Alzheimer's Disease Cooperative Study
The Alzheimer's Disease Cooperative Study (ADCS) was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California San Diego. The ADCS is a major initiative for Alzheimer's disease (AD) clinical studies in the Federal government, addressing treatments for both cognitive and behavioral symptoms. This is part of the NIA Division of Neuroscience's effort to facilitate the discovery, development and testing of new drugs for the treatment of AD and also is part of the Alzheimer's Disease Prevention Initiative.
The ADCS was developed in response to a perceived need to advance research in the development of drugs that might be useful for treating patients with Alzheimer's disease (AD), particularly drugs that might not be developed by industry. As such, the mandate of the ADCS is to:
* Improve cognition, slow the rate of decline, or delay the appearance of AD.
* Develop studies for promising agents designed to ameliorate behavioral symptoms.
* Design new instruments for use in clinical studies.
* Conceive of novel and innovative approaches to clinical study design and AD clinical study analysis.
* Expand the range of patients studied in AD studies.
* Enhance the recruitment of minority groups into AD studies.
The ADCS focuses on evaluating compounds that will benefit the general good of AD patients. This includes the testing of agents that lack patent protection, are under patent protection but are already marketed for other indications but where the agent may be useful in treating AD, and are novel compounds developed by individuals, academic institutions and drug discovery units.
Since 1991, the ADCS has initiated 30 research studies (23 drug studies and 7 instrument development protocols) with the majority of studies carried out at 20 or more AD research centers. The number of participants enrolled in these Phase I to Phase III research studies have ranged from 9 to 800 people per study. ADCS studies have generated numerous publications. Some key highlights of ADCS activities include:
* Development of AD centers capable of carrying out AD studies in the United States and Canada.
* Establishment of a robust Administrative, Data, Operations and Medical Cores based in San Diego.
* Development of important new instruments including the first Activities of Daily Living Scale specifically developed for AD patients, and standardization of the Clinical Global Impression of Change.
* Standardization and development of worksheets for the use of the Clinical Dementia Rating Scale.
* Completion of a protocol testing vitamin E and selegiline which demonstrated that both agents can cause approximately a six month delay in the time for moderately advanced AD patients to reach important endpoints including progression from moderate to severe dementia, loss of basic activities of daily living, institutionalization, and death.
* Development of the concept of mild cognitive impairment as a treatable entity and development of a clinical study to delay conversion from mild cognitive impairment to AD.
* Completion of a placebo-controlled, multi-center outpatient study of agitation in AD patients including two drug arms and one behavioral management arm.
* Completion of a number of studies with enormous scientific and public health impact, including studies demonstrating the lack of benefit associated with the use of estrogen, non-steroidal anti-inflammatory drugs, B vitamins and a statin drug for the treatment of AD.
* Widespread sharing of assessment tools, trial methods and data with academic investigators and commercial entities around the world.
Provision of infrastructure support to other federally funded clinical efforts, including the Alzheimer's Disease Neuroimaging Initiative.
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