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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392912
• Other study ID #: GR-294
• Status: Completed
• Phase: N/A
• First received: October 24, 2006
• Last updated: August 18, 2010
• Start date: April 2007
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: VA Medical Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Hypogonadism

Intervention

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.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
VA Medical Center, Houston	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated difference image of pre-treatment and on-treatment PET scans.
Secondary	Change in cognitive function at 8-week intervals over a 6-month period.