Aging Clinical Trial
Official title:
GHRH: Cognition in Aging and MCI
Verified date | December 2013 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the SMART study was to better understand whether the body's own production of growth hormone (GH) would improve memory and problem solving ability, or cognitive function. The study was a double blind, placebo-controlled study of the cognitive effects of growth hormone releasing hormone (GHRH) in healthy older men and women and in those with mild cognitive impairment (MCI).
Status | Completed |
Enrollment | 151 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Able to give and understand informed consent - Able to communicate in English - No exclusionary criteria apply - Age between 55 and 90 years - Independent in their daily living abilities - Living at home with a reliable spouse, significant other or caregiver - Normal PSA (for men) or mammogram (for women) within one year of study entry The following inclusion criteria will be applied to identify potential MCI participants: - Memory complaint that can be corroborated by a study partner - Memory test scores meeting the diagnostic criteria for MCI - MMSE score greater than 20 The following inclusion criteria will be applied to identify potential normal control participants: - Cognitive testing does not indicate MCI - MMSE score greater than 28 Exclusion Criteria: - Use of medications known to affect the GHRH/GH/IGF-I axis, including transdermal estrogens (use of oral estrogens is not contraindicated) - Significant medical illness or organ failure, such as uncontrolled hypertension, diabetes, cardiac disease, cerebrovascular disease, chronic obstructive pulmonary disease, kidney and liver disease - Significant neurologic disease that might affect cognition, such as Alzheimer's disease, stroke, Parkinson's disease, multiple sclerosis, severe head injury with loss of consciousness for more than 30 minutes or with permanent neurologic sequelae - Personal or strong family history of cancer (especially colon, breast or melanoma) - Evidence for pituitary disease by history or physical examination - Symptoms or history of carpal tunnel or a positive Phalen's Test - Active arthritis - Significant current psychiatric illness, such as depression, schizophrenia or an Axis II diagnosis suggestive of an inability to successfully complete the study protocol - Current use of an anti-psychotic, anti-depressant, anti-convulsant, anti-coagulant, anxiolytic or sedative - Current or planned use of DHEA, testosterone or cognition-enhancing medication (e.g., cholinesterase inhibitors, memantine) - Weight greater than 150% ideal body weight - Tobacco use, excessive alcohol intake (more than 2 drinks per day), excessive caffeine intake (more than 4 cups of coffee per day) - Baseline IGF-I level greater than the mid-range for healthy young adults (250 ng/ml) - Meets NINCDS/ADRDA criteria for AD |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute on Aging (NIA) |
United States,
Merriam GR, Schwartz RS, Vitiello MV. Growth hormone-releasing hormone and growth hormone secretagogues in normal aging. Endocrine. 2003 Oct;22(1):41-8. Review. — View Citation
Vitiello MV, Moe KE, Merriam GR, Mazzoni G, Buchner DH, Schwartz RS. Growth hormone releasing hormone improves the cognition of healthy older adults. Neurobiol Aging. 2006 Feb;27(2):318-23. Epub 2005 Mar 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in declarative memory, including total recall scores on three tests of memory and on dual task response time (RT), a test of executive function. | Baseline, 10, 20, and 30 weeks | ||
Secondary | Changes in other areas of cognitive function, including other tests of executive function, tests of lexical access, and tests of cognitive and perceptual-motor processing speed. | Baseline, 10, 20, and 30 weeks |
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