SMART: Somatotrophics, Memory, and Aging Research Trial
NCT ID: NCT00257712
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
151 participants
INTERVENTIONAL
2006-02-28
2011-12-31
Brief Summary
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Detailed Description
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The study sample will include 160 adults, ages 55-90, half of whom will be cognitively healthy normal adults and half of whom will meet diagnostic criteria for Mild Cognitive Impairment (MCI). Each of these groups will contain equal numbers of men and women. The treatment with GHRH will be twenty weeks in duration. In light of the documented interactions between estrogens and GHRH/GH/IGF-I, each of the two study arms will contain equal proportions of women not on estrogen replacement therapy (NERT) and women on oral estrogen replacement therapy (ERT). ERT women will maintain a regular steady dosage of estrogens for at least seven days preceding each assessment
Cognitive assessments to evaluate treatment-related changes in memory and thinking abilities, as well as blood collection to evaluate several biomarkers of interest, will be performed at baseline, 10 and 20 weeks of treatment, and ten weeks post-treatment. In addition there will be five medication and symptom monitoring visits during the treatment period.
The study hypotheses are:
H1: Healthy, cognitively normal older men and women treated with GHRH will show beneficial effects in cognitive function, including measures of memory, relative to placebo treated subjects.
H2: MCI patients treated with GHRH will show beneficial effects in cognitive function, including measures of memory, relative to placebo treated MCI patients.
H3: Changes in insulin-like-growth factor (IGF-I) will predict changes in cognition both for normal older adults and for MCI patients treated with GHRH.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
TH9507 human growth hormone releasing hormone (GHRH)
1mg subcutaneous injection given daily for 20 weeks
2
TH9507 human growth hormone releasing hormone (GHRH)
1mg subcutaneous injection given daily for 20 weeks
Interventions
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TH9507 human growth hormone releasing hormone (GHRH)
1mg subcutaneous injection given daily for 20 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* Memory complaint that can be corroborated by a study partner
* Memory test scores meeting the diagnostic criteria for MCI
* MMSE score greater than 20
* Cognitive testing does not indicate MCI
* MMSE score greater than 28
Exclusion Criteria
* 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
55 Years
90 Years
ALL
Yes
Sponsors
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University of Washington
OTHER
National Institute on Aging (NIA)
NIH
Responsible Party
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Michael Vitiello
PhD, Professor
Principal Investigators
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Michael V. Vitiello, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Suzanne Barsness, RN,MSN,CCRC
Role: STUDY_DIRECTOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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References
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Merriam GR, Schwartz RS, Vitiello MV. Growth hormone-releasing hormone and growth hormone secretagogues in normal aging. Endocrine. 2003 Oct;22(1):41-8. doi: 10.1385/ENDO:22:1:41.
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. doi: 10.1016/j.neurobiolaging.2005.01.010. Epub 2005 Mar 23.
Friedman SD, Baker LD, Borson S, Jensen JE, Barsness SM, Craft S, Merriam GR, Otto RK, Novotny EJ, Vitiello MV. Growth hormone-releasing hormone effects on brain gamma-aminobutyric acid levels in mild cognitive impairment and healthy aging. JAMA Neurol. 2013 Jul;70(7):883-90. doi: 10.1001/jamaneurol.2013.1425.
Baker LD, Barsness SM, Borson S, Merriam GR, Friedman SD, Craft S, Vitiello MV. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Arch Neurol. 2012 Nov;69(11):1420-9. doi: 10.1001/archneurol.2012.1970.
Other Identifiers
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