Status:
COMPLETED
Effect of Testosterone Therapy in Men With Alzheimer's Disease and Low Testosterone
Lead Sponsor:
Michael E. DeBakey VA Medical Center
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Alzheimer's Disease
Hypogonadism
Eligibility:
MALE
55+ years
Phase:
NA
Brief Summary
Treatment with testosterone can improve performance on tests of spatial ability in men with low testosterone levels and Alzheimer's disease. Improved performance on these tests may mean an improved ab...
Detailed Description
Volunteers will be treated with a prescription testosterone gel applied to the shoulder or other body area each day. This treatment will continue for 6 months. Subjects will undergo a PET scan at the ...
Eligibility Criteria
Inclusion
- Alzheimer's disease diagnosis, based on Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V)
- Total testosterone \< 300 ng/dL and/or calculated free testosterone \< 50 pg/ml
- Sufficient English to perform cognitive testing
- Stable on concomitant medications for 1 month prior to starting study
Exclusion
- history of prostate cancer
- history of breast cancer
- gonadal endocrine disorders
- current major psychiatric illness (excluding depression)
- significant uncontrolled systemic illness
- recent myocardial infarction (within 6 months)
- renal or hepatic disease, sleep apnea
- history of alcoholism or substance abuse within the past year
- history of head injury with loss of consciousness greater than 1 hour
- testosterone or other androgen treatment within past 3 months
- history of taking other drugs that might interfere with the results of the study (ie, spironolactone, cimetidine, antiandrogens, estrogens, p450 enzyme inducers, barbiturates)
- symptomatic BPH: prostatic symptoms, prostatic masses or induration on rectal examination
- prostate specific antigen (PSA) \>4.0 mg/mL
- hemoglobin \> 17 mg/dL
- generalized skin disease that could affect the absorption of testosterone gel (ie, psoriasis).
- potentially agitated or uncooperative for procedures
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00392912
Start Date
April 1 2007
End Date
July 1 2010
Last Update
August 19 2010
Active Locations (1)
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1
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030