Mild Cognitive Impairment Clinical Trial
Official title:
Testosterone Supplementation in Men With MCI
The purpose of this study is to examine the effects of testosterone (T) replacement on changes in thinking and memory, as well as mood in older men with mild cognitive impairment (MCI) and low T levels. The study will also examine whether taking testosterone has effects on biological markers related to Alzheimer's disease.
Natural age related declines in testosterone (T) are associated with decreases in cognitive
abilities independent of health status. Low T levels over time are associated with increased
risk for developing Alzheimer's disease (AD). These findings suggest that men with low T
levels are most at risk for age-related cognitive decline and AD and therefore most likely
to benefit from T supplementation to prevent the development of AD or age-associated
cognitive decline. The current study will assess cognition, mood, and cerebral spinal fluid
(CSF) biomarker response to T supplementation in older men with mild cognitive impairment
(MCI) and low T levels.
Participants will be randomized to either receive T treatment or a placebo for six months.
Participants will come in for about five visits within the span of six months where they
will complete cognitive & memory tests, fill out mood questionnaires, and have their blood
drawn to monitor the medication level. A sample of blood will also be taken at one visit to
test for apolipoprotein E (APOE), which is a genetic risk factor associated with AD.
Participants will have the option to get a spinal tap in order to measure biological markers
associated with Alzheimer's disease including beta-amyloid 1-40, 42, total-tau, and
phosphorylated-tau-181-231. This will require an additional two visits.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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