Sun City, Ariz. (August 3, 2009)– Sun Health Research Institute today announced it has begun enrolling patients with Alzheimer’s disease in the CONCERT study, a new clinical trial that will test the efficacy of a unique investigational drug, dimebon (latrepirdine)*, in patients 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 Marwan Sabbagh MD, chief medical/scientific officer at Sun Health Research Institute. “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.
About Sun Health Research Institute
For 23 years, Sun Health Research Institute, part of nonprofit Banner Health, has been a leader nationally and internationally in the effort to find answers to disorders of aging including Alzheimer’s disease, Parkinson’s disease and arthritis. The institute, together with its Arizona Alzheimer’s Consortium partners, has been designated by the National Institutes of Health as one of just 29 Alzheimer’s Disease Centers in the nation. The institute’s Cleo Roberts Center for Clinical Research takes laboratory discoveries to clinical trials that foster hope for new treatments. Banner Health is Arizona’s leading health care provider and second largest private employer. For more information, visit www.shri.org and www.bannerhealth.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 AD 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.
About Dimebon
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
For more information on eligibility and enrollment, patients and caregivers can call Sun Health Research Institute at 623-875-6500 or visit www.concertstudy.com.
Media Contact:
Brian Browne
Sun Health Research Institute
(623) 875-6536
brian.browne@bannerhealth.com