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Completed

NCT Number: NCT02553603

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

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Growth Hormone Releasing Hormone (GHRH)

Drug

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

Other names: Egrifta, tesamorelin

Placebo Growth Hormone Releasing Hormone

Drug

Placebo GHRH to be given once daily for 10 weeks

Other names: Placebo

Primary outcomes

  1. Cognitive Function measured by SLUMS

    Time frame: 10 weeks

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

  2. Brain Perfusion measured by fMRI

    Time frame: 10 weeks

    Brain Perfusion at 10 week measured by MRI

  3. Brain Morphology measured by MRI

    Time frame: 10 weeks

    Brain Morphology at 10 weeks measured by MRI

Secondary outcomes

  1. Body composition measured by DEXA

    Time frame: 10 weeks

    Body composition at 10 weeks measured by DEXA

  2. Physical Function measured by 6 minute walking test

    Time frame: 10 weeks

    Physical Function at 10 weeks measured by 6 minute walking test

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2015
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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