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L-deprenyl in Alzheimer's disease

Cognitive and behavioral effects

From the Behavioural Neurology Program and Rotman Research Institute (Dr. Freedman, T. Xerri, and Dr. Cohen), and Department of Psychology (Dr. Rewilak), Baycrest Centre for Geriatric Care; Department of Medicine(Neurology) (Drs. Freedman, Cohen, Gordon, and Shandling) and Division of Clinical Epidemiology, Samuel Lunenfeld Research Institute (Dr. Logan), Mt. Sinai Hospital and University of Toronto, Ontario, Canada.

Address correspondence and reprint requests to Dr. M. Freedman, Behavioural Neurology Program, Baycrest Hospital, Rm 4W-36, 3560 Bathurst Street, North York, Ontario M6A 2E1, Canada.

Background: Short-term studies of L-deprenyl in Alzheimer's disease (AD) suggest a beneficial effect, whereas longer-term studies are less convincing. Accordingly, we undertook a 6-month, randomized, double-blind, placebo-controlled clinical trial to assess the potential benefit of L-deprenyl in AD.

Methods: Sixty subjects were assigned to L-deprenyl (10 mg daily) or placebo. After 4 weeks of single-blind placebo, 51 subjects entered the double-blind phase. The Brief Psychiatric Rating Scale (BPRS) was the primary outcome measure. Secondary outcome measures were the Mini-Mental State Examination, Global Deterioration Scale, Alzheimer's Disease Assessment Scale (noncognitive), Cornell Scale for Depression in Dementia, Buschke Selective Reminding Test(BSRT), Relative's Assessment of Global Symptomatology-Elderly (RAGS-E), Controlled Oral Word Association Test, and Modified Continuous Performance Test. In addition, several exploratory tasks were included for future hypothesis testing.

Results: We found no significant differences between the L-deprenyl and placebo groups on the primary or secondary measures. However, several measures appeared to be sensitive to change over time, including the total score on the BPRS and some of its components as well as parts of the BSRT and the RAGS-E.

Conclusion: Oral L-deprenyl provides no detectable benefit on general behavior, neuropsychiatric symptoms, or cognitive function in AD after 6 months of treatment. Protocols for future drug studies should utilize measures that are sensitive to change over time such as the BPRS.

Supported by a grant from the Ministry of Health of Ontario under the auspices of the Ontario Mental Health Foundation. Draxis Health Inc.(formerly Deprenyl Research Ltd.) provided the active L-deprenyl tablets and identical placebos. Dr. Freedman was supported by a Career Scientist Award from the Ministry of Health of Ontario.

Presented in part at the Lancet Conference, "The Challenge of the Dementias," Edinburgh, Scotland, April 1996.

Received October 9, 1996. Accepted in final form September 29, 1997.

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