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Iniziativa di neuroimaging per la malattia di Alzheimer 4 (ADNI4)

23 settembre 2026 aggiornato da: Paul S. Aisen, University of Southern California

Iniziativa di neuroimaging per la malattia di Alzheimer 4 (ADNI4)

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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Since its launch in 2004, the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been a landmark public-private partnership focused on developing and validating biomarkers for Alzheimer's disease (AD) and improving clinical trial design. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies and integrates clinical, cognitive, imaging, genetic, and biochemical biomarker data to characterize the full spectrum of Alzheimer's disease, from normal cognition through dementia.

The ADNI4 study is a multi-center, non-randomized, longitudinal, natural history, non-treatment study. Approximately 1,500 participants will be enrolled across three cohorts: cognitively normal (CN), mild cognitive impairment (MCI), and dementia (DEM). Participants between the ages of 55 and 90 years will be enrolled at sites across the United States and Canada. Approximately 750 participants will be newly enrolled into ADNI4, and approximately 750 participants will be rollover participants continuing from prior ADNI studies. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed longitudinally across the three cohorts.

Participants enrolled in ADNI4 will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic testing, positron emission tomography (PET) imaging for amyloid and tau, magnetic resonance imaging (MRI), and collection of cerebrospinal fluid (CSF) for up to five years.

ADNI4 incorporates both in-clinic and remote approaches, including web-based cognitive assessments and blood-based biomarkers, to support scalable identification and longitudinal monitoring of individuals across the disease continuum and to inform future clinical trial design.

ADNI4 also includes the Together Exploring Aging Minds (TEAM-ADNI) cohort, a small complementary sub-cohort that evaluates community-based recruitment and flexible approaches to participant identification, enrollment, and longitudinal data collection.

Across cohorts, ADNI4 aims to validate imaging and fluid biomarkers, improve clinical trial design, characterize longitudinal cognitive and biomarker changes, and identify predictors of disease progression.

For more information, please visit the ADNI4 Study website: https://www.adni4.org/

Tipo di studio

Osservativo

Iscrizione (Stimato)

1500

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V6T 2B5
    - UBC Hospital Clinic for Alzheimer Disease and Related Disorders (CARD)
- Ontario
  - London, Ontario, Canada, N6C 0A7
    - Parkwood Institute
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Health Sciences Centre
Stati Uniti
- Alabama
  - Birmingham, Alabama, Stati Uniti, 35233
    - University of Alabama at Birmingham
- Arizona
  - Phoenix, Arizona, Stati Uniti, 85006
    - Banner Alzheimer's Institute
  - Phoenix, Arizona, Stati Uniti, 85013
    - Barrow Neurological Institute
  - Sun City, Arizona, Stati Uniti, 85351
    - Banner Sun Health Research Institute
- California
  - Irvine, California, Stati Uniti, 92697
    - University of California, Irvine
  - La Jolla, California, Stati Uniti, 92037
    - University of California, San Diego
  - Los Angeles, California, Stati Uniti, 90033
    - University of Southern California
  - Los Angeles, California, Stati Uniti, 90024
    - University of California, Los Angeles
  - Palo Alto, California, Stati Uniti, 94304
    - Stanford University
  - San Francisco, California, Stati Uniti, 94158
    - University of California, San Francisco
  - Walnut Creek, California, Stati Uniti, 94598
    - University of California, Davis
- Connecticut
  - New Haven, Connecticut, Stati Uniti, 06520
    - Yale University
- District of Columbia
  - Washington D.C., District of Columbia, Stati Uniti, 20060
    - Howard University
  - Washington D.C., District of Columbia, Stati Uniti, 200072145
    - Georgetown University
- Florida
  - Gainesville, Florida, Stati Uniti, 32610
    - University of Florida
  - Jacksonville, Florida, Stati Uniti, 32224
    - Mayo Clinic, Jacksonville
  - Miami, Florida, Stati Uniti, 33135
    - Gonzalez MD & Aswad MD Health Services
  - Miami Beach, Florida, Stati Uniti, 33140
    - Wien Center
  - Orlando, Florida, Stati Uniti, 32803
    - Charter Research
  - Tampa, Florida, Stati Uniti, 336134808
    - University of South Florida Health Byrd Alzheimer's Institute
- Georgia
  - Atlanta, Georgia, Stati Uniti, 30322
    - Emory University
- Illinois
  - Chicago, Illinois, Stati Uniti, 60611
    - Northwestern University
  - Chicago, Illinois, Stati Uniti, 60637
    - University of Chicago
  - Chicago, Illinois, Stati Uniti, 60654
    - AllianceChicago
  - Chicago, Illinois, Stati Uniti, 60612
    - Rush University Memory Clinic
- Indiana
  - Indianapolis, Indiana, Stati Uniti, 46202
    - Indiana University
- Iowa
  - Iowa City, Iowa, Stati Uniti, 52242
    - University of Iowa
- Kansas
  - Fairway, Kansas, Stati Uniti, 66205
    - University of Kansas
- Kentucky
  - Lexington, Kentucky, Stati Uniti, 40536
    - University of Kentucky
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21224
    - Johns Hopkins University
- Massachusetts
  - Boston, Massachusetts, Stati Uniti, 02118
    - Boston University
  - Boston, Massachusetts, Stati Uniti, 02115
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, Stati Uniti, 21155
    - Brigham and Women's Hospital
  - Boston, Massachusetts, Stati Uniti, 02215
    - The Fenway Institute - Fenway Health
- Michigan
  - Ann Arbor, Michigan, Stati Uniti, 48109
    - University of Michigan, Ann Arbor
- Minnesota
  - Rochester, Minnesota, Stati Uniti, 55901
    - Mayo Clinic Alzheimer's Disease Research Center
- Missouri
  - St Louis, Missouri, Stati Uniti, 63108
    - Washington University, St Louis
- Nevada
  - Las Vegas, Nevada, Stati Uniti, 89101
    - Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas
- New York
  - Albany, New York, Stati Uniti, 12208
    - Albany Medical College
  - Buffalo, New York, Stati Uniti, 142261727
    - Dent Neurological Institute
  - New York, New York, Stati Uniti, 10032
    - Columbia University Irving Medical Center
  - New York, New York, Stati Uniti, 10016
    - New York University Langone Medical Center
  - New York, New York, Stati Uniti, 100296552
    - Mount Sinai School of Medicine
  - New York, New York, Stati Uniti, 10018
    - Clinical Directors Network, Inc
  - Orangeburg, New York, Stati Uniti, 109621159
    - Nathan Kline Institute for Psychiatric Research
  - Rochester, New York, Stati Uniti, 14620
    - University of Rochester
- North Carolina
  - Durham, North Carolina, Stati Uniti, 27705
    - Duke University Medical Center
  - Winston-Salem, North Carolina, Stati Uniti, 27157
    - Wake Forest University Health Sciences
- Ohio
  - Cleveland, Ohio, Stati Uniti, 44122
    - Case Western Reserve University
  - Columbus, Ohio, Stati Uniti, 43210
    - Ohio State University
- Oklahoma
  - Tulsa, Oklahoma, Stati Uniti, 74136
    - Central States Research
- Oregon
  - Portland, Oregon, Stati Uniti, 97239
    - Oregon Health & Science University
- Pennsylvania
  - Philadelphia, Pennsylvania, Stati Uniti, 19104
    - University of Pennsylvania
  - Pittsburgh, Pennsylvania, Stati Uniti, 15213
    - University of Pittsburgh
- Rhode Island
  - Providence, Rhode Island, Stati Uniti, 02903
    - Rhode Island Hospital
  - Providence, Rhode Island, Stati Uniti, 02906
    - Butler Hospital, Memory and Aging Program
- South Carolina
  - Charleston, South Carolina, Stati Uniti, 29401
    - Ralph H. Johnson VA Health Care System
- Tennessee
  - Nashville, Tennessee, Stati Uniti, 37212
    - Vanderbilt University Medical Center Center for Cognitive Medicine
- Texas
  - Dallas, Texas, Stati Uniti, 75390
    - University of Texas Southwestern Medical Center
  - Houston, Texas, Stati Uniti, 77030
    - Baylor College of Medicine
  - San Antonio, Texas, Stati Uniti, 78229
    - University of Texas Health Science Center at San Antonio
- Wisconsin
  - Madison, Wisconsin, Stati Uniti, 53792
    - University of Wisconsin

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 55 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Cognitively normal (CN), mild cognitive impairment (MCI), and dementia (DEM) participants.

Descrizione

Inclusion Criteria for Newly Enrolled Participants, CN Cohort:

Participant may or may not have a significant subjective memory concern as reported by participant, study partner, or clinician.
Normal memory function documented by scoring above demographically-adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
1. ≥9 for 16 or more years of education
2. ≥ 5 for 8-15 years of education
3. ≥ 3 for 0-7 years of education
4. Note: cut-offs may be modified over time as the field evolves in this area
Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
Clinical Dementia Rating = 0. Memory Box score must be 0.
Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living.
Stability of Permitted Medications for 4 weeks. In particular, participants may:
1. Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 years)
2. Estrogen replacement therapy is permissible
3. Gingko biloba is permissible, but discouraged
4. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening.

Inclusion Criteria for Newly Enrolled Participants, MCI Cohort

Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
Abnormal memory function documented by scoring within the demographically- adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
1. ≤11 for 16 or more years of education
2. ≤9 for 8-15 years of education
3. ≤6 for 0-7 years of education.
4. Note: cut-offs may be modified over time as the field evolves in this area.
Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5
General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made by the site physician at the time of the screening visit.
Stability of Permitted Medications for 4 weeks. In particular, participants may:
1. Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)
2. Estrogen replacement therapy is permissible
3. Gingko biloba is permissible, but discouraged
4. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
5. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen
6. Aducanumab and any other approved treatments for the neurobiology of AD if stable for 24 weeks prior to screen

Inclusion Criteria for Newly Enrolled Participants, DEM Cohort

Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
Abnormal memory function documented by scoring within the demographically- adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
1. ≤11 for 16 or more years of education
2. ≤9 for 8-15 years of education
3. ≤6 for 0-7 years of education.
4. Note: cut-offs may be modified over time as the field evolves in this area.
Mini-Mental State Exam score between 20 and 28 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
Clinical Dementia Rating = 0.5 or 1.0.
Meets the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines for Dementia (2011)
Stability of Permitted Medications for 4 weeks. In particular, participants may:
1. Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)
2. Estrogen replacement therapy is permissible
3. Gingko biloba is permissible, but discouraged
4. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
5. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen
6. Aducanumab and any other approved treatments for the neurobiology of AD if stable for 24 weeks prior to screen

Inclusion Criteria for Newly Enrolled Participants, All Cohorts

Geriatric Depression Scale score less than 10.
Age between 55-90 years (inclusive).
Study partner who has frequent contact with the participant (i.e., minimum average of 2 hours per week) and may be able to accompany the participant to clinic visits or provide information remotely (e.g. over the phone).
Visual and auditory acuity adequate for neuropsychological testing.
Good general health with no diseases expected to interfere with the study.
Participant is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile).
Willing and able to participate in a longitudinal imaging study.
Must be literate and speak English or Spanish fluently.
Agrees to collection of blood for GWAS, APOE testing, DNA and RNA testing
Agrees to collection of blood for biomarker testing.
The Administrative Core, described in section 9.1.1, will collaborate with leadership from all Cores to review the blood biomarker data from the remote blood cohort and select participants to join the in-clinic cohort. See ADNI4: Remote protocol.
Agrees to participate in the ADNI study which includes cognitive evaluation, MRI and PET scans.
Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood.

Inclusion Criteria for Rollover Participants, All Cohorts

The following additional inclusion criteria apply to all diagnostic categories for rollover participants only:

Must have been enrolled and followed in one of the following previous ADNI studies: ADNIGO, ADNI2, ADNI3 for at least one year.
Willing and able to continue to participant in an ongoing longitudinal study. A reduced battery of tests is allowable.
Study partner may be available who has frequent contact with the participant (i.e., minimum average of 2 hours per week), and may be able to accompany the participant to clinic visits or provide information remotely (e.g. over the phone).

Exclusion Criteria for Newly Enrolled Participants, CN Cohort:

1.Any significant neurologic disease, such as Parkinson's disease, vascular cognitive impairment/dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities

Exclusion Criteria for Newly Enrolled Participants, MCI and DEM Cohorts:

1.Any significant neurologic disease other than suspected Alzheimer's disease, such as Parkinson's disease (Parkinsonian symptoms complicating MCI/AD are acceptable), vascular cognitive impairment dementia (multiple lacunes less than or equal to 1.5 cm and/or extensive white matter changes are acceptable), Huntington's disease, normal pressure hydrocephalus, brain tumor (clinically insignificant meningioma acceptable), progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.

Exclusion Criteria for Newly Enrolled Participants, All Cohorts:

Additional exclusion criteria apply to all diagnostic categories for newly enrolled participants:

Screening/Baseline MRI brain scan with evidence of infection, or other clinically significant focal lesions. Participants with cortical strokes, not large enough to distort anatomy, multiple lacunar infarctions or extensive white matter disease are allowed.
Screening/Baseline MRI brain scan with evidence of large structural abnormalities that would corrupt image analytical pipelines - e.g. large hemispheric infarcts, large areas of encephalomalacia, large arachnoid cysts
Unable to complete MRIs for any reason (e.g. pacemaker or other implanted metal devices, severe claustrophobia, anxiety which prevents MRI scans, too large to fit, etc.).
Current major depression, bipolar disorder as described in DMS-IV within the past 1 year. Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder.
History of schizophrenia (DSM-5 criteria).
History of alcohol or substance disorder within the past 2 years (DSM-5 criteria).
Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
Clinically significant abnormalities in B12, or thyroid function tests that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
Residence in skilled nursing facility
Current use of specific psychoactive medications (e.g. certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.), at the discretion of the clinician.
Current use of any other exclusionary medications.
Investigational agents are prohibited for five half-lives or one month, whichever time period is longer, prior to entry and for the duration of the trial.
Participation in clinical studies involving neuropsychological measures being collected more than once time per year.
Female that is pregnant, lactating, or of childbearing potential.
Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Modelli osservazionali: COHORT
Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte Gruppo / Coorte Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
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.	Radiazione: Neuraceq Amyloid PET imaging with Florbetaben (Neuraceq) injection Altri nomi: Florbetaben Radiazione: Amyvid Amyloid PET imaging with Amyvid (Florbetapir) injection Altri nomi: Florbetapir Radiazione: Tauvid Tau PET imaging with Tauvid (Flortaucipir) injection Altri nomi: 18F-AV-1451 AV-1451 Flortaucipir Radiazione: MK-6240 Tau PET imaging with MK-6240 injection Altri nomi: [18F] MK-6240 florquinitau F-18 Radiazione: NAV4694 Amyloid PET imaging with NAV4694 injection Altri nomi: [18F]NAV4694 [18F]AZD4694 Radiazione: PI-2620 Tau PET imaging with PI-2620 injection Altri nomi: [18F]PI-2620
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.	Radiazione: Neuraceq Amyloid PET imaging with Florbetaben (Neuraceq) injection Altri nomi: Florbetaben Radiazione: Amyvid Amyloid PET imaging with Amyvid (Florbetapir) injection Altri nomi: Florbetapir Radiazione: Tauvid Tau PET imaging with Tauvid (Flortaucipir) injection Altri nomi: 18F-AV-1451 AV-1451 Flortaucipir Radiazione: MK-6240 Tau PET imaging with MK-6240 injection Altri nomi: [18F] MK-6240 florquinitau F-18 Radiazione: NAV4694 Amyloid PET imaging with NAV4694 injection Altri nomi: [18F]NAV4694 [18F]AZD4694 Radiazione: PI-2620 Tau PET imaging with PI-2620 injection Altri nomi: [18F]PI-2620
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.	Radiazione: Neuraceq Amyloid PET imaging with Florbetaben (Neuraceq) injection Altri nomi: Florbetaben Radiazione: Amyvid Amyloid PET imaging with Amyvid (Florbetapir) injection Altri nomi: Florbetapir Radiazione: Tauvid Tau PET imaging with Tauvid (Flortaucipir) injection Altri nomi: 18F-AV-1451 AV-1451 Flortaucipir Radiazione: MK-6240 Tau PET imaging with MK-6240 injection Altri nomi: [18F] MK-6240 florquinitau F-18 Radiazione: NAV4694 Amyloid PET imaging with NAV4694 injection Altri nomi: [18F]NAV4694 [18F]AZD4694 Radiazione: PI-2620 Tau PET imaging with PI-2620 injection Altri nomi: [18F]PI-2620

