Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
1500 participants
OBSERVATIONAL
2023-06-09
2027-07-31
Brief Summary
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Detailed Description
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Participants between the ages of 55-90 (inclusive) will be enrolled at 59 sites in the United States and Canada. Approximately, 750 participants will be newly enrolled into the ADNI4 Study, while 750 participants will be rollover participants, continuing their participation from previous ADNI studies. Clinical/cognitive, imaging, biomarker, and genetic characteristics will be assessed across the three cohorts.
Participants enrolled in the ADNI4 Study will undergo longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET (amyloid and tau) and MRI scans and cerebral spinal fluid (CSF) collection for up to 5 years.
For more information, please visit the ADNI4 Study website: https://www.adni4.org/
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Neuraceq
Amyloid PET imaging with Florbetaben (Neuraceq) injection
Amyvid
Amyloid PET imaging with Amyvid (Florbetapir) injection
Tauvid
Tau PET imaging with Tauvid (Flortaucipir) injection
MK-6240
Tau PET imaging with MK-6240 injection
NAV4694
Amyloid PET imaging with NAV4694 injection
PI-2620
Tau PET imaging with PI-2620 injection
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.
Neuraceq
Amyloid PET imaging with Florbetaben (Neuraceq) injection
Amyvid
Amyloid PET imaging with Amyvid (Florbetapir) injection
Tauvid
Tau PET imaging with Tauvid (Flortaucipir) injection
MK-6240
Tau PET imaging with MK-6240 injection
NAV4694
Amyloid PET imaging with NAV4694 injection
PI-2620
Tau PET imaging with PI-2620 injection
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.
Neuraceq
Amyloid PET imaging with Florbetaben (Neuraceq) injection
Amyvid
Amyloid PET imaging with Amyvid (Florbetapir) injection
Tauvid
Tau PET imaging with Tauvid (Flortaucipir) injection
MK-6240
Tau PET imaging with MK-6240 injection
NAV4694
Amyloid PET imaging with NAV4694 injection
PI-2620
Tau PET imaging with PI-2620 injection
Interventions
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Neuraceq
Amyloid PET imaging with Florbetaben (Neuraceq) injection
Amyvid
Amyloid PET imaging with Amyvid (Florbetapir) injection
Tauvid
Tau PET imaging with Tauvid (Flortaucipir) injection
MK-6240
Tau PET imaging with MK-6240 injection
NAV4694
Amyloid PET imaging with NAV4694 injection
PI-2620
Tau PET imaging with PI-2620 injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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)
4. Clinical Dementia Rating = 0. Memory Box score must be 0.
5. Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living.
6. 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.
1. Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
2. 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.
3. 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)
4. Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5
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.
6. 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
1. Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
2. 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.
3. 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)
4. Clinical Dementia Rating = 0.5 or 1.0.
5. Meets the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines for Dementia (2011)
6. 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
1. Geriatric Depression Scale score less than 10.
2. Age between 55-90 years (inclusive).
3. 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).
4. Visual and auditory acuity adequate for neuropsychological testing.
5. Good general health with no diseases expected to interfere with the study.
6. Participant is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile).
7. Willing and able to participate in a longitudinal imaging study.
8. Must be literate and speak English or Spanish fluently.
9. Agrees to collection of blood for GWAS, APOE testing, DNA and RNA testing
10. Agrees to collection of blood for biomarker testing.
11. 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.
12. Agrees to participate in the ADNI study which includes cognitive evaluation, MRI and PET scans.
13. Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood.
1. Must have been enrolled and followed in one of the following previous ADNI studies: ADNIGO, ADNI2, ADNI3 for at least one year.
2. Willing and able to continue to participant in an ongoing longitudinal study. A reduced battery of tests is allowable.
3. 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
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.
1. 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.
2. 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
3. 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.).
4. 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.
5. Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder.
6. History of schizophrenia (DSM-5 criteria).
7. History of alcohol or substance disorder within the past 2 years (DSM-5 criteria).
8. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
9. 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.
10. Residence in skilled nursing facility
11. Current use of specific psychoactive medications (e.g. certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.), at the discretion of the clinician.
12. Current use of any other exclusionary medications.
13. 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.
14. Participation in clinical studies involving neuropsychological measures being collected more than once time per year.
15. Female that is pregnant, lactating, or of childbearing potential.
16. Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood.
55 Years
90 Years
ALL
Yes
Sponsors
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Northern California Institute of Research and Education
OTHER
National Institute on Aging (NIA)
NIