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

Primary Purpose

Alzheimer's Disease, Hypogonadism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AndroGel (Solvay Pharmaceuticals)
Sponsored by
Michael E. DeBakey VA Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring testosterone, hypogonadal, cerebral glucose metabolism, PET scan, Alzheimer's disease

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Michael E. DeBakey VA Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 24, 2006
Last Updated
August 18, 2010
Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00392912
Brief Title
Effect of Testosterone Therapy in Men With Alzheimer's Disease and Low Testosterone
Official Title
A Pilot Study of the Effect of Testosterone on Cerebral Glucose Metabolism in Hypogonadal Males With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Hypogonadism
Keywords
testosterone, hypogonadal, cerebral glucose metabolism, PET scan, Alzheimer's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AndroGel (Solvay Pharmaceuticals)
Other Intervention Name(s)
AndroGel 1% 5g packets (Solvay Pharmaceuticals)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Calculated difference image of pre-treatment and on-treatment PET scans.
Secondary Outcome Measure Information:
Title
Change in cognitive function at 8-week intervals over a 6-month period.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S. Tan, MD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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