Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-28 @ 1:48 AM
Study NCT ID:
NCT03727360
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2018-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise for Brain Health in the Fight Against Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and outcomes assessors are masked to APOE genotype. We do not share any data with care providers.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2018-10-30', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to 6 months in Rey Auditory Verbal Learning Test Sum of Trials 1-5', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Change from Baseline to 6 months in Resting Cerebral Blood Flow', 'timeFrame': 'Baseline and 6 months'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline to 6 months in VO2peak', 'timeFrame': 'Baseline and 6 months', 'description': 'Estimated peak rate of oxygen consumption, a measure of cardiorespiratory fitness'}, {'measure': 'Change from Baseline to 6 months in 6 Minute Walk Test', 'timeFrame': 'Baseline and 6 months', 'description': 'Distance walked in 6 minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Walking Exercise', 'Flexibility Exercise', 'Cognition', 'Memory', 'Magnetic Resonance Imaging'], 'conditions': ['Healthy Cognition']}, 'descriptionModule': {'briefSummary': "The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 60 to 80 years old\n* Fluent in English\n* Willingness to make the time commitment to participate in the project, including randomization to treatments\n* Physically inactive (physical activity not more than 2 days per week for the past 6 months)\n* Physician consent to undergo an exercise stress test and engage in moderate intensity exercise\n* Determined to be safe for MRI\n\nExclusion Criteria:\n\n* Neurological illnesses/conditions such as cerebral palsy, epi¬lepsy, brain tumor, chronic meningitis, multiple scle¬rosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease\n* Untreated hypertension, glaucoma, and chronic obstructive pul¬monary disease\n* Untreated severe major depression\n* Substance abuse or dependence\n* Current use of psychoactive medications, except selective serotonin/norepinephrine reuptake inhibitor antidepressants\n* Use of acetylcholinesterase inhibitors (e.g., Aricept)\n* Unstable or severe cardiovascular disease or asthmatic condition\n* History of transient ischemic attack, cerebral ischemia, or clinically diagnosed stroke\n* Diagnosis of mild cognitive impairment or dementia, or objective evidence of cognitive impairment"}, 'identificationModule': {'nctId': 'NCT03727360', 'briefTitle': "Exercise for Brain Health in the Fight Against Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, College Park'}, 'officialTitle': "Exercise for Brain Health in the Fight Against Alzheimer's Disease", 'orgStudyIdInfo': {'id': '1115946'}, 'secondaryIdInfos': [{'id': '1R01AG057552', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG057552', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Training', 'description': 'Group exercise and treadmill walking', 'interventionNames': ['Other: Exercise Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flexibility Control', 'description': 'Group exercise and flexibility exercise', 'interventionNames': ['Other: Flexibility Control']}], 'interventions': [{'name': 'Exercise Training', 'type': 'OTHER', 'description': 'Supervised exercise conducted four days per week for six months.', 'armGroupLabels': ['Exercise Training']}, {'name': 'Flexibility Control', 'type': 'OTHER', 'description': 'Supervised exercise conducted four days per week for six months.', 'armGroupLabels': ['Flexibility Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20742', 'city': 'College Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Department of Kinesiology', 'geoPoint': {'lat': 38.98067, 'lon': -76.93692}}], 'overallOfficials': [{'name': 'J. Carson Smith, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, College Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Marquette University', 'class': 'OTHER'}, {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}