Hormone and Information Processing Study

University of Washington22 enrolled

Overview

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.

Natural age related declines in testosterone (T) are associated with decreases in cognitive abilities independent of health status. Low T levels over time are associated with increased risk for developing Alzheimer's disease (AD). These findings suggest that men with low T levels are most at risk for age-related cognitive decline and AD and therefore most likely to benefit from T supplementation to prevent the development of AD or age-associated cognitive decline. The current study will assess cognition, mood, and cerebral spinal fluid (CSF) biomarker response to T supplementation in older men with mild cognitive impairment (MCI) and low T levels. Participants will be randomized to either receive T treatment or a placebo for six months. Participants will come in for about five visits within the span of six months where they will complete cognitive \& memory tests, fill out mood questionnaires, and have their blood drawn to monitor the medication level. A sample of blood will also be taken at one visit to test for apolipoprotein E (APOE), which is a genetic risk factor associated with AD. Participants will have the option to get a spinal tap in order to measure biological markers associated with Alzheimer's disease including beta-amyloid 1-40, 42, total-tau, and phosphorylated-tau-181-231. This will require an additional two visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Mild Cognitive Impairment Alzheimer's Disease

Interventions

testosterone gelDRUG

50-100mg applied topically daily for six months

placebo gelDRUG

applied topically daily for six months

Eligibility

Sex: MALEMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

VA Puget Sound Health Care Systems

Seattle, Washington, United States

Outcomes

Primary Outcomes

Behavioral & Mood Measure: Profile of Mood States (POMS)

Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.

Time frame: Baseline, 3 and 6 months

Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test

Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline.

Time frame: Baseline, 3 and 6 months

Geriatric Depression Scale (GDS)

Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline.

Time frame: Baseline, Month 3, Month 6

Short-Form Health Survey (SF-36)

Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale.

Time frame: Baseline, Month 3, Month 6

Data from ClinicalTrials.gov

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