Hormone and Information Processing Study (HIP)
|Mild Cognitive Impairment Alzheimer's Disease||Drug: testosterone gel Drug: placebo gel||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]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 ]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 ]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 ]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|