DRUG
Growth Hormone Releasing Hormone (GHRH)
Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Status
Completed
Phase
Phase 1
Enrollment
22
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Full detailed description
Subjects with MCI as well as healthy controls will be given GHRH at a dose of 1mg/day for 10 weeks. This study is designed to investigate the effects of GHRH on the following things: 1) cognitive function as measured by our neuropsychologist with a series of short tests; 2) brain activity as measured by fMRI 3) lean and fat mass of your body as measured by DEXA; 4) physical function as measured by a walking test.
Interventions
Treatment arms and agents.
DRUG
Placebo Growth Hormone Releasing Hormone
Placebo GHRH to be given once daily for 10 weeks
Timeline
From registration to results.
First posted
Sep 17, 2015
Study start
Jul 18, 2017
Primary completion
Jan 17, 2019
Study completion
Jan 17, 2019
Results posted
Not reported
Registry updated
Nov 4, 2019
Outcomes
What the study measures.
Primary outcomes
Cognitive Function measured by SLUMS
Time frame · 10 weeks
Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)
Brain Perfusion measured by fMRI
Time frame · 10 weeks
Brain Perfusion at 10 week measured by MRI
Brain Morphology measured by MRI
Time frame · 10 weeks
Brain Morphology at 10 weeks measured by MRI
Secondary outcomes
Body composition measured by DEXA
Time frame · 10 weeks
Body composition at 10 weeks measured by DEXA
Physical Function measured by 6 minute walking test
Time frame · 10 weeks
Physical Function at 10 weeks measured by 6 minute walking test
Eligibility
Who can take part.
- Minimum age
- 55 Years
- Maximum age
- 85 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
The University of Texas Medical Branch
Galveston, Texas, United States
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