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| Name | Class |
|---|---|
| Solvay Pharmaceuticals | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AndroGel (Solvay Pharmaceuticals) | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calculated difference image of pre-treatment and on-treatment PET scans. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function at 8-week intervals over a 6-month period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S. Tan, MD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 29, 2013 | |
| Reset | Mar 4, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 29, 2013 | Mar 4, 2013 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |