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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Drug: Placebo Growth Hormone Releasing Hormone; Drug: Growth Hormone Releasing Hormone (GHRH)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)	10 weeks
Brain Perfusion measured by fMRI	Brain Perfusion at 10 week measured by MRI	10 weeks
Brain Morphology measured by MRI	Brain Morphology at 10 weeks measured by MRI	10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston

Study record dates

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: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Growth Substances; Hormones; Growth Hormone-Releasing Hormone; Tesamorelin
• 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