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Sponsors and Collaborators: |
VA Medical Center, Houston Solvay Pharmaceuticals |
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Information provided by: | VA Medical Center, Houston |
ClinicalTrials.gov Identifier: | NCT00392912 |
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.
Condition | Intervention |
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Alzheimer's Disease Hypogonadism |
Drug: Testosterone replacement therapy: AndroGel 1% 5g packets (Solvay Pharmaceuticals) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease |
Estimated Enrollment: | 12 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert S. Tan, MD | 713-794-7382 | Robert.Tan@med.va.gov |
Contact: Maurita Carrejo, MS | 713-794-8766 | Maurita.Carrejo@med.va.gov |
United States, Texas | |
Michael E. DeBakey VA Medical Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Maurita Carrejo, MS 713-794-8766 Maurita.Carrejo@med.va.gov |
Principal Investigator: | Robert S. Tan, MD | Michael E. DeBakey VA Medical Center, Houston, TX |
Responsible Party: | ( Robert Tan, MD ) |
Study ID Numbers: | GR-294 |
Study First Received: | October 24, 2006 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00392912 |
Health Authority: | United States: Institutional Review Board |
testosterone hypogonadal cerebral glucose metabolism PET scan Alzheimer's disease |
Gonadal Disorders Alzheimer Disease Central Nervous System Diseases Endocrine System Diseases Methyltestosterone Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Testosterone 17 beta-cypionate Testosterone Hypogonadism Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Endocrinopathy Dementia Delirium |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Hormones, Hormone Substitutes, and Hormone Antagonists Tauopathies Hormones Pharmacologic Actions Androgens |