At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 22 enrolled
Drug / intervention
testosterone gel +1 moredrug
Likely dose
testosterone gel 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Testosterone Supplementation in Men With MCI
In Brief
A Phase 3 clinical trial evaluating testosterone gel and placebo gel for Mild Cognitive Impairment and Alzheimer's Disease. Completed, enrolled 22 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment, Alzheimer's Disease
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA), Solvay Pharmaceuticals
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartJul 2009
Primary CompletionJul 2011
Study CompletionMay 2012
TodayJul 2026
First PostedOct 4, 2007
Enrollment StartJul 1, 2009
Primary CompletionJul 1, 2011
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.7 years ago
Interventions
testosterone geldrug
50-100mg applied topically daily for six months
placebo geldrug
applied topically daily for six months