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



Status:Recruiting
Conditions:Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:55 - 85
Updated:7/13/2018
Start Date:July 18, 2017
End Date:September 2019
Contact:Christopher Danesi, MS
Email:cpdanesi@utmb.edu
Phone:409-772-8126

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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.

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.

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
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Randall J Urban, MD
Phone: 409-772-8126
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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mi
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Galveston, TX
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