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Executive Summary

ELDEPRYL ALZHEIMER's STUDY ON PROTECTION AGAINST NEURODEGENERATION effects from the disease has begun enrolling patients under the auspices of the National Institute of Aging's Alzheimer's Disease Cooperative Study Unit (ADCSU). The two-year study by NIA's Alzheimer's study unit will test the ability of Eldepryl (Somerset's selegiline) to protect against the neurological degeneration that occurs in Alzheimer's patients. Eldepryl, which is copromoted by Sandoz as an adjunctive therapy to DuPont's Sinemet (levodopa) in Parkinson's disease, is the first therapy to be tested by the ADCSU, which was established in October 1991 to conduct preliminary evaluation of drugs to determine if more in-depth trials in Alzheimer's patients are warranted ("The Pink Sheet" Oct. 7, 1991, T&G-8). In a press release announcing the startup of the study, ADCSU Project Director Mary Sano, PhD, Columbia University Neurological Institute, noted that "previous Alzheimer's studies concentrated only on symptomatic relief." Sano called the Eldepryl study "very significant...because it is testing a compound that may affect the disease process and slow the progression of Alzheimer's." The ADCSU trial is also the first large-scale study to enroll patients with moderate, rather than just mild, dementia. In addition to cognitive measures, the study will evaluate quality of life. The study endpoints will include the patient's ability to perform basic activities, delay in institutionalization and survival. The 370-patient trial will be conducted in 23 of the 32 centers involved in the ADCSU national consortium. Alzheimer's disease researcher Leon Thal, MD, University of California-San Diego, will serve as principal investigator. Thal is a member of FDA's Peripheral & Central Nervous System Drugs Advisory Committee and was an investigator for the clinical trials of Warner- Lambert's Cognex (tacrine). Selegiline, which is a monoamine oxidase inhibitor that may block oxidative damage to certain brain cells, will be studied alone and in combination with alpha tocopherol, a component of vitamin E that acts as a free radical scavenger. In a study by Schoulson et al., University of Rochester, reported in the Jan. 21 issue of the New England Journal of Medicine, tocopherol did not appear to augment selegiline's beneficial effects in patients with early Parkinson's disease. Eldepryl therapy alone, however, delayed by nine months the onset of disability requiring levodopa. Eldepryl has been studied previously in small numbers of Alzheimer's patients. A study by Schneider et al., University of Southern California, in the American Journal of Psychiatry reported on 10 Alzheimer's patients who were already receiving Cognex or sustained-release physostigmine (Forest's Synapton SR). Selegiline at low doses (5 mg b.i.d.) added to cholinesterase treatment led to a mean improvement on the seven-point Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS COG) of 2.5 points compared to placebo. The Eldepryl study is being supported entirely by NIA, which is funding the ADCSU project through an $18 mil. five-year grant to the UCSD School of Medicine. At present, Sandoz and Somerset (a joint venture of Mylan and Circa) said they are not planning to conduct Eldepryl studies in Alzheimer's patients or pursue regulatory approval for that indication. Waxman/Hatch exclusivity for Eldepryl expires in June 1994 and the drug's exclusivity as an orphan product runs out in June 1996.

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