Donepezil plus Latrepiridine Are Safe and Well Tolerated when Used in Combination in Patients with Mild to Moderate Alzheimer's Disease

Data presented Sunday, July 12 at the 2009 International Conference on Alzheimer’s Disease in Vienna, Austria show that combination therapy with the investigational drug dimebon (latrepiridine) and donepezil HCl tablets was well tolerated in patients with mild to moderate Alzheimer’s disease.

Data from phase I of the CONCERT study (poster # P1-254) showed that patients reported no serious adverse events, and that most adverse events were characterized as mild to moderate.

In a press release issued by Pfizer and dimebon co-developer Medivation study investigator Pierre Tariot, MD, said that “Every patient is uniquely affected by Alzheimer’s disease and management is often complex. Combination therapy may be needed to maximize clinical benefit, but limited treatment options are available currently.” Tariot, who is director of the Memory Disorders Center at Banners Alzheimer’s Institute, also said that “Phase 1 data are encouraging, and served as the foundation for the ongoing Phase 3 CONCERT study, which recently started enrollment in the US and internationally.”

The study abstract, titled “A safety, tolerability and pharmacokinetic study of dimebon in patients with Alzheimer's disease already receiving donepezil,” is available here http://download.journals.elsevierhealth.com/pdfs/journals/1552-5260/PIIS1552526009003847.pdf

More about the CONCERT Study

The official title of the CONCERT study is “CONCERT: A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Safety and Efficacy Study Evaluating Dimebon in Patients with Mild-to-Moderate Alzheimer's disease on Donepezil.”

The study is designed to determine if dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on donepezil. The study is recruiting men and women age 50 years and older. Eligibility criteria include mild-to-moderate Alzheimer's disease; probable AD (DSM-IV-TR); MMSE score between 12 and 24, inclusive; and stable treatment with donepezil for at least 6 months.

Patients are excluded from participating if their dementia is due to causes other than AD, if they have major structural brain disease, and/or if they have an unstable medical condition or significant hepatic or renal disease.

Learn more here.