At a glance
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A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer's Disease
In Brief
A Phase 3 clinical trial evaluating Dimebon and Placebo for Alzheimer's Disease. Completed, enrolled 742 participants across 118 sites in 3 countries.
Detailed Summary
This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.
Study Details
Timeline
Interventions
10 mg TID for week 1 followed by 20 mg TID through Week 26
10 mg TID for week 1 followed by 20 mg TID through Week 26
10 mg TID for week 1 followed by 20 mg TID through Week 12
20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12