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Completed

NCT Number: NCT00392912

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Endocrine System Diseases Gonadal Disorders Hypogonadism Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AndroGel (Solvay Pharmaceuticals)

Drug

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 names: AndroGel 1% 5g packets (Solvay Pharmaceuticals)

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Michael E. DeBakey VA Medical Center

Fed

Collaborators

  • Solvay Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Oct 26, 2006
Registry last updated
Aug 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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