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

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Mild Cognitive Impairment

Treatments: Drug: Placebo Growth Hormone Releasing Hormone; Drug: Growth Hormone Releasing Hormone (GHRH)

Study type: Interventional

Funder types: Other

Identifiers

NCT02553603

15-0086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 4 patient groups, including a placebo group

Mild Cognitive Impairment, Placebo

Placebo Comparator group

Description:

Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).

Treatment:

Drug: Placebo Growth Hormone Releasing Hormone

Non-cognitively impaired, Placebo

Placebo Comparator group

Description:

Subjects aged 55- 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).

Treatment:

Drug: Placebo Growth Hormone Releasing Hormone

Mild Cognitive Impairment, GHRH

Experimental group

Description:

Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).

Treatment:

Drug: Growth Hormone Releasing Hormone (GHRH)

Non-cognitively impaired, GHRH

Experimental group

Description:

Subjects aged 55 - 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).

Treatment:

Drug: Growth Hormone Releasing Hormone (GHRH)