Medivation initiates dosing in second Phase III Alzheimer’s disease trial

The international, double-blind, placebo-controlled safety and efficacy study of oral Dimebon is known as the Connection study.

The Connection study will enroll approximately 525 patients with mild-to-moderate Alzheimer’s disease at approximately 100 sites in the US, Europe and South America. Patients will be randomized to one of three treatment groups: Dimebon 20mg three times per day, Dimebon 5mg three times per day or placebo.

Patients may not be taking any other Alzheimer’s disease drugs during the trial. After completing six months of treatment, all patients – including those randomized to placebo – will be offered the opportunity to receive Dimebon in an extension trial until marketing authorization.

The primary endpoints of the trial are the Alzheimer’s disease assessment scale – cognitive subscale (ADAS-cog) and the clinician’s interview-based impression of change plus caregiver interview (CIBIC-plus). These are the two endpoints that have been accepted by the FDA to support registration of all approved drugs for Alzheimer’s disease.

Lynn Seely, chief medical officer of Medivation, said: “The initiation of this study brings us a major step closer to our goal of obtaining regulatory approval for Dimebon. We are working to bring this investigational drug to market as quickly as possible to address the unmet medical need in Alzheimer’s disease and bring hope to patients and caregivers.”