The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Interventions
- Drug: Growth Hormone Releasing Hormone (GHRH)Drug: Placebo Growth Hormone Releasing Hormone
- Registration Number
- NCT02553603
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-cognitively impaired, GHRH Growth Hormone Releasing Hormone (GHRH) Subjects aged 55 - 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH). Mild Cognitive Impairment, GHRH Growth Hormone Releasing Hormone (GHRH) Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH). Mild Cognitive Impairment, Placebo Placebo Growth Hormone Releasing Hormone Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH). Non-cognitively impaired, Placebo Placebo Growth Hormone Releasing Hormone Subjects aged 55- 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).
- Primary Outcome Measures
Name Time Method Cognitive Function measured by SLUMS 10 weeks Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)
Brain Perfusion measured by fMRI 10 weeks Brain Perfusion at 10 week measured by MRI
Brain Morphology measured by MRI 10 weeks Brain Morphology at 10 weeks measured by MRI
- Secondary Outcome Measures
Name Time Method Body composition measured by DEXA 10 weeks Body composition at 10 weeks measured by DEXA
Physical Function measured by 6 minute walking test 10 weeks Physical Function at 10 weeks measured by 6 minute walking test
Trial Locations
- Locations (1)
The University of Texas Medical Branch
🇺🇸Galveston, Texas, United States