Hormone and Information Processing Study

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: National Institute on Aging (NIA); Solvay Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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