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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02553603 (opens ClinicalTrials.gov in a new tab)Other id15-0086
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
22 participants (actual)
Sponsor
The University of Texas Medical Branch, Galveston · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
18 Jul 2017
Primary completion
17 Jan 2019
Completion
17 Jan 2019
First posted
17 Sept 2015 (estimated)
Last update posted
4 Nov 2019
Conditions
Mild Cognitive Impairment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 1

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

    NCT02553603

    18 Jul 2017 to 17 Jan 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Growth Hormone Releasing Hormone (GHRH)Drug
  • Placebo Growth Hormone Releasing HormoneDrug

Arms4

  • Placebo comparator

    Mild Cognitive Impairment, Placebo

    Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).

  • Placebo comparator

    Non-cognitively impaired, Placebo

    Subjects aged 55- 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).

  • Experimental

    Mild Cognitive Impairment, GHRH

    Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).

  • Experimental

    Non-cognitively impaired, GHRH

    Subjects aged 55 - 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Cognitive Function measured by SLUMS

    Time frame · 10 weeks

    Registry description

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

  2. Brain Perfusion measured by fMRI

    Time frame · 10 weeks

    Registry description

    Brain Perfusion at 10 week measured by MRI

  3. Brain Morphology measured by MRI

    Time frame · 10 weeks

    Registry description

    Brain Morphology at 10 weeks measured by MRI

Secondary outcomes(2)

  1. Body composition measured by DEXA

    Time frame · 10 weeks

    Registry description

    Body composition at 10 weeks measured by DEXA

  2. Physical Function measured by 6 minute walking test

    Time frame · 10 weeks

    Registry description

    Physical Function at 10 weeks measured by 6 minute walking test

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2026

8 results

The effect of growth hormone-releasing hormone on cognition and brain connectivity in adults with cognition ranging from normal to mild cognitive impairment.

Stewart et al. 2026eNeurologicalSci

PMID 42382101PMC13316082DOI 10.1016/j.ensci.2026.100616PUB-42382101

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 55 Years up to 85 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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