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

Completed · Phase 1 · Has a placebo group

Conditions studied: Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT02553603

Run by

The University of Texas Medical Branch, Galveston

People needed

22

Starts

2017-07-18

Expected to finish

2019-01-17

Last updated by the study team

2019-11-04

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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