of strontium ranelate in comparison with alendronate on bone formation assessed by histomorphometry on transiliac paired biopsies performed in patients with postmenopausal osteoporosis treated for 1 year.
Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures (AVOID Fracture)
Oct 2006The intent of this research is to improve quality of care for patients at high risk of fracture, by increasing rates of testing and treatment of osteoporosis.
Recognizing Osteoporosis and Its Consequences in Quebec (ROCQ) Programme
Jul 2006The aim of the ROCQ programme is to improve the use of evidence based osteoporosis diagnostic and treatment strategies for women 50 years and over who have suffered a fragility fracture.
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