Effect of Testosterone Therapy in Men With Alzheimer's Disease and Low Testosterone
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease|
- Calculated difference image of pre-treatment and on-treatment PET scans.
- Change in cognitive function at 8-week intervals over a 6-month period.
|Study Start Date:||April 2007|
|Study Completion Date:||July 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Drug: AndroGel (Solvay Pharmaceuticals)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392912
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert S. Tan, MD||Michael E. DeBakey VA Medical Center, Houston, TX|