Conditions: Alzheimer Disease
Keywords: Alzheimer disease moderate-to-severe memantine safety and efficacy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 86
Healthy volunteers: no

Brief summary:
No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

Detailed description:
This study was terminated on May 7, 2010 due to modification of the dimebon development plan following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Dimebon 20 mg po TID intervention 2: Placebo po TID
Intervention descriptions: intervention 1: Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks intervention 2: Placebo (matched to Dimebon) po for 26 weeks

Protocol document: