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

November 1, 2019 updated by: The University of Texas Medical Branch, Galveston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Drug: Placebo Growth Hormone Releasing Hormone
Placebo GHRH to be given once daily for 10 weeks
Other Names:
  • Placebo
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).
Drug: Placebo Growth Hormone Releasing Hormone
Placebo GHRH to be given once daily for 10 weeks
Other Names:
  • Placebo
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).
Drug: Growth Hormone Releasing Hormone (GHRH)
Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
Other Names:
  • Egrifta
  • tesamorelin
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).
Drug: Growth Hormone Releasing Hormone (GHRH)
Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
Other Names:
  • Egrifta
  • tesamorelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Function measured by SLUMS
Time Frame: 10 weeks
Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)
10 weeks
Brain Perfusion measured by fMRI
Time Frame: 10 weeks
Brain Perfusion at 10 week measured by MRI
10 weeks
Brain Morphology measured by MRI
Time Frame: 10 weeks
Brain Morphology at 10 weeks measured by MRI
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition measured by DEXA
Time Frame: 10 weeks
Body composition at 10 weeks measured by DEXA
10 weeks
Physical Function measured by 6 minute walking test
Time Frame: 10 weeks
Physical Function at 10 weeks measured by 6 minute walking test
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2017

Primary Completion (Actual)

January 17, 2019

Study Completion (Actual)

January 17, 2019

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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