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ADCS Prevention Instrument Project: overview and initial results.

Steven H Ferris¹, Paul S Aisen, Jeffrey Cummings

¹Alzheimer's Disease Center, New York University School of Medicine, New York, NY 10016, USA. steven.ferris@med.nyu.edu

Alzheimer Disease and Associated Disorders

|December 1, 2006

Summary

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Area of Science:

Gerontology and Geriatric Medicine
Neuroscience and Neurodegenerative Diseases
Clinical Trial Methodology

Background:

Primary prevention trials for Alzheimer's disease (AD) require novel assessment instruments.
Existing methods may not be suitable for long-term, large-scale prevention studies.
The Alzheimer's Disease Cooperative Study (ADCS) aims to improve AD clinical trial assessments.

Purpose of the Study:

To develop and evaluate home-based instruments for primary prevention trials in Alzheimer's disease.
To assess the feasibility, efficiency, and validity of home-based versus clinic-based assessments.
To measure cognitive function, behavior, and quality of life in non-demented elderly individuals.

Main Methods:

A 4-year longitudinal study simulating a primary prevention trial design.
Recruitment of 644 non-demented elderly subjects (≥75 years), with 23% showing mild cognitive symptoms.
Randomization into home-based or clinic-based assessment groups; annual in-clinic evaluations and self-administered home instruments.

Main Results:

Confirmed the feasibility of collecting clinical information at home via mail or telephone.
Baseline results and initial longitudinal outcomes through 2 years of follow-up are presented.
The study design effectively simulates primary prevention trial conditions for instrument evaluation.

Conclusions:

Home-based assessment instruments are feasible for Alzheimer's disease prevention trials.
These novel instruments can assess key domains relevant to AD onset and progression.
The study provides a foundation for evaluating interventions aimed at delaying AD onset.