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Rate of enrollment of Underrepresented Populations (URPs) Lasso di tempo: 5 years	The ADNI4 study aims to increased inclusion of underrepresented populations (URPs) to improve generalizability of results and advance our understanding of health disparities across URPs	5 years

Misure di risultato secondarie

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Southern California

Collaboratori

National Institute on Aging (NIA)

Northern California Institute of Research and Education

Alzheimer's Therapeutic Research Institute

Investigatori

Investigatore principale: Ronald Petersen, MD, PHD, Mayo Clinic
Investigatore principale: Paul Aisen, MD, USC Alzheimer's Therapeutic Research Institute (ATRI)
Direttore dello studio: Michael Weiner, MD, University of California, San Francisco

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 giugno 2023

Completamento primario (Stimato)

31 luglio 2027

Completamento dello studio (Stimato)

31 luglio 2027

Date di iscrizione allo studio

Primo inviato

2 novembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

8 novembre 2022

Primo Inserito (Effettivo)

15 novembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

ATRI-011
U19AG024904 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Tipo di informazioni di supporto alla condivisione IPD

STUDIO_PROTOCOLLO
LINFA
ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Misura del risultato	Misura Descrizione	Lasso di tempo
Variazione della deposizione di amiloide misurata con florbetaben Lasso di tempo: Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.		Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.
Variazione della deposizione di amiloide misurata da NAV4694 Lasso di tempo: Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.		Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.
Variazione della deposizione di amiloide misurata con florbetapir Lasso di tempo: Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.		Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.
Variazione della deposizione di tau misurata da flortaucipir Lasso di tempo: Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.		Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.
Variazione della deposizione di tau misurata da MK-6240 Lasso di tempo: Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.		Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.
Variazione della deposizione di tau misurata da PI-2620 Lasso di tempo: Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.		Coorti CN e MCI: basale/iniziale, mesi 24 e 48. Coorti DEM: basale/iniziale e mese 24 e 36.
Cambiamento nella struttura del cervello mediante risonanza magnetica (MRI) Lasso di tempo: Coorti CN e MCI: Screening/Iniziale, Mesi 24 e 48. Coorti DEM: Screening/Iniziale e Mesi 24 e 36.		Coorti CN e MCI: Screening/Iniziale, Mesi 24 e 48. Coorti DEM: Screening/Iniziale e Mesi 24 e 36.
Rate of change in cognition as measured by the Category Fluency (Animals) Tests Lasso di tempo: CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.	This is a measure of verbal fluency in which the participant is asked to generate examples from the semantic categories (animals) in successive one-minute trials	CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Measurement of Everyday Cognition 12-item (12-Item ECog) Lasso di tempo: CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.	Everyday Cognition (ECog) is a brief questionnaire assessing the participant's capability to perform normal everyday tasks, in comparison to activity levels at their own understanding of their prior baseline, using a 5-point scale. Previous research on this instrument indicates that ECog correlates well with established measures of functional status and global cognition but only weakly with age and education. ADNI4 will use the 12-item ECog with language updates from Farias et al. 2021 meant to improve generalizability across diverse groups.	CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Logical Memory Test I and II (immediate and delayed paragraph recall) Lasso di tempo: CN Cohorts: Screening/Initial, Months 24 and 48. MCI Cohorts: Screening/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Screening/Initial, Months 12 and 24.	We will use a modified episodic memory measure from the Wechsler Memory Scale- Revised (WMS-R) 24. In this modified version, free recall of one short story will be elicited immediately after it is read aloud to the participant and again after a thirty-minute delay	CN Cohorts: Screening/Initial, Months 24 and 48. MCI Cohorts: Screening/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Screening/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Montreal Cognitive Assessment (MoCA) Lasso di tempo: CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.	