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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553603
• Other study ID #: 15-0086
• Status: Completed
• Phase: Phase 1
• Start date: July 18, 2017
• Est. completion date: January 17, 2019

Study information

• Verified date: October 2019
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• Growth Hormone Releasing Hormone (GHRH)
Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
• Placebo Growth Hormone Releasing Hormone
Placebo GHRH to be given once daily for 10 weeks

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Function measured by SLUMS	Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)	10 weeks
Primary	Brain Perfusion measured by fMRI	Brain Perfusion at 10 week measured by MRI	10 weeks
Primary	Brain Morphology measured by MRI	Brain Morphology at 10 weeks measured by MRI	10 weeks
Secondary	Body composition measured by DEXA	Body composition at 10 weeks measured by DEXA	10 weeks
Secondary	Physical Function measured by 6 minute walking test	Physical Function at 10 weeks measured by 6 minute walking test	10 weeks