The data demonstrated that Dimebon did not achieve statistically significant results for either of the two co-primary endpoints including the Alzheimer’s Disease Assessment Scale and the Alzheimer’s Disease Cooperative Study.
The Alzheimer’s Disease Assessment Scale comprises cognitive subscale (ADAS-cog), which measures cognitive ability while the Alzheimer’s Disease Cooperative Study includes Activities of Daily Living (ADCS-ADL), which measures self care and daily function.
Dimebon was, however, well tolerated in the study.
The 12-month global randomized, double-blind, placebo-controlled trial enrolled 1,003 patients with Alzheimer’s disease.
Patients on a stable dose of donepezil for at least four months were randomized to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times per day or placebo.