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

The University of Texas Medical Branch, Galveston22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Mild Cognitive Impairment

Interventions

Growth Hormone Releasing Hormone (GHRH)DRUG

Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks

Placebo Growth Hormone Releasing HormoneDRUG

Placebo GHRH to be given once daily for 10 weeks

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Medical Branch

Galveston, Texas, United States

Outcomes

Primary Outcomes

Cognitive Function measured by SLUMS

Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)

Time frame: 10 weeks

Brain Perfusion measured by fMRI

Brain Perfusion at 10 week measured by MRI

Time frame: 10 weeks

Brain Morphology measured by MRI

Brain Morphology at 10 weeks measured by MRI

Time frame: 10 weeks

Secondary Outcomes

Body composition measured by DEXA

Body composition at 10 weeks measured by DEXA

Time frame: 10 weeks

Physical Function measured by 6 minute walking test

Physical Function at 10 weeks measured by 6 minute walking test

Time frame: 10 weeks

Data from ClinicalTrials.gov

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