The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
NCT ID: NCT02553603
Last Updated: 2019-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2017-07-18
2019-01-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mild Cognitive Impairment, Placebo
Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).
Placebo Growth Hormone Releasing Hormone
Placebo GHRH to be given once daily for 10 weeks
Non-cognitively impaired, Placebo
Subjects aged 55- 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).
Placebo Growth Hormone Releasing Hormone
Placebo GHRH to be given once daily for 10 weeks
Mild Cognitive Impairment, GHRH
Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).
Growth Hormone Releasing Hormone (GHRH)
Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
Non-cognitively impaired, GHRH
Subjects aged 55 - 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).
Growth Hormone Releasing Hormone (GHRH)
Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
Interventions
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Growth Hormone Releasing Hormone (GHRH)
Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
Placebo Growth Hormone Releasing Hormone
Placebo GHRH to be given once daily for 10 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
85 Years
ALL
Yes
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Randall J Urban, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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The University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Other Identifiers
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15-0086
Identifier Type: -
Identifier Source: org_study_id
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