Clinical Question: Does testosterone improve quality of life or cognitive function in men with Alzheimer’s disease?
Setting: Outpatient (specialty)
Study Design: Randomized controlled trial (double-blinded)
Synopsis: In this 24-week study, 18 men with Alzheimer’s disease and with a Mini-Mental State Examination score of 15 or higher and 29 healthy volunteers were assigned randomly to receive placebo or 75 mg of 1% hydroalcoholic dermal testosterone gel (AndroGel). The research team evaluated the patients at baseline, four weeks, 12 weeks, and 24 weeks. The main outcomes of quality of life and cognition were assessed via intention to treat with incomplete follow-up. The authors evaluated only the 22 healthy volunteers and the 16 patients with Alzheimer’s disease who completed the study.
At the end of the study, there was no significant difference in cognition. Among the quality-of-life measures, only those reported by caregivers had improved; self-reported quality-of-life was not improved. The quality-of-life improvement reported by care-givers was statistically significant but not clinically important. The authors did not report sample-size estimates or how much (or little) power they had. A study of this size would have been able to find only large differences in the outcomes measured. The authors were positive about the study findings despite the above-mentioned limitations.
Bottom Line: In this small study, testosterone supplementation had negligible effects in men with Alzheimer’s disease. (Level of Evidence: 2b)