title: DHEA treatment of Alzheimer's disease: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  To compare the efficacy and tolerability of dehydroepiandrosterone (DHEA) vs placebo in AD.
  
  
  METHODS
  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.
authors.affiliation: Department of Psychiatry, Center for Neurobiology and Psychiatry, University of California San Francisco (UCSF) School of Medicine, USA. owenw@itsa.ucsf.edu
authors.forename: O M
authors.initials: OM
authors.lastname: Wolkowitz
authors.forename: J H
authors.initials: JH
authors.lastname: Kramer
authors.forename: V I
authors.initials: VI
authors.lastname: Reus
authors.forename: M M
authors.initials: MM
authors.lastname: Costa
authors.forename: K
authors.initials: K
authors.lastname: Yaffe
authors.forename: P
authors.initials: P
authors.lastname: Walton
authors.forename: M
authors.initials: M
authors.lastname: Raskind
authors.forename: E
authors.initials: E
authors.lastname: Peskind
authors.forename: P
authors.initials: P
authors.lastname: Newhouse
authors.forename: D
authors.initials: D
authors.lastname: Sack
authors.forename: E
authors.initials: E
authors.lastname: De Souza
authors.forename: C
authors.initials: C
authors.lastname: Sadowsky
authors.forename: E
authors.initials: E
authors.lastname: Roberts
mesh_terms: D000368:Aged; D017109:Akathisia, Drug-Induced / Q000209:etiology; D000544:Alzheimer Disease / Q000188:drug therapy*; D003071:Cognition / Q000187:drug effects; D003221:Confusion / Q000139:chemically induced; D003687:Dehydroepiandrosterone / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D019314:Dehydroepiandrosterone Sulfate / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use; D018697:Nootropic Agents / Q000009:adverse effects / Q000627:therapeutic use; D010259:Paranoid Disorders / Q000139:chemically induced; D010352:Patient Dropouts; D010865:Pilot Projects; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018696:Neuroprotective Agents; D018697:Nootropic Agents; D003687:Dehydroepiandrosterone; D019314:Dehydroepiandrosterone Sulfate; D006854:Hydrocortisone