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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00257712 |
The purpose of the SMART study is to better understand whether the body's own production of growth hormone (GH) will improve memory and problem solving ability, or cognitive function. The study is 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).
Condition | Intervention | Phase |
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Aging Mild Cognitive Impairment |
Drug: TH9507 human growth hormone releasing hormone (GHRH) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | GHRH: Cognition in Aging and MCI |
Estimated Enrollment: | 160 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: TH9507 human growth hormone releasing hormone (GHRH)
1mg subcutaneous injection given daily for 20 weeks
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2: Placebo Comparator |
Drug: TH9507 human growth hormone releasing hormone (GHRH)
1mg subcutaneous injection given daily for 20 weeks
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There is considerable and compelling evidence from both the animal and human literature that the actions of the somatotrophic hormonal axis (growth hormone releasing hormone/growth hormone/insulin-like growth factor I) have significant and predictable effects on cognitive function (memory and reasoning ability). A preliminary study has recently shown that five months of growth hormone releasing hormone (GHRH) treatment improves cognitive function in healthy older men and women; there is also preliminary evidence that supports the likelihood of a similar effect in individuals diagnosed with MCI.
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.
Ages Eligible for Study: | 55 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The following inclusion criteria will be applied to identify potential MCI participants:
The following inclusion criteria will be applied to identify potential normal control participants:
Exclusion Criteria:
Contact: Suzanne V. Barsness, RN,MSN,CCRC | 206-543-3897 | barsness@u.washington.edu |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Michael V. Vitiello, PhD 206-616-3444 vitiello@u.washington.edu | |
Contact: Suzanne Barsness, RN,MSN,CCRC 206-543-3897 barsness@u.washington.edu | |
Principal Investigator: Michael V. Vitiello, PhD | |
Sub-Investigator: Soo Borson, MD | |
Sub-Investigator: George Merriam, MD | |
Sub-Investigator: Laura Baker, PhD | |
Sub-Investigator: Suzanne Craft, PhD |
Principal Investigator: | Michael V. Vitiello, PhD | University of Washington |
Study Director: | Suzanne Barsness, RN,MSN,CCRC | University of Washington |
Responsible Party: | University of Washington ( Michael V. Vitiello, PhD ) |
Study ID Numbers: | IA0088, R01 AG025525-01 A1 |
Study First Received: | November 21, 2005 |
Last Updated: | February 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00257712 |
Health Authority: | United States: Food and Drug Administration |
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