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

August 18, 2010 updated by: Michael E. DeBakey VA Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Calculated difference image of pre-treatment and on-treatment PET scans.

Secondary Outcome Measures

Outcome Measure
Change in cognitive function at 8-week intervals over a 6-month period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael E. DeBakey VA Medical Center

Collaborators

Solvay Pharmaceuticals

Investigators

  • Principal Investigator: Robert S. Tan, MD, Michael E. DeBakey VA Medical Center, Houston, TX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Estimate)

August 19, 2010

Last Update Submitted That Met QC Criteria

August 18, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-294

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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