The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment

Registered clinical trial record on ClinicalTrials.gov (NCT02553603). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: completed. Study type: interventional. Phase: Phase 1. Sponsor: The University of Texas Medical Branch, Galveston. Conditions: Mild Cognitive Impairment. Interventions: Growth Hormone Releasing Hormone (GHRH), Placebo Growth Hormone Releasing Hormone. 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. 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. Primary outcome measures: Cognitive Function measured by SLUMS; Brain Perfusion measured by fMRI; Brain Morphology measured by MRI. Eligibility: 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