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| Descriptive Information Fields | |||||||||
| Brief Title † | SMART: Somatotrophics, Memory, and Aging Research Trial | ||||||||
| Official Title † | GHRH: Cognition in Aging and MCI | ||||||||
| Brief Summary | 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). |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | 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. [ Time Frame: Baseline, 10, 20, and 30 weeks ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | 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. [ Time Frame: Baseline, 10, 20, and 30 weeks ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Aging Mild Cognitive Impairment |
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| Intervention † | Drug: TH9507 human growth hormone releasing hormone (GHRH) | ||||||||
| MEDLINE PMIDs | 14610297, 16399214 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 160 | ||||||||
| Start Date † | February 2006 | ||||||||
| Completion Date | February 2012 | ||||||||
| Eligibility Criteria † | 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:
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| Gender | Both | ||||||||
| Ages | 55 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00257712 | ||||||||
| Organization ID | IA0088 | ||||||||
| Secondary IDs †† | R01 AG025525-01 A1 | ||||||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | November 21, 2005 | ||||||||
| Last Updated Date | February 28, 2008 | ||||||||