Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-01-02 @ 4:10 AM
Study NCT ID:
NCT05010603
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Late Onset Alzheimer's Disease
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and samples from autopsy/brain tissue.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of genes identified to be associated with the risk of AD', 'timeFrame': '5 years', 'description': "Genetic Linkage Analysis to Identify Genes Associated with the risk of Alzheimer's Disease: Identification of genes by performing genetic linkage analysis, in order to detect the chromosomal location of genes that may increase the risk of Alzheimer's disease."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genetic testing', 'Genetic influence'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The goal of this study is to is to focus on the genetic influences on Alzheimer's Disease (AD) risk. The investigators are looking for families and/or individuals (affected or unaffected) of any ethic background (African American, Caucasian, and Hispanics) with a family history of AD and willing to participate.", 'detailedDescription': "The purpose of this study is to focus on the genetic influences on Alzheimer's disease (AD) risk. Specifically, the investigators hypothesize that one or more genes, other than the previously identified susceptibility gene apolipoprotein-E (APOE), or the 3 genes associated with early-onset familial AD, presenilin-1 (PS-1), presenilin-2 (PS-2) or B-amyloid precursor protein (APP), increase the risk of AD in families with multiple individuals affected with AD. The investigators propose to test this hypothesis by performing genetic linkage analysis in order to detect the chromosomal location of genes that may increase the risk of Alzheimer's disease. In addition, the investigators will study genes known to increase the risk of Alzheimer's disease and other related disorders such as early onset AD, Pick disease, corticobasal degeneration, progressive supranuclear palsy, and familial frontotemporal dementia with parkinsonism and Lewy Body Dementia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The investigators intend to recruit individuals from: 1) community-based studies; 2) the Alzheimer's Disease Research Center Memory Disorders Center; 3) the private offices of the study neurologists; 4) public recruitment; 5) referrals from the Alzheimer's Association; 6) referrals from the NCRAD; 7)previously unidentified members of existing families not previously recruited. The investigators will also use advertisements such as radio, television and newspapers.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Established diagnosis of definite or probable AD or have a diagnosis of a related neurodegenerative disorder such as Frontotemporal Dementia (FTD) or Lewy Body Dementia (LBD) (will also recruit sporadic FTD and LBD) cases.\n* a living sibling with probable or possible AD;\n* a third living relative affected with AD (onset age 50 or older) or unaffected (60 or older);\n* participants in the proband's generation with an identified companion serving as an informant;\n* participants who have capacity to consent or participants lacking capacity to consent with a surrogate/proxy in place to provide consent.\n\nExclusion Criteria:\n\n* failure to identify an appropriate informant;\n* uncertainty of the clinical diagnosis of Alzheimer's disease or other related disorder;\n* discovery of additional diagnosis that could account for the clinical manifestations;\n* unwillingness to participate;\n* failure to identify a living sibling with AD or other related disorder (except in the cases of sporadic FTD and sporadic LBD);\n* participants lacking the capacity to consent who do not have a surrogate or proxy or next of kin to provide consent."}, 'identificationModule': {'nctId': 'NCT05010603', 'acronym': 'LOAD', 'briefTitle': "Late Onset Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': "Late Onset Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'AAAP0479'}, 'secondaryIdInfos': [{'id': '5U24AG056270', 'link': 'https://reporter.nih.gov/quickSearch/5U24AG056270', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Families with a history of Alzheimer's Disease", 'description': "Families with two or more family members affected with Alzheimer's Disease", 'interventionNames': ['Genetic: Blood Draw', "Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test"]}, {'label': 'Un-related, non-demented controls', 'description': 'Un-related, non-demented healthy controls over age 55', 'interventionNames': ['Genetic: Blood Draw', "Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test"]}, {'label': "Individuals with Dementia (Alzheimer's Disease)", 'description': 'Individuals with dementia over the age of 65', 'interventionNames': ['Genetic: Blood Draw', "Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test"]}], 'interventions': [{'name': 'Blood Draw', 'type': 'GENETIC', 'description': 'Collection of blood samples for genetic testing', 'armGroupLabels': ["Families with a history of Alzheimer's Disease", "Individuals with Dementia (Alzheimer's Disease)", 'Un-related, non-demented controls']}, {'name': "Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test", 'type': 'OTHER', 'description': 'Memory Test', 'armGroupLabels': ["Families with a history of Alzheimer's Disease", "Individuals with Dementia (Alzheimer's Disease)", 'Un-related, non-demented controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Payne', 'role': 'CONTACT'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33124', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Larry Deon', 'role': 'CONTACT'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Aurora', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Corey Woods', 'role': 'CONTACT'}], 'facility': 'Rush University', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Farber', 'role': 'CONTACT'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Farber', 'role': 'CONTACT'}], 'facility': 'NCRAD at Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55901', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Hanzel', 'role': 'CONTACT'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joanne Norton', 'role': 'CONTACT'}], 'facility': 'Joanne Norton', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dolly Reyes-Dumeyer', 'role': 'CONTACT', 'email': 'dr2290@cumc.columbia.edu', 'phone': '212-305-5953'}, {'name': 'Amanda Chan', 'role': 'CONTACT', 'email': 'akc2177@cumc.columbia.edu', 'phone': '917-696-3082'}, {'name': 'Richard P Mayeux, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christiane Reitz, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ruth Ottman, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27695', 'city': 'Raleigh', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Takiyah Starks', 'role': 'CONTACT'}], 'facility': 'North Carolina State University', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elise Weamer', 'role': 'CONTACT'}], 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Browning', 'role': 'CONTACT'}], 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Dolly Reyes-Dumeyer', 'role': 'CONTACT', 'email': 'dr2290@cumc.columbia.edu', 'phone': '212-305-5953'}, {'name': 'Amanda Chan', 'role': 'CONTACT', 'email': 'akc2177@cumc.columbia.edu', 'phone': '917-696-3082'}], 'overallOfficials': [{'name': 'Richard P. Mayeux, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'url': 'https://osp.od.nih.gov', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data is currently available', 'ipdSharing': 'YES', 'description': "Data is stored in a secured database at Columbia University and de-identified data will be sent to the National Cell Repository for Alzheimer's disease. DNA will be stored at the National Cell Repository for Alzheimer's disease (NCRAD) at Indiana University. In addition to the blood sample, year of birth, family history of dementia, and diagnosis will be sent to NCRAD. DNA and associated clinical and demographic data will be made available to qualified and approved researchers studying the genetics of AD, aging, and related disorders. If the participant agrees, his/her de-identified samples and data will be made available to investigators studying the genetics of any human disease. Identity of participants will not be shared with NCRAD or with any investigators.", 'accessCriteria': 'When requesting samples to NCRAD the "Master Agreement for Transfer of Materials to NCRAD" and related Appendix A must be completed prior to the transfer of any samples. The Master Material Transfer Agreement (MTA) agreement is between the Institutions and is not Investigator specific. Therefore, if you think your Institution may already have a Master MTA in place with NCRAD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}