Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257712
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2005-11-21
Brief Title:
SMART Somatotrophics Memory and Aging Research Trial
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
GHRH Cognition in Aging and MCI
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the SMART study was to better understand whether the bodys 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
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 hormonegrowth hormoneinsulin-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 GHRHGHIGF-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
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 GHRHGHIGF-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG025525-01A1 | NIH | None | httpsreporternihgovquickSearchR01AG025525-01A1 |
| R01AG025515 | NIH | None | None |