Alzheimer's Plasma Extension

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Southern California
Study ID
NCT06416072
Status
Enrolling By Invitation

Conditions

  • Alzheimer's Disease (AD)
  • Preclinical Alzheimer's Disease

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • NAV4694 — RADIATION
    Amyloid PET imaging with NAV4694 injection

Study Details

The goal of this observational study is to learn how Alzheimer's disease-related blood biomarkers, brain amyloid, and memory and thinking abilities change over time. The study will include up to 3,000 people who previously did not qualify for an anti-amyloid Alzheimer's disease prevention trial based on their amyloid eligibility. Participants may have previously screened for the AHEAD 3-45 Study, A4 Study, or another anti-amyloid Alzheimer's disease prevention trial. The main questions this study aims to answer are: * Can Alzheimer's disease-related blood tests help predict future buildup of amyloid in the brain? * How are changes in Alzheimer's disease-related blood biomarkers related to changes in brain amyloid, memory, thinking, and self-reported cognitive function? * Do these changes differ based on factors such as sex, APOE genetic status, race, ethnicity, socioeconomic status, or social factors? Participants will be followed for about 6 years. They will complete memory and thinking assessments and questionnaires and provide blood samples. Some participants may also be asked to take part in optional activities, including brain imaging with positron emission tomography (PET) or magnetic resonance imaging (MRI), digital cognitive assessments, and questionnaires about habits and social factors.

Key Dates

First listed
May 16, 2024
Start date
Sep 21, 2023
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Cohort 1: AHEAD 3-45 Participants
    Approximately 1,500 participants who consented to participate in the AHEAD 3-45 Study and screen failed due to a negative amyloid PET scan or screen failed prior to PET imaging
  • Arm: Cohort 2: Other Anti-Amyloid Prevention Trial Participants
    Approximately 1,500 participants who previously screen failed from the A4 Study or another anti-amyloid prevention trial on the basis of amyloid eligibility.

Primary Outcome Measure

Rate of change from Baseline through Month 72 in plasma beta-amyloid (Aβ) 40 or 42 ratio [ Time Frame: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72 ]

Locations (56)

FacilityCityStateZIPSite coordinators
University of Alabama, BirminghamBirminghamAlabama35233-
Banner Alzheimer's InstitutePhoenixArizona85006-
Banner Sun Health Research InstituteSun CityArizona85351-
University of California, IrvineIrvineCalifornia92697-
University of Southern CaliforniaLos AngelesCalifornia90033-
Stanford UniversityPalo AltoCalifornia94304-
Sharp Neurocognitive Research CenterSan DiegoCalifornia92123-
University of California, San FranciscoSan FranciscoCalifornia94158-
University of California, DavisWalnut CreekCalifornia94598-
Yale University School of MedicineNew HavenConnecticut06510-
Georgetown UniversityWashington D.C.District of Columbia20007-
Howard UniversityWashington D.C.District of Columbia20060-
Brain Matters ResearchDelray BeachFlorida33445-
Mayo Clinic, JacksonvilleJacksonvilleFlorida32224-
K2 Medical Research - The VillagesLady LakeFlorida32159-
K2 Medical Research, LLCMaitlandFlorida32751-
Gonzalez MD & Aswad MD Health ServicesMiamiFlorida33135-
Wien Center for Clinical ResearchMiami BeachFlorida33140-
Charter ResearchOrlandoFlorida32803-
University of South Florida - Health Byrd Alzheimer InstituteTampaFlorida33613-
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
Indiana UniversityIndianapolisIndiana46202-
University of KansasFairwayKansas66205-
University of KentuckyLexingtonKentucky40504-
Johns Hopkins UniversityBaltimoreMaryland21224-
Boston UniversityBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts21155-
Headlands Eastern MA LLCPlymouthMassachusetts02360-
University of Michigan, Ann ArborAnn ArborMichigan48105-
Mayo Clinic, RochesterRochesterMinnesota55905-
Washington University, St. LouisSt LouisMissouri63108-
Cleveland Clinic Lou Ruvo Center for Brain Health, Las VegasLas VegasNevada89101-
Columbia UniversityNew YorkNew York10032-
Mount Sinai School of MedicineNew YorkNew York10029-
University of Rochester Medical CenterRochesterNew York14620-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Case Western Reserve UniversityBeachwoodOhio44122-
Cleveland Clinic Lou Ruvo Center for Brain Health, OhioClevelandOhio44195-
Ohio State UniversityColumbusOhio43210-
Central States Research, LLCTulsaOklahoma74136-
Oregon Health & Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of PittsburghPittsburghPennsylvania15213-
Butler Hospital Memory and Aging ProgramProvidenceRhode Island02906-
Ralph H. Johnson VA Health Care SystemCharlestonSouth Carolina29401-
Vanderbilt University Medical Center Center for Cognitive MedicineNashvilleTennessee37212-
University of Texas, Southwestern MC at DallasDallasTexas75390-
Baylor College of MedicineHoustonTexas77030-
Houston Methodist Neurological InstituteHoustonTexas77030-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
Eastern Virginia Medical School at Old Dominion UniversityNorfolkVirginia23510-
National Clinical Research Inc.RichmondVirginia23294-
University of Washington, Memory and Brain Wellness CenterSeattleWashington98195-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By research site
University of Alabama, Birmingham· Birmingham, ALBanner Alzheimer's Institute· Phoenix, AZBanner Sun Health Research Institute· Sun City, AZUniversity of California, Irvine· Irvine, CAUniversity of Southern California· Los Angeles, CAStanford University· Palo Alto, CA

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