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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 21, 2005 | ||||||||
| Last Updated Date | January 29, 2009 | ||||||||
| Start Date ICMJE | February 2006 | ||||||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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. | ||||||||
| Change History | Complete list of historical versions of study NCT00257712 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
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. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | SMART: Somatotrophics, Memory, and Aging Research Trial | ||||||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: TH9507 human growth hormone releasing hormone (GHRH) | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 160 | ||||||||
| Estimated Completion Date | February 2012 | ||||||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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 ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00257712 | ||||||||
| Responsible Party | Michael V. Vitiello, PhD, University of Washington | ||||||||
| Study ID Numbers ICMJE | IA0088, R01 AG025525-01 A1 | ||||||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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