The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Cognitive Function measured by SLUMS
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 55 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
- •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
Arms & Interventions
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).
Intervention: Growth Hormone Releasing Hormone (GHRH) (Drug)
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).
Intervention: Growth Hormone Releasing Hormone (GHRH) (Drug)
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).
Intervention: Placebo Growth Hormone Releasing Hormone (Drug)
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).
Intervention: Placebo Growth Hormone Releasing Hormone (Drug)
Outcomes
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(10 weeks)
- Physical Function measured by 6 minute walking test(10 weeks)