Hormone and Information Processing Study (HIP)
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.
Mild Cognitive Impairment
Drug: testosterone gel
Drug: placebo gel
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Testosterone Supplementation in Men With MCI|
- Behavioral & Mood Measure: Profile of Mood States (POMS) [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.
- Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline.
- Geriatric Depression Scale (GDS) [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline.
- Short-Form Health Survey (SF-36) [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale.
|Study Start Date:||July 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Study drug; testosterone transdermal gel
Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
Drug: testosterone gel
50-100mg applied topically daily for six months
Other Name: Solvay Testosterone Gel
|Placebo Comparator: 2||
Drug: placebo gel
applied topically daily for six months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539305
|United States, Washington|
|VA Puget Sound Health Care Systems|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Monique Cherrier, PhD||University of Washington|