Mild Cognitive Impairment
Conditions
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.
Interventions
DRUGGrowth Hormone Releasing Hormone (GHRH)
Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
DRUGPlacebo Growth Hormone Releasing Hormone
Placebo GHRH to be given once daily for 10 weeks
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed