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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392912
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : August 19, 2010
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Michael E. DeBakey VA Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Hypogonadism Drug: AndroGel (Solvay Pharmaceuticals) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)

Outcome Measures
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Primary Outcome Measures :
  1. Calculated difference image of pre-treatment and on-treatment PET scans.

Secondary Outcome Measures :
  1. Change in cognitive function at 8-week intervals over a 6-month period.

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392912


Locations
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United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Michael E. DeBakey VA Medical Center
Solvay Pharmaceuticals
Investigators
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Principal Investigator: Robert S. Tan, MD Michael E. DeBakey VA Medical Center, Houston, TX
More Information
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Responsible Party: Robert Tan, MD
ClinicalTrials.gov Identifier: NCT00392912    
Other Study ID Numbers: GR-294
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: August 19, 2010
Last Verified: August 2010
Keywords provided by Michael E. DeBakey VA Medical Center:
testosterone
hypogonadal
cerebral glucose metabolism
PET scan
Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Hypogonadism
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Gonadal Disorders
Endocrine System Diseases
 Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents