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Trial record 20 of 21 for:    Tesamorelin OR Egrifta[TREATMENT] AND HIV [CONDITION]

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

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ClinicalTrials.gov Identifier: NCT02553603
Recruitment Status : Recruiting
First Posted : September 17, 2015
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Growth Hormone Releasing Hormone (GHRH) Drug: Placebo Growth Hormone Releasing Hormone Phase 1

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Cognitive Function measured by SLUMS [ Time Frame: 10 weeks ]
    Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)

  2. Brain Perfusion measured by fMRI [ Time Frame: 10 weeks ]
    Brain Perfusion at 10 week measured by MRI

  3. Brain Morphology measured by MRI [ Time Frame: 10 weeks ]
    Brain Morphology at 10 weeks measured by MRI


Secondary Outcome Measures :
  1. Body composition measured by DEXA [ Time Frame: 10 weeks ]
    Body composition at 10 weeks measured by DEXA

  2. Physical Function measured by 6 minute walking test [ Time Frame: 10 weeks ]
    Physical Function at 10 weeks measured by 6 minute walking test



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553603


Contacts
Contact: Christopher Danesi, MS 409-772-8126 cpdanesi@utmb.edu
Contact: William Durham, PhD 409-772-8702 wjdurham@utmb.edu

Locations
United States, Texas
The University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Christopher Danesi, MS    409-772-8126    cpdanesi@utmb.edu   
Contact: William Durham, PhD    409-772-8702    wjdurham@utmb.edu   
Principal Investigator: Randall J Urban, MD         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Randall J Urban, MD University of Texas

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02553603     History of Changes
Other Study ID Numbers: 15-0086
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: February 2018

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

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Hormones
Growth Hormone-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs