Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT02553603
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2015-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013007', 'term': 'Growth Hormone-Releasing Hormone'}, {'id': 'C479538', 'term': 'tesamorelin'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-01', 'studyFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Function measured by SLUMS', 'timeFrame': '10 weeks', 'description': 'Cognitive function at 10 weeks measured by the St Louis University Mental Status (SLUMS)'}, {'measure': 'Brain Perfusion measured by fMRI', 'timeFrame': '10 weeks', 'description': 'Brain Perfusion at 10 week measured by MRI'}, {'measure': 'Brain Morphology measured by MRI', 'timeFrame': '10 weeks', 'description': 'Brain Morphology at 10 weeks measured by MRI'}], 'secondaryOutcomes': [{'measure': 'Body composition measured by DEXA', 'timeFrame': '10 weeks', 'description': 'Body composition at 10 weeks measured by DEXA'}, {'measure': 'Physical Function measured by 6 minute walking test', 'timeFrame': '10 weeks', 'description': 'Physical Function at 10 weeks measured by 6 minute walking test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Subjects with MCI as well as healthy controls will be given GHRH at a dose of 1mg/day for 10 weeks.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 55 to ≤ 85 years\n* Ability to sign consent form (score ≥ on the Mini Mental State Examination, MMSE)\n* MCI group: MMSE scores of 23 - 26\n* Normal Control Group: MMSE scores of 27 - 30\n\nExclusion Criteria:\n\n* Diabetes\n* A neurologic condition other than MCI which might cause cognitive impairment\n* Baseline serum IGF-1 concentration greater than the midrange for healthy young adults (300ng/ml)\n* Presence of a pacemaker or metal implant\n* Heart Failure\n* Edema\n* Active malignancy\n* Carpal tunnel syndrome\n* Disruption of the hypothalamic pituitary axis such that the pituitary is expected to be insensitive to growth hormone secretagogues such as GHRH\n* Known allergy to tesamorelin or mannitol\n* Pregnancy\n* Significant heart, liver, kidney, blood or respiratory disease\n* Active cancer\n* Recent (within 6 months) treatment with anabolic steroids, GHRH or corticosteroids\n* Alcohol or drug abuse\n* MMSE \\< 23\n* Less than 12 years of education\n* Significant findings on screening tests, including but not limited to, blood counts, blood biochemistries, urinalysis, drug screening, HIV test, hepatitis panel, electrocardiogram\n* Other medical conditions deemed exclusionary by the study investigators'}, 'identificationModule': {'nctId': 'NCT02553603', 'briefTitle': 'The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': '15-0086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Mild Cognitive Impairment, Placebo', 'description': 'Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).', 'interventionNames': ['Drug: Placebo Growth Hormone Releasing Hormone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-cognitively impaired, Placebo', 'description': 'Subjects aged 55- 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving placebo Growth Hormone Releasing Hormone (GHRH).', 'interventionNames': ['Drug: Placebo Growth Hormone Releasing Hormone']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Cognitive Impairment, GHRH', 'description': 'Subjects aged 55 - 85 years, scored between 23- 26 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).', 'interventionNames': ['Drug: Growth Hormone Releasing Hormone (GHRH)']}, {'type': 'EXPERIMENTAL', 'label': 'Non-cognitively impaired, GHRH', 'description': 'Subjects aged 55 - 85 years, scored between 27-30 on screening Mini Mental Status Exam, receiving active Growth Hormone Releasing Hormone (GHRH).', 'interventionNames': ['Drug: Growth Hormone Releasing Hormone (GHRH)']}], 'interventions': [{'name': 'Growth Hormone Releasing Hormone (GHRH)', 'type': 'DRUG', 'otherNames': ['Egrifta', 'tesamorelin'], 'description': 'Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks', 'armGroupLabels': ['Mild Cognitive Impairment, GHRH', 'Non-cognitively impaired, GHRH']}, {'name': 'Placebo Growth Hormone Releasing Hormone', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo GHRH to be given once daily for 10 weeks', 'armGroupLabels': ['Mild Cognitive Impairment, Placebo', 'Non-cognitively impaired, Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Randall J Urban, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}