NCT00392912

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Michael E. DeBakey VA Medical Center · Federal
• Sex: Male
• Age: 55 Years
• Healthy volunteers: Not accepted

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 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

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.

Conditions

• Alzheimer's Disease
• Hypogonadism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-11-01
• Completion: 2010-07-01
• First posted: 2006-10-26
• Last updated: 2010-08-19

Locations

1 site across 1 country: United States