Testosterone Treatment and Cognitive Function in Older Men With Low Testosterone and Age-Associated Memory Impairment
Abstract
IMPORTANCE: Most cognitive functions decline with age. Prior studies suggest that testosterone treatment may improve these functions.
OBJECTIVE: To determine if testosterone treatment compared with placebo is associated with improved verbal memory and other cognitive functions in older men with low testosterone and age-associated memory impairment (AAMI).
DESIGN, SETTING, AND PARTICIPANTS: The Testosterone Trials (TTrials) were 7 trials to assess the efficacy of testosterone treatment in older men with low testosterone levels. The Cognitive Function Trial evaluated cognitive function in all TTrials participants. In 12 US academic medical centers, 788 men who were 65 years or older with a serum testosterone level less than 275 ng/mL and impaired sexual function, physical function, or vitality were allocated to testosterone treatment (n = 394) or placebo (n = 394). A subgroup of 493 men met criteria for AAMI based on baseline subjective memory complaints and objective memory performance. Enrollment in the TTrials began June 24, 2010; the final participant completed treatment and assessment in June 2014.
INTERVENTIONS: Testosterone gel (adjusted to maintain the testosterone level within the normal range for young men) or placebo gel for 1 year.
MAIN OUTCOMES AND MEASURES: The primary outcome was the mean change from baseline to 6 months and 12 months for delayed paragraph recall (score range, 0 to 50) among men with AAMI. Secondary outcomes were mean changes in visual memory…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 788 participants or records.
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