LEXINGTON, Ky. (May 11, 2010) – The University of Kentucky Sanders-Brown Center on Aging has begun enrolling patients with Alzheimer’s disease (AD) in the CONCERT study, a clinical trial that will test the efficacy of a unique investigational drug, dimebon (latrepirdine)*, in patients also currently taking Aricept® (donepezil HCI tablets), the leading Alzheimer’s disease medication worldwide.
"Alzheimer's is a complex disease and while current medications address symptoms for some patients, the disease often requires combination therapy to maximize clinical benefit," said Dr. Gregory Jicha, assistant professor of neurology, UK College of Medicine, and faculty member in the UK Sanders-Brown Center on Aging and UK Alzheimer's Disease Research Center. "CONCERT is an important study because dimebon is thought to work differently than current medications and this study will evaluate whether adding it to one of the most commonly used Alzheimer’s medications will provide more effective symptomatic treatment to patients."
While a cure is still many years away, treatments that provide lasting effects, more complete symptomatic benefits or slow disease progression would be meaningful advances for patients and caregivers; for this reason there is an urgent need for patients to participate in clinical trials to help advance the understanding of how Alzheimer’s disease can be better treated.
According to estimates from the Alzheimer’s Association, 5.3 million people in the United States are living with Alzheimer's, a devastating disease that hinders a patient’s ability to remember, learn, perform daily activities and relate to others. As the baby boomer population ages, the incidence of Alzheimer's is expected to increase dramatically.
For more information on eligibility and enrollment, patients and caregivers can call Stephanie Freeman at (859)-257-1412 ext. 234 or firstname.lastname@example.org or the CONCERT study hotline toll-free at (877) 888-6386, or go to www.concertstudy.com
About the CONCERT Study
CONCERT is an international, randomized, double-blind, placebo-controlled study that will enroll approximately 1,050 patients with mild-to-moderate Alzheimer's disease at approximately 100 sites in the United States, Australia, New Zealand and Western Europe. Patients on a stable dose of Aricept will be randomized to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times per day or placebo.
The primary endpoints are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL), a measure of self-care and daily function.
The CONCERT study is sponsored by Pfizer and Medivation, Inc.
Dimebon (latrepirdine) is an investigational drug currently in Phase 3 development for the treatment of Alzheimer's disease and in clinical development for Huntington disease (HD). The comprehensive Phase 3 clinical development program for Alzheimer’s disease is evaluating the potential for dimebon to be used in broad applications including use alone, in combination with existing medications and in patients at all stages of the disease.
Dimebon has a unique mechanism of action, distinct from currently available treatments. In preclinical studies, dimebon has been shown to protect brain cells from damage and enhance brain cell survival, potentially by stabilizing and improving mitochondrial function.
Mitchondria are critical to brain cell functioning as they are the primary source of energy for cells. Drugs that protect mitochondria or restore their function could potentially be a valuable treatment approach in AD.
* Latrepirdine is the proposed generic (nonproprietary) name for dimebon.