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DHEA treatment of Alzheimer’s disease

A randomized, double-blind, placebo-controlled study

*See the Appendix on page 1076 for a listing of members of the DHEA-Alzheimer’s Disease Collaborative Research Group.
From the Departments of Psychiatry (Drs. Wolkowitz, Kramer, Reus, Costa, and Yaffe, and P. Walton) and Neurology (Dr. Yaffe) and Center for Neurobiology and Psychiatry (Drs. Wolkowitz and Reus), University of California San Francisco (UCSF) School of Medicine; Alzheimer’s Disease Research Center and Department of Psychiatry and Behavioral Sciences (Drs. Raskind and Peskind), University of Washington School of Medicine and VA Puget Sound Health Care System, Seattle, WA; Department of Psychiatry (Dr. Newhouse), University of Vermont College of Medicine, Burlington; Institute for Psychopharmacology Research (Dr. Sack), Cerritos, CA; Neurocrine Biosciences, Inc. (Dr. De Souza), San Diego, CA (current affiliation: Aventis Pharmaceuticals, Inc., Bridgewater, NJ); Premier Research Institute (Dr. Sadowsky), West Palm Beach, FL; and Department of Neurobiochemistry (Dr. Roberts), Beckman Research Institute, City of Hope National Medical Center, Duarte, CA.

Address correspondence and reprint requests to Dr. Wolkowitz, 401 Parnassus Ave., Box F-0984, San Francisco, CA 94143-0984; e-mail: owenw{at}itsa.ucsf.edu

Objective: To compare the efficacy and tolerability of dehydroepiandrosterone (DHEA) vs placebo in AD.

Method: Fifty-eight subjects with AD were randomized to 6 month’s treatment with DHEA (50 mg per os twice a day; n = 28) or placebo (n = 30) in a multi-site, double-blind pilot trial. Primary efficacy measures assessed cognitive functioning (the AD Assessment Scale–Cognitive [ADAS-Cog]) and observer-based ratings of overall changes in severity (the Clinician’s Interview-Based Impression of Change with Caregiver Input [CIBIC-Plus]). At baseline, 3 months, and 6 months, the ADAS-Cog was administered, and at 3 and 6 months, the CIBIC-Plus was administered. The 6-month time point was the primary endpoint.

Results: Nineteen DHEA-treated subjects and 14 placebo-treated subjects completed the trial. DHEA was relatively well-tolerated. DHEA treatment, relative to placebo, was not associated with improvement in ADAS-Cog scores at month 6 (last observation carried forward; p = 0.10); transient improvement was noted at month 3 (p = 0.014; cutoff for Bonferroni significance = 0.0125). No difference between treatments was seen on the CIBIC-Plus at either the 6-month or the 3-month time points.

Conclusions: DHEA did not significantly improve cognitive performance or overall ratings of change in severity in this small-scale pilot study. A transient effect on cognitive performance may have been seen at month 3, but narrowly missed significance.

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