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Completed

NCT Number: NCT00539305

Hormone and Information Processing Study

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Alzheimer's Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

VA Puget Sound Health Care Systems

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Testosterone gel

Drug

50-100mg applied topically daily for six months

Other names: Solvay Testosterone Gel

Placebo Gel

Drug

applied topically daily for six months

Primary outcomes

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

    Time frame: Baseline, 3 and 6 months

    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.

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

    Time frame: Baseline, 3 and 6 months

    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.

  3. Geriatric Depression Scale (GDS)

    Time frame: Baseline, Month 3, Month 6

    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.

  4. Short-Form Health Survey (SF-36)

    Time frame: Baseline, Month 3, Month 6

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Aging (NIA)
  • Solvay Pharmaceuticals

Registry information

Official study title

Testosterone Supplementation in Men With MCI

Acronym: HIP

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 4, 2007
Registry last updated
Jul 14, 2014

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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