Hormone and Information Processing Study (HIP)

This study has been completed.
Sponsor:
Collaborators:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Monique Cherrier, University of Washington
ClinicalTrials.gov Identifier:
NCT00539305
First received: October 3, 2007
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Alzheimer's Disease
Drug: testosterone gel
Drug: placebo gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testosterone Supplementation in Men With MCI

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Behavioral & Mood Measure: Profile of Mood States (POMS) [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    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.

  • Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    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.

  • Geriatric Depression Scale (GDS) [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Short-Form Health Survey (SF-36) [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: July 2009
Study Completion Date: May 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study drug; testosterone transdermal gel
Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl
Drug: testosterone gel
50-100mg applied topically daily for six months
Other Name: Solvay Testosterone Gel
Placebo Comparator: 2 Drug: placebo gel
applied topically daily for six months

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539305

Locations
United States, Washington
VA Puget Sound Health Care Systems
Seattle, Washington, United States, 98108
Sponsors and Collaborators
University of Washington
Solvay Pharmaceuticals
Investigators
Principal Investigator: Monique Cherrier, PhD University of Washington
  More Information

Publications:
Responsible Party: Monique Cherrier, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00539305     History of Changes
Other Study ID Numbers: 29975-A, R01AG027156, 1R01AG027156-01 A2
Study First Received: October 3, 2007
Results First Received: March 15, 2013
Last Updated: July 10, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
selective androgen receptor modulators (SARMs)
hormone replacement therapy
age-associated cognitive decline
testosterone supplementation

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on October 01, 2014