DHEA treatment of Alzheimer's disease: A randomized, double-blind, placebo-controlled study

Department of Psychiatry, Center for Neurobiology and Psychiatry, University of California San Francisco (UCSF) School of Medicine, USA.
Neurology (Impact Factor: 8.29). 05/2003; 60(7):1071-6. DOI: 10.1212/01.WNL.0000052994.54660.58
Source: PubMed


To compare the efficacy and tolerability of dehydroepiandrosterone (DHEA) vs placebo in AD.
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.
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.
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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Available from: Eugene -- Roberts, May 14, 2015
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    • "A trial in mild-to-moderate AD of atorvastatin enrolled 98 participants, of whom 15 withdrew consent prior to random assignment 'primarily to participate in other trials' [35]. Similarly, the ADCS trial of dihydroepiandrosterone initially recruited 58 participants, but only 33 completed the 12-month trial [36]. Fifty-three percent of subjects randomly assigned to placebo dropped out of the study prior to completion, and the authors hypothesized that the high rate of dropout may have been the result of the widespread availability of FDA-approved AChEI therapies during study conduct [36]. "
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    Alzheimer's Research and Therapy 12/2010; 2(6):34. DOI:10.1186/alzrt58 · 3.98 Impact Factor
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    • "No studies of DHEA replacement on healthy elderly populations, either acute administration or chronic (up to 12 months) supplementation, have shown a benefit in memory with treatment (Wolf et al. 1997, 1998; Wolf and Kirschbaum 1999; Arlt et al. 2001; Grimley Evans et al. 2006; Kritz- Silverstein et al. 2008), and some have even observed a negative effect on memory (Wolf et al. 1998; Parsons et al. 2006). DHEA supplementation has also shown no benefit in the treatment of Alzheimer's disease (Wolkowitz et al. 2003). "
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    Age 09/2009; 32(1):61-7. DOI:10.1007/s11357-009-9113-4 · 3.45 Impact Factor
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    • "DHEA is widely consumed as a drug for a wide range of expected therapeutic actions, including androgen synthesis [10], improvement of degenerative diseases [11] and the treatment of overweight and obesity [12,13]. The rapid absorption and disposal of oral DHEA [14] has generated a number of studies and patents focussed on the maintenance of plasma DHEA levels within a therapeutic range in spite of its rapid metabolism/excretion. "
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