Clinical Endpoints in Dementia Studies: Are They Relevant?

• Activity Number: 25
• Type: Invited
• Date/Time: Sunday, August 11, 2002 : 4:00 PM to 5:50 PM
• Sponsor: ENAR
• Author(s): Sean Lilienfeld*+
• Affiliation(s): Janssen Research Foundation

Abstract

Alzheimer's disease (AD) is the most frequent cause of dementia and represents loss of recent memory as the most common symptom. Patients with dementia progressively develop additional signs and symptoms of disease, such as functional decline, as well as behavioral and psychological disturbances. Decline in basic activities of daily living (ADL) contributes greatly to the patient's loss of independent living. The consequences of AD have stimulated considerable research into developing effective treatments for improving quality of life for patients and care givers. Effective pharmacotherapies may help many AD patients from being institutionalized by delivering sustained, favorable, positive effects on cognitive, functional and behavioral symptoms of Alzheimer's disease. Rather than simply assessing the efficacy of drugs for Alzheimer's disease patients according to 'improvement over baseline' or 'improvement versus placebo' criteria, one should also focus on the benefits to caregivers--accruing from 'disease maintenance' to help avoid underestimating the overall treatment effect. Therefore, maintaining cognitive and functional abilities in the long-term should be considered clinically relevant, particularly for an illness like Alzheimer's disease in which the average duration of survival from diagnosis is 5-8 years.