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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Drug: Growth Hormone Releasing Hormone (GHRH)
* Drug: Placebo Growth Hormone Releasing Hormone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Mild Cognitive Impairment, Placebo<br>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<br>* Placebo GHRH to be given once daily for 10 weeks<br>* Other names: Placebo;|
| Placebo Comparator: Non-cognitively impaired, Placebo<br>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<br>* Placebo GHRH to be given once daily for 10 weeks<br>* Other names: Placebo;|
| Experimental: Mild Cognitive Impairment, GHRH<br>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)<br>* Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks<br>* Other names: tesamorelin;|
| Experimental: Non-cognitively impaired, GHRH<br>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)<br>* Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks<br>* Other names: tesamorelin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function measured by SLUMS | Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS) | 10 weeks | 
| Brain Perfusion measured by fMRI | Brain Perfusion at 10 week measured by MRI | 10 weeks | 
| Brain Morphology measured by MRI | Brain Morphology at 10 weeks measured by MRI | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition measured by DEXA | Body composition at 10 weeks measured by DEXA | 10 weeks | 
| Physical Function measured by 6 minute walking test | Physical Function at 10 weeks measured by 6 minute walking test | 10 weeks |