Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02564692
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-09
First Post:
2015-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GeneMatch: A Program of the Alzheimer's Prevention Registry to Match Individuals to Studies Based on Apolipoprotein E (APOE) Genotype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500000}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of individuals who enroll in GeneMatch', 'timeFrame': '15 years'}], 'secondaryOutcomes': [{'measure': 'Number of individuals referred to research studies', 'timeFrame': '15 years'}, {'measure': 'Number of individuals who enroll in research studies', 'timeFrame': '15 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '30772251', 'type': 'RESULT', 'citation': "Langbaum JB, Karlawish J, Roberts JS, Wood EM, Bradbury A, High N, Walsh TL, Gordon D, Aggarwal R, Davis P, Stowell C, Trisko L, Langlois CM, Reiman EM, Tariot PN. GeneMatch: A novel recruitment registry using at-home APOE genotyping to enhance referrals to Alzheimer's prevention studies. Alzheimers Dement. 2019 Apr;15(4):515-524. doi: 10.1016/j.jalz.2018.12.007. Epub 2019 Feb 13."}]}, 'descriptionModule': {'briefSummary': "The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify a large group of people interested in participating in research studies or clinical trials based in part on their genetic background. This genetic information will be used to match interested individuals to studies, providing a recruitment resource to the Alzheimer's scientific community. Interested individuals should visit www.endALZnow.org/GeneMatch to join the GeneMatch program.", 'detailedDescription': "The primary objectives of the Alzheimer's Prevention Registry GeneMatch program are to (1) identify and characterize a large cohort of people who are interested in, and may be eligible to participate in, current and future preclinical Alzheimer's disease research studies and clinical trials based on their genetic background, and (2) provide information to these individuals about research studies for which they may be eligible, based in part on their genetic background. Cognitively unimpaired individuals age 50 to 90, inclusive, are eligible to enroll in GeneMatch. GeneMatch will provide participants with a genetic sample kit (a cheek swab) to test for a specific gene called apolipoproteins E (APOE). GeneMatch does not disclose the results of the APOE test to participants. GeneMatch may use the APOE test results to match participants to research studies. Participants are under no obligation to pursue these study opportunities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This large research study will ultimately enroll 500,000 adults. We will recruit subjects from all over the United States, as everything is done via email, mail, or/and phone.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 50-90, inclusive\n* Provide basic demographic, medical history, and contact information\n* Consent to APOE genotyping without receiving results\n* Live in the United States\n\nExclusion Criteria:\n\n* Unable to comply with this project's protocol requirements\n* Self-reported diagnosis of dementia or any other objective cognitive impairment syndrome"}, 'identificationModule': {'nctId': 'NCT02564692', 'briefTitle': "GeneMatch: A Program of the Alzheimer's Prevention Registry to Match Individuals to Studies Based on Apolipoprotein E (APOE) Genotype", 'organization': {'class': 'OTHER', 'fullName': 'Banner Health'}, 'officialTitle': "Alzheimer's Prevention Registry GeneMatch Program", 'orgStudyIdInfo': {'id': 'APR-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Banner Alzheimer's Institute", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Jessica B Langbaum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Banner Alzheimer's Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Banner Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Director, Research Strategy', 'investigatorFullName': 'Jessica Langbaum, PhD', 'investigatorAffiliation': 'Banner Health'}}}}