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

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
VA Medical Center, Houston
ClinicalTrials.gov Identifier:
NCT00392912
First received: October 24, 2006
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Hypogonadism
Drug: AndroGel (Solvay Pharmaceuticals)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by VA Medical Center, Houston:

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.

Enrollment: 10
Study Start Date: April 2007
Study Completion Date: July 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: AndroGel 1% 5g packets (Solvay Pharmaceuticals)
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392912

Locations
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Medical Center, Houston
Solvay Pharmaceuticals
Investigators
Principal Investigator: Robert S. Tan, MD Michael E. DeBakey VA Medical Center, Houston, TX
  More Information

No publications provided

Responsible Party: Robert Tan, MD
ClinicalTrials.gov Identifier: NCT00392912     History of Changes
Other Study ID Numbers: GR-294
Study First Received: October 24, 2006
Last Updated: August 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by VA Medical Center, Houston:
testosterone
hypogonadal
cerebral glucose metabolism
PET scan
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Hypogonadism
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on April 17, 2014