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Sponsors and Collaborators: |
National Institute on Aging (NIA) Solvay Pharmaceuticals |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00539305 |
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.
Condition | Intervention | Phase |
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Mild Cognitive Impairment Alzheimer's Disease |
Drug: testosterone gel Drug: placebo gel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Testosterone Supplementation in Men With MCI |
Estimated Enrollment: | 60 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
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Drug: testosterone gel
50-100mg applied topically daily for six months
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2: Placebo Comparator |
Drug: placebo gel
applied topically daily for six months
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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.
Ages Eligible for Study: | 60 Years to 90 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prohibited Medications:
Contact: Christina Bradic | 206-277-1155 | cb80@u.washington.edu |
Contact: Gareth Holman | 206-277-5055 | gholman@u.washington.edu |
United States, Washington | |
VA Puget Sound Health Care Systems | Recruiting |
Seattle, Washington, United States, 98108 |
Principal Investigator: | Monique Cherrier, PhD | University of Washington |
Responsible Party: | University of Washington ( Monique Cherrier, PhD ) |
Study ID Numbers: | IA0124, 1R01AG027156-01 A2 |
Study First Received: | October 3, 2007 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00539305 History of Changes |
Health Authority: | United States: Federal Government |
selective androgen receptor modulators (SARMs) hormone replacement therapy age-associated cognitive decline testosterone supplementation |
Antineoplastic Agents, Hormonal Hormone Antagonists Alzheimer Disease Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Diseases Methyltestosterone Brain Diseases Neurodegenerative Diseases Hormones |
Cognition Disorders Testosterone 17 beta-cypionate Anabolic Agents Testosterone Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Androgens Delirium |
Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Diseases Methyltestosterone Brain Diseases Neurodegenerative Diseases Hormones |
Pharmacologic Actions Cognition Disorders Testosterone 17 beta-cypionate Anabolic Agents Testosterone Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Dementia Tauopathies Androgens |