Alzheimer's Disease Neuroimaging Initiative 4

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Southern California
Study ID
NCT05617014
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Neuraceq — RADIATION
    Amyloid PET imaging with Florbetaben (Neuraceq) injection
  • Amyvid — RADIATION
    Amyloid PET imaging with Amyvid (Florbetapir) injection
  • Tauvid — RADIATION
    Tau PET imaging with Tauvid (Flortaucipir) injection
  • MK-6240 — RADIATION
    Tau PET imaging with MK-6240 injection
  • NAV4694 — RADIATION
    Amyloid PET imaging with NAV4694 injection
  • PI-2620 — RADIATION
    Tau PET imaging with PI-2620 injection

Study Details

The Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4) is a non-randomized, longitudinal, natural history study designed to validate biomarkers, improve clinical trial design, and advance understanding of Alzheimer's disease across the full disease spectrum. Building on the success of ADNI1, ADNI-GO, ADNI2, and ADNI3, ADNI4 integrates clinical, cognitive, imaging, genetic, and fluid biomarker data to characterize disease progression and predict cognitive decline. ADNI4 includes both in-clinic and remote cohorts and a small complementary sub-cohort, Together Exploring Aging Minds (TEAM-ADNI), which evaluates community-based recruitment and longitudinal data collection approaches.

Key Dates

Start date
Jun 9, 2023
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: Cognitively Normal (CN)
    700 participants with no apparent memory problems, which is anticipated to include 250 newly enrolled participants and 450 rollover participants from the prior ADNI3 study without apparent memory problems.
  • Arm: Mild Cognitive Impairment (MCI)
    450 participants with mild cognitive impairment (MCI), which is anticipated to include 250 newly enrolled participants and 200 rollover participants from the prior ADNI3 study with MCI.
  • Arm: Dementia (DEM)
    350 participants with mild dementia (DEM), which is anticipated to include 250 newly enrolled participants and 100 participants followed from the prior ADNI3 study with dementia.

Primary Outcome Measure

Rate of enrollment of Underrepresented Populations (URPs) [ Time Frame: 5 years ]

Locations (59)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Banner Alzheimer's InstitutePhoenixArizona85006-
Barrow Neurological InstitutePhoenixArizona85013-
Banner Sun Health Research InstituteSun CityArizona85351-
University of California, IrvineIrvineCalifornia92697-
University of California, San DiegoLa JollaCalifornia92037-
University of California, Los AngelesLos AngelesCalifornia90024-
University of Southern CaliforniaLos AngelesCalifornia90033-
Stanford UniversityPalo AltoCalifornia94304-
University of California, San FranciscoSan FranciscoCalifornia94158-
University of California, DavisWalnut CreekCalifornia94598-
Yale UniversityNew HavenConnecticut06520-
Georgetown UniversityWashington D.C.District of Columbia200072145-
Howard UniversityWashington D.C.District of Columbia20060-
Mayo Clinic, JacksonvilleJacksonvilleFlorida32224-
Gonzalez MD & Aswad MD Health ServicesMiamiFlorida33135-
Wien CenterMiami BeachFlorida33140-
Charter ResearchOrlandoFlorida32803-
University of South Florida Health Byrd Alzheimer's InstituteTampaFlorida336134808-
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Rush University Memory ClinicChicagoIllinois60612-
University of ChicagoChicagoIllinois60637-
Indiana UniversityIndianapolisIndiana46202-
University of IowaIowa CityIowa52242-
University of KansasFairwayKansas66205-
University of KentuckyLexingtonKentucky40536-
Johns Hopkins UniversityBaltimoreMaryland21224-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Boston UniversityBostonMassachusetts02118-
Brigham and Women's HospitalBostonMassachusetts21155-
University of Michigan, Ann ArborAnn ArborMichigan48109-
Mayo Clinic Alzheimer's Disease Research CenterRochesterMinnesota55901-
Washington University, St LouisSt LouisMissouri63108-
Cleveland Clinic Lou Ruvo Center for Brain Health, Las VegasLas VegasNevada89101-
Albany Medical CollegeAlbanyNew York12208-
Dent Neurological InstituteBuffaloNew York142261727-
Clinical Directors Network, IncNew YorkNew York10018-
Columbia University Irving Medical CenterNew YorkNew York10032-
Mount Sinai School of MedicineNew YorkNew York100296552-
New York University Langone Medical CenterNew YorkNew York10016-
Nathan Kline Institute for Psychiatric ResearchOrangeburgNew York109621159-
University of RochesterRochesterNew York14620-
Duke University Medical CenterDurhamNorth Carolina27705-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Case Western Reserve UniversityClevelandOhio44122-
Ohio State UniversityColumbusOhio43210-
Central States ResearchTulsaOklahoma74136-
Oregon Health & Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of PittsburghPittsburghPennsylvania15213-
Butler Hospital, Memory and Aging ProgramProvidenceRhode Island02906-
Rhode Island HospitalProvidenceRhode Island02903-
Ralph H. Johnson VA Health Care SystemCharlestonSouth Carolina29401-
Vanderbilt University Medical Center Center for Cognitive MedicineNashvilleTennessee37212-
University of Texas Southwestern Medical CenterDallasTexas75390-
Baylor College of MedicineHoustonTexas77030-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Alabama at Birmingham· Birmingham, ALBanner Alzheimer's Institute· Phoenix, AZBarrow Neurological Institute· Phoenix, AZBanner Sun Health Research Institute· Sun City, AZUniversity of California, Irvine· Irvine, CAUniversity of California, San Diego· La Jolla, CA

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