CompletedPhase NA

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

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

Lead sponsor

Michael E. DeBakey VA Medical Center

Asset

Testosterone gel

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

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

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDGR-294

NCT IDNCT00392912

Timeline

Milestones

Study first posted2006-10-26estimated

Study start2007-04 (month precision)

Primary completion2009-11actual (month precision)

Study completion2010-07actual (month precision)

Last update posted2010-08-19estimated

Assets

Drug assets

Testosterone gel

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexMale

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Global cognition

1 endpoint

Secondary/protocol endpoint

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

change from baseline, improvement

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

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

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.