Hormone and Information Processing Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Mild Cognitive Impairment, Alzheimer's Disease

In brief

The purpose of this study is to examine the effects of testosterone (T) replacement on changes in thinking and memory, as well as mood in older men with mild cognitive impairment (MCI) and low T levels. The study will also examine whether taking testosterone has effects on biological markers related to Alzheimer's disease.

Key facts

Study ID

NCT00539305

Run by

University of Washington

People needed

22

Starts

2009-07-01

Expected to finish

2012-05-01

Last updated by the study team

2014-07-14

Who can join

Age: 60 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male 60-90 years of age
• Diagnosis of mild cognitive impairment (MCI)
• Low testosterone level
• Primary language is English
• Availability of an informant who knows the participant well enough to answer questions
• Stable medications for the previous 3 months
• Normal complete blood count (CBC), and no clinically significant blood chemistry
• American Urological Association (AUA) symptom score less than or equal to 19
• Body Mass Index (BMI) less than 33 and stable weight in the previous year

You may not qualify if…

• Prior history of prostate cancer or prostate specific antigen level greater than 4.0ng/ml
• Peripheral or vascular disease
• Significant history of alcohol abuse, current alcohol abuse (more than 2 drinks per day), or other substance abuse
• History of severe head injury (with loss of consciousness greater than 30 minutes)
• Significant neurological illness, such as Parkinson's disease, seizure disorder, multiple sclerosis, major stoke
• Smokes cigarettes
• Major psychiatric illness, such as schizophrenia or bipolar disorder
• Prohibited Medications:
• Anti-convulsants
• Anti-psychotics
• Sedating antihistamines
• Sedative/hypnotics
• Benzodiazepines
• Hormone or testosterone regimens
• Gonadotropin-releasing hormone (GNRH) antagonists
• Flutamide
• Anti-depressants and/or anti-cholinesterase inhibitors, but acceptable if on stable dose for 3 months or more

Where it is running

• VA Puget Sound Health Care Systems — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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