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Dimebon drug trial fails to meet primary endpoint: Medivation, Pfizer report

Medivation, a biopharmaceutical company, and Pfizer have reported results from the Phase 3 Concert trial, which assessed dimebon (latrepirdine) to treat Alzheimer's disease when added to ongoing treatment with donepezil HCL tablets.

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.