NYU Aging and Dementia Research Center (ADRC) Contributes to New Treatments for Severe Alzheimer’s Disease

In the fall of 2006, the FDA granted approval to Aricept® (donepezil) for the treatment of advanced Alzheimer’s disease. Previously used to treat mild and moderate forms of the disease, the approval of the additional use was based on pivotal trials conducted in Sweden and Japan, which used the Functional Assessment Stages (FAST) for patient characterization. The FAST was developed by Barry Reisberg, M.D., Clinical Director of the NYU Aging and Dementia Research Center (ADRC), the clinical research and service program of the Silberstein Institute for Aging and Dementia. First developed over 20 years ago, the FAST is a 16-item assessment tool, based on the patient’s level of practical functioning, used to aid in the diagnosis and staging of Alzheimer’s disease—ranging from normality to most severe dementia of the Alzheimer’s type. The instrument was designed as an improvement over the previous diagnostic model (based on the Diagnostic and Statistical Manual of Mental Health Disorders), and is currently one of several tools available to clinicians in the diagnosis of Alzheimer’s.

These pivotal trials of donepezil in severe Alzheimer’s disease used a trial design pioneered by Dr. Reisberg and his colleague, Steven Ferris, Ph.D., the ADRC Executive Director, which was first published in the New England Journal of Medicine in 2003. In this randomized clinical trial, Dr. Reisberg and colleagues investigated the efficacy of memantine in outpatients with moderate-to-severe Alzheimer’s disease. Based on the results of the study—which showed that the treatment reduced clinical deterioration in the participants—memantine (Nameda®) was approved by the FDA later that year as the first medication for the treatment of more advanced Alzheimer’s patients.

While the diagnosis of Alzheimer’s disease can be devastating for the patient and his or her loved ones, donepezil, memantine, and other medications can help slow the progression and help the patient maintain higher levels of functioning.

The NYU Aging and Dementia Research Center is one of the oldest and most comprehensive clinical research centers in the world focusing on age-associated cognitive decline, mild cognitive impairment, and Alzheimer’s disease. The ADRC is pleased to be contributing significantly to the treatment of Alzheimer’s patients and the alleviation of some of the burden associated with this disease. For more information on their clinical and research activities, please visit the Center's website.