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

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Growth Hormone Releasing Hormone (GHRH)

Placebo Growth Hormone Releasing Hormone

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Mild Cognitive Impairment, Placebo

Non-cognitively impaired, Placebo

Mild Cognitive Impairment, GHRH

Non-cognitively impaired, GHRH

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Cognitive Function measured by SLUMS

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

Brain Perfusion measured by fMRI

Brain Perfusion at 10 week measured by MRI

Brain Morphology measured by MRI

Brain Morphology at 10 weeks measured by MRI

Secondary Outcome Measures

Body composition measured by DEXA

Body composition at 10 weeks measured by DEXA

Physical Function measured by 6 minute walking test

Physical Function at 10 weeks measured by 6 minute walking test

Full Information

NCT ID

NCT02553603

First Posted

September 3, 2015

Last Updated

November 1, 2019

Sponsor

The University of Texas Medical Branch, Galveston

1. Study Identification

Unique Protocol Identification Number

NCT02553603

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

July 18, 2017 (Actual)

Primary Completion Date

January 17, 2019 (Actual)

Study Completion Date

January 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild Cognitive Impairment, Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Non-cognitively impaired, Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Mild Cognitive Impairment, GHRH

Arm Type

Experimental

Arm Description

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

Arm Title

Non-cognitively impaired, GHRH

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Growth Hormone Releasing Hormone (GHRH)

Other Intervention Name(s)

Egrifta, tesamorelin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo Growth Hormone Releasing Hormone

Other Intervention Name(s)

Placebo

Intervention Description

Placebo GHRH to be given once daily for 10 weeks

Primary Outcome Measure Information:

Title

Cognitive Function measured by SLUMS

Description

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

Time Frame

10 weeks

Title

Brain Perfusion measured by fMRI

Description

Brain Perfusion at 10 week measured by MRI

Time Frame

10 weeks

Title

Brain Morphology measured by MRI

Description

Brain Morphology at 10 weeks measured by MRI

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Body composition measured by DEXA

Description

Body composition at 10 weeks measured by DEXA

Time Frame

10 weeks

Title

Physical Function measured by 6 minute walking test

Description

Physical Function at 10 weeks measured by 6 minute walking test

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Randall J Urban, MD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Medical Branch

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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