Trial of Reminyl XL/Razadyne (Janssen Pharmaceuticals) shows positive results in patients with Alzheimer's Disease

A new study shows a significantly lower mortality rate in patients with mild to moderately severe Alzheimer's disease who were treated with Reminyl XL/Razadyne (galantamine), from Janssen Pharmaceuticals, versus those on placebo. Patients treated with galantamine also had significantly lesser decline in cognitive impairment after two years.

The trial enrolled 2,051 people and was conducted at 127 sites in 13 countries. At the final interim mortality analysis, an independent Data Safety Monitoring Board recommended early termination of the study due to an imbalance of deaths between the treatment group and the placebo group. Data indicated that mortality was statistically significantly lower in patients treated with galantamine, compared to patients who received placebo [3.1 percent versus 4.9 percent respectively]. In the final analysis, there was a total of 89 deaths; 33 (3.2 percent) in the galantamine group and 56 (5.5 percent) in the placebo group. The treatment group also had significantly lesser cognitive decline measured by the change from baseline in the Mini Mental Status Evaluation (MMSE) at month 24 of the study, compared to placebo.

The mean MMSE scores deteriorated from a baseline of 19 to 16.9 and 17.5 for the placebo and galantamine groups, respectively. Additionally, there was a significantly greater decline from baseline in MMSE at month 6 in the placebo group compared with the galantamine group. Data were presented at the American College of Neuropsychopharmacology 51st Annual Meeting.