Phase III clinical trial of GV 971 shows promise in Alzheimers disease.- Green Valley Pharma.
Green Valley Pharmaceutical Co announced promising findings from a Phase III clinical trial of GV 971, a multi targeting carbohydrate-based drug, with 818 patients across 34 sites in China for treatment of patients with mild-to-moderate Alzheimer's disease. In this double-blind, placebo-controlled, multi-center trial, 818 patients were randomized to receive either GV-971 450mg twice per day by oral administration or placebo for a treatment period of 36 weeks. The trial participants were between 50-85 years old, met clinical criteria for mild-to-moderate Alzheimer's disease, had MMSE scores of 11-26, and MRI evidence included medial temporal lobe atrophy visual rating scale (MTA) grade at least 2, Fazekas scale for white matter lesions grade less than 3, no more than 2 lacunar infarction lesions and no lacunar infarction lesions in the key brain regions.
The primary efficacy end point was the change from baseline to week 36 on the ADAS-Cog 12, the secondary efficacy end points included the change from baseline to week 36 on CIBIC plus, ADCS-ADL and NPI. The safety evaluation includes AE, laboratory assessment, vital signs, ECGs, physical examinations. GV-971 showed statistically significant improvement on the primary endpoint ADAS-Cog12 (p<0.0001). the mean difference between gv 971 vs. placebo in adas-cog12 score at 36 weeks was 2.54. this statistically significance difference between gv 971 vs. placebo was observed as early as week 4 and continued at each follow-up assessment visit. the drug placebo difference was also statistically significant in all three subgroups of patients with mmse scores ranging from 11-14, 15-19 and 20-26. there was a non-significant trend for greater improvement on the cibic-plus (p="0.059).">
No statistically significant differences were observed in ADCS-ADL or NPI. The twice per day oral drug treatment was found to be safe and well tolerated. There were no statistically significant group differences in the percent of participants with adverse or severe adverse effects. Data were presented at the 11th Clinical Trials on Alzheimer's Disease Conference.
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