Testosterone replacement therapy in older male subjective memory complainers:
double-blind randomized crossover placebo-controlled clinical trial of
physiological assessment and safety.
Author(s): Asih PR, Wahjoepramono EJ, Aniwiyanti V, Wijaya LK, de Ruyck K, Taddei K, Fuller
SJ, Sohrabi H, Dhaliwal SS, Verdile G, Carruthers M, Martins RN(1).
Affiliation(s): Author information:
(1)Edith Cowan University, Suite 22, Hollywood Medical Centre, 85 Monash Avenue,
Nedlands, WA 6009, Australia. r.martins@ecu.edu.au.
Publication date & source: 2015, CNS Neurol Disord Drug Targets. , 14(5):576-86
Testosterone replacement therapy (TRT) has been investigated in older men as a
preventative treatment against Alzheimer's disease and dementia. However,
previous studies have been contradictory. We assessed TRT physiological effects
in 44 older men (aged 61 ± 7.7 years) with subjective memory complaints using a
double blind, randomized, crossover, placebo-controlled study. Participants were
randomized into 2 groups, one group received transdermal testosterone (50 mg)
daily for 24 weeks, followed by a 4 week wash-out period, then 24 weeks of
placebo; the other group received the reverse treatment. Blood evaluation
revealed significant increases in total testosterone, free (calculated)
testosterone, dihydrotestosterone, and a decrease in luteinizing hormone levels
(p<0.001) following TRT. Although there were significant increases in red blood
cell counts, hemoglobin and prostate specific antigen levels following TRT, they
remained within normal ranges. No significant differences in plasma amyloid beta,
estradiol, sex hormone binding globulin, insulin levels, body fat percentage, or
body mass index were detected. This is the first carefully controlled study that
has investigated the influence of TRT in Indonesian men on blood biomarkers
linked to dementia risk. Our study suggests TRT is safe and well-tolerated in
this Indonesian cohort, yet longitudinal studies with larger cohorts are needed
to assess TRT further, and to establish whether TRT reduces dementia risk.
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