Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease Dimebon Safety Tolerability
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 742
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Dimebon intervention 2: Placebo intervention 3: Dimebon intervention 4: Placebo
Intervention descriptions: intervention 1: 10 mg TID for week 1 followed by 20 mg TID through Week 26 intervention 2: 10 mg TID for week 1 followed by 20 mg TID through Week 26 intervention 3: 10 mg TID for week 1 followed by 20 mg TID through Week 12 intervention 4: 20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12

Protocol document: