Mild Cognitive Impairment Clinical Trial
Official title:
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Verified date | October 2019 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls.
Status | Completed |
Enrollment | 22 |
Est. completion date | January 17, 2019 |
Est. primary completion date | January 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Age = 55 to = 85 years - Ability to sign consent form (score = on the Mini Mental State Examination, MMSE) - MCI group: MMSE scores of 23 - 26 - Normal Control Group: MMSE scores of 27 - 30 Exclusion Criteria: - Diabetes - A neurologic condition other than MCI which might cause cognitive impairment - Baseline serum IGF-1 concentration greater than the midrange for healthy young adults (300ng/ml) - Presence of a pacemaker or metal implant - Heart Failure - Edema - Active malignancy - Carpal tunnel syndrome - Disruption of the hypothalamic pituitary axis such that the pituitary is expected to be insensitive to growth hormone secretagogues such as GHRH - Known allergy to tesamorelin or mannitol - Pregnancy - Significant heart, liver, kidney, blood or respiratory disease - Active cancer - Recent (within 6 months) treatment with anabolic steroids, GHRH or corticosteroids - Alcohol or drug abuse - MMSE < 23 - Less than 12 years of education - Significant findings on screening tests, including but not limited to, blood counts, blood biochemistries, urinalysis, drug screening, HIV test, hepatitis panel, electrocardiogram - Other medical conditions deemed exclusionary by the study investigators |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Medical Branch | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive Function measured by SLUMS | Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS) | 10 weeks | |
Primary | Brain Perfusion measured by fMRI | Brain Perfusion at 10 week measured by MRI | 10 weeks | |
Primary | Brain Morphology measured by MRI | Brain Morphology at 10 weeks measured by MRI | 10 weeks | |
Secondary | Body composition measured by DEXA | Body composition at 10 weeks measured by DEXA | 10 weeks | |
Secondary | Physical Function measured by 6 minute walking test | Physical Function at 10 weeks measured by 6 minute walking test | 10 weeks |
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