Purpose

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

Eligibility

Eligible Ages
Between 55 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

The University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Christopher Danesi, MS
409-772-8126
cpdanesi@utmb.edu

More Details

NCT ID
NCT02553603
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Christopher Danesi, MS
409-772-8126
cpdanesi@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.