protocolSection identificationModule nctId: NCT06384573, orgStudyIdInfo id: DIAN-TU-003, secondaryIdInfos id: The Alzheimer's Association, type: OTHER_GRANT, domain: DIAN-TU-OLE-21-725093, briefTitle: DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease, acronym: DIAN-TU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-11, completionDateStruct date: 2029-11, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: Alzheimer's Association, collaborators name: Eisai Inc., descriptionModule briefSummary: This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression., conditionsModule conditions: Alzheimer's Disease, conditions: Dementia, conditions: Alzheimer's Disease, Familial, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: lecanemab, outcomesModule primaryOutcomes measure: The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama in Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Erik Roberson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: University of California San Diego Medical Center, city: La Jolla, state: California, zip: 92037, country: United States, contacts name: Doug Galasko, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: Indiana University School of Medicine, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Jared Brosch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Washington University in St. Louis, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Barbara Snider, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Sarah Berman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: University of Washington, city: Seattle, state: Washington, zip: 98195, country: United States, contacts name: Suman Jayadev, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, locations facility: Neuroscience Research Australia, city: Randwick, state: New South Wales, zip: 2031, country: Australia, contacts name: William Brooks, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.91439, lon: 151.24895, locations facility: The National Hospital for Neurology and Neurosurgery, city: London, state: Greater London, zip: WC1B 3BG, country: United Kingdom, contacts name: Catherine Mummery, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False