Hormone and Information Processing Study - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	Related Studies

Hormone and Information Processing Study (HIP)

This study is currently recruiting participants.
Information provided by National Institute on Aging (NIA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Hormone and Information Processing Study

Official Title ^†

Testosterone Supplementation in Men With MCI

Brief 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.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Behavioral & Mood measure: Profile of Mood States (POMS) [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
Cognitive changes measured by Neuropsychological tests: ADAS-Cog (MCI version), Route Test, Paragraph recall [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
Cerebrospinal Fluid (CSF) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
APOE genotyping [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Condition ^†

Mild Cognitive Impairment
Alzheimer's Disease

Intervention ^†

Drug: testosterone gel
Drug: placebo gel

MEDLINE PMIDs

11445632, 15668427, 15985573, 17145137, 16344336

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

April 2007

Completion Date

March 2010

Eligibility 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), calcium, albumin, TSH, 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
GNRH antagonists
Flutamide
Anti-depressants and/or anti-cholinesterase inhibitors, but acceptable if on stable dose for 3 months or more

Gender

Male

Ages

60 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Christina Bradic	206-277-1155	cb80@u.washington.edu
Contact: Gareth Holman	206-277-5055	gholman@u.washington.edu

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00539305

Organization ID

IA0124

Secondary IDs ^††

1R01AG027156-01 A2

Study Sponsor ^†

National Institute on Aging (NIA)

Collaborators ^††

Solvay Pharmaceuticals

Investigators ^†

Principal Investigator:

Monique Cherrier, PhD

University of Washington

Information Provided By

National Institute on Aging (NIA)

Verification Date

February 2008

First Received Date ^†

October 3, 2007

Last Updated Date

February 25, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.