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

• Status: Completed
• Trial end date: 2019-01-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Growth Hormone-Releasing Hormone; Hormones; Tesamorelin

Criteria

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