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06-07-2007, 07:47 PM | #1 | |||
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Senior Member
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(emphasis is mine)
From Phytopharm 2006 annual report: In late November 2005 we announced the preliminary results obtained from the Phase IIa clinical study of Cogane™ in mild and moderate Alzheimer’s disease patients. The Oxford Project to Investigate Memory and Ageing (OPTIMA) was the lead clinical centre and 15 other sites in the UK Two hundred and fifty-six subjects with Alzheimer’s disease ranging in severity from mild to moderate were randomly allocated to receive either 120 mg Cogane™ (n = 127) or a placebo (n = 129), orally once daily for 12 weeks. The majority of patients enrolled had mild disease. The baseline demography data confirmed that the treatment groups were well balanced for factors such as age, gender and severity of disease. The overall safety data confirmed that Cogane™ administered orally once daily for up to 12 weeks is well tolerated and has a good overall clinical safety profile. There were no substantial differences in the adverse event and laboratory safety data for each group. The prospectively defined primary efficacy measures were cognitive assessments measured using CANTAB-PAL and the Hopkins verbal learning test. The baseline scores and changes over time were not significantly different between the groups. Although the Phase IIa clinical trial was not of a sufficient duration to observe deterioration in cognitive function in the group of Alzheimer’s patients whose disease severity included both mild and moderate disease, a subset analysis on the smaller number of patients with moderate Alzheimer’s disease showed a trend towards deterioration in the placebo group, with no significant deterioration observed in the Cogane™ group. This encouraging trend for slower disease progression in more moderate Alzheimer’s patients with Cogane™ coupled with its excellent tolerability, confirms the need for longer term studies for efficacy determination. Further work has now been initiated in preparation for further clinical studies and discussions with potentially suitable licensees have progressed to detailed evaluations and due diligence assessments of the full data set.
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