Clinical trial NCT02553603: The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Official title: The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild Cognitive Impairment
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 22
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Cognitive Function measured by SLUMS
timeFrame: 10 weeks
measure: Brain Perfusion measured by fMRI
timeFrame: 10 weeks
measure: Brain Morphology measured by MRI
timeFrame: 10 weeks
Secondary outcomes:
measure: Body composition measured by DEXA
timeFrame: 10 weeks
measure: Physical Function measured by 6 minute walking test
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Randall J Urban, MD
role: PRINCIPAL_INVESTIGATOR
References: