DHEA treatment of Alzheimer's disease: a randomized, double-blind, placebo-controlled study.
Neurology
; 60(7): 1071-6, 2003 Apr 08.
Article
en En
| MEDLINE
| ID: mdl-12682308
ABSTRACT
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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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Deshidroepiandrosterona
/
Enfermedad de Alzheimer
Tipo de estudio:
Clinical_trials
/
Etiology_studies
Límite:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Neurology
Año:
2003
Tipo del documento:
Article
País de afiliación:
Estados Unidos