The Montreal Cognitive Assessment test (MoCA) is, similar to the MMSE, a brief, 30- point cognitive assessment designed to detect participants at the MCI stage of cognitive dysfunction. This instrument has been shown to have adequate sensitivity and specificity in clinical settings to detect suspected MCI. The performance of the MoCA will be followed to determine its ability to differentiate among the three diagnostic groups in ADNI4	CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Multilingual Naming Test (MINT) Lasso di tempo: CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.	The Multilingual Naming Test (MINT) is a test of object picture naming designed to include items that are comparable across English, Spanish, Mandarin and Hebrew. It replaces the Boston Naming Test (BNT) in the Uniform Data Set of the NIA- funded Alzheimer's Disease Centers because the BNT contains items that are not of the same level of difficulty for Spanish- and English-speakers	CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Perceived Stress (PSS) Lasso di tempo: CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.	An important consideration in measuring cognition is current stress. Research suggests that current perceived stress can affect neurocognitive functioning (Lupien et al., 2009). Thus, measuring current stress in the present study is an important element of study procedures. The PSS measures current stress levels and stressful experiences in the last month. It asks about experiences such as feeling in control of one's life, feeling the ability to be productive, feeling overwhelmed, and being upset by unexpected events (Cohen, Kamarck, & Mermelstein, 1983). These items are rated on a Likert scale of 1-5, with 1 representing "Almost Always" and 5 representing "Almost Never." In scoring, the scale is reverse coded where appropriate, such that a low score is indicative of a lower level of perceived stress.	CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Rey Auditory Verbal Learning Test (AVLT) Lasso di tempo: CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.	The AVLT is a list-learning task, which assesses multiple cognitive parameters associated with learning and memory.	CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Trail Making Test: A and B Lasso di tempo: CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.	These two tests progress from a numerical connect-the-dots puzzle to a more challenging alternation between alpha- and numerical order. Although both Parts A and B depend on visuomotor and perceptual-scanning skills, Part B also requires considerable cognitive flexibility in shifting from number to letter sets under time pressure.	CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Clinical Dementia Rating (CDR) Lasso di tempo: CN Cohorts: Screening/Initial, Months 24 and 48. MCI Cohorts: Screening/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Screening/Initial, Months 12 and 24.	The Clinical Dementia Rating (CDR) describes five degrees of impairment in performance on each of 6 categories of cognitive functioning including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. A higher score indicates more impairment.	CN Cohorts: Screening/Initial, Months 24 and 48. MCI Cohorts: Screening/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Screening/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Activities of Daily Living (ADL) Functional Assessment Questionnaire (FAQ) Lasso di tempo: CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.	Based on an interview with a caregiver or qualified partner, a participant is rated on his/her ability to carry out ten complex activities of daily living.	CN Cohorts: Baseline/Initial, Months 24 and 48. MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12 and 24.
Rate of change in cognition as measured by the Neuropsychiatric Inventory (NPI) Lasso di tempo: CN and MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12, 24 and 36.	The Neuropsychiatric Inventory (NPI) is a well-validated, reliable, multi-item instrument to assess psychopathology in AD based on an interview with a caregiver or qualified study partner. The NPI evaluates both the frequency and severity of 12 neuropsychiatric features, including: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating disorders. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequent, continuously present); severity from 1(mild), 2 (moderate) and 3 (severe) and distress from 0 (no distress) to 5 (very severe/extreme distress). For each behavioral domain, there are 4 scores: frequency, severity, domain score (frequency x severity) and caregiver distress. The total score is the sum of all domain scores. The distress score is not included in the total NPI score.	CN and MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12, 24 and 36.
Rate of change in cognition as measured by the Neuropsychiatric Inventory Q (NPI-Q) Lasso di tempo: CN and MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12, 24 and 36.	The Neuropsychiatric Inventory Q was designed as a version of the Neuropsychiatric Inventory (NPI) that could be administered more quickly and over the telephone. The NPI-Q measures the burden of 12 neuropsychiatric symptoms of dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequent, continuously present); severity from 1(mild), 2 (moderate) and 3 (severe) and distress from 0 (no distress) to 5 (very severe/extreme distress). For each behavioral domain, there are 4 scores: frequency, severity, domain score (frequency x severity) and caregiver distress. The total score is the sum of all domain scores. The distress score is not included in the total NPI score.	CN and MCI Cohorts: Baseline/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Baseline/Initial, Months 12, 24 and 36.
Rate of change in cognition as measured by the Geriatric Depression Scale (GDS) Short Form Lasso di tempo: CN Cohorts: Screening/Initial, Months 24 and 48. MCI Cohorts: Screening/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Screening/Initial, Months 12 and 24.	The GDS Short Form is a self-report scale designed to screen for symptoms of depression in the elderly. The assessment is administered by clinic personnel to the study participant and consists of 15 questions that the participant is asked to answer yes or no on the basis of how they felt over the past week. Answers to 5 of the items are negatively oriented for depression (e.g., Do you feel full of energy?) and 10 positively oriented (e.g., Do you often feel helpless?). One point is given for each appropriate positive or negative answer indicative of a symptom of depression, for a possible total of 15 points. Although differing sensitivities and specificities have been obtained across studies, for clinical purposes a total score of 0-5 are considered likely to be normal and scores of 6-15 are considered to be more likely to be depressed.	CN Cohorts: Screening/Initial, Months 24 and 48. MCI Cohorts: Screening/Initial, Months 12, 24, 36 and 48. DEM Cohorts: Screening/Initial, Months 12 and 24.
Change in amyloid β-peptide (Aβ) 40 (Aβ40) in Cerebrospinal Fluid (CSF) Lasso di tempo: CN and MCI Cohorts: Baseline/Initial, Months 24 and 48. DEM Cohorts: Baseline/Initial and Month 24 and 36.	Cerebrospinal fluid (CSF) samples will be used to measure the levels of amyloid β-peptide (Aβ) 40. CSF Aβ40 is a key Alzheimer's disease (AD) biomarker that reflects pathological aggregation of amyloid in the brain.	CN and MCI Cohorts: Baseline/Initial, Months 24 and 48. DEM Cohorts: Baseline/Initial and Month 24 and 36.
Change in amyloid β-peptide (Aβ) 42 (Aβ42) in Cerebrospinal Fluid (CSF) Lasso di tempo: CN and MCI Cohorts: Baseline/Initial, Months 24 and 48. DEM Cohorts: Baseline/Initial and Month 24 and 36.	Cerebrospinal fluid (CSF) samples will be used to measure the levels of amyloid β-peptide (Aβ) 42. CSF Aβ42 is a key Alzheimer's disease (AD) biomarker that reflects pathological aggregation of amyloid in the brain.	CN and MCI Cohorts: Baseline/Initial, Months 24 and 48. DEM Cohorts: Baseline/Initial and Month 24 and 36.
Change in Cerebrospinal Fluid (CSF) Levels of Total Tau Lasso di tempo: CN and MCI Cohorts: Baseline/Initial, Months 24 and 48. DEM Cohorts: Baseline/Initial and Month 24 and 36.	Cerebrospinal fluid (CSF) samples will be used to measure the levels of total tau protein in the brain to assess impact on brain tau as a relevant Alzheimer's Disease (AD) biomarker.	CN and MCI Cohorts: Baseline/Initial, Months 24 and 48. DEM Cohorts: Baseline/Initial and Month 24 and 36.
Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 181 Lasso di tempo: CN and MCI Cohorts: Baseline/Initial, Months 24 and 48. DEM Cohorts: Baseline/Initial and Month 24 and 36.	Cerebrospinal fluid (CSF) samples will be used to measure the levels of phospho-tau 181 protein in the brain to assess impact on brain tau as a relevant Alzheimer's Disease (AD) biomarker.	CN and MCI Cohorts: Baseline/Initial, Months 24 and 48. DEM Cohorts: Baseline/Initial and Month 24 and 36.

Iniziativa di neuroimaging per la malattia di Alzheimer 4 (ADNI4)