Effect of Testosterone Therapy in Men With Alzheimer's Disease and Low Testosterone

Study Overview
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Brief Summary
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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 ability to get around in one's environment without getting lost or injured. This could have a positive impact on both patients and those who care for them. We will investigate what areas of the brain are involved in these improvements in spatial ability. This will be done using a PET scan, which creates a 3-dimensional image of the brain that can allow us to see how the brain functions.

Detailed Description
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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 beginning of the study and after approximately 2 months of treatment. Subjects will undergo some cognitive testing throughout the study.

Official Title
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A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease

Conditions
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Alzheimer's Disease, Hypogonadism

Intervention / Treatment
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* Drug: AndroGel (Solvay Pharmaceuticals)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AndroGel (Solvay Pharmaceuticals)|Testosterone Replacement Therapy: AndroGel 1% 5g packets (Solvay Pharmaceuticals). Initial dosage: 5g daily (1 packet). Patients who do not achieve eugonadal levels of 400-600 mg/dL within 2 weeks will be raised to 10g daily.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated difference image of pre-treatment and on-treatment PET scans. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function at 8-week intervals over a 6-month period. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testosterone, hypogonadal, cerebral glucose metabolism, PET scan, Alzheimer's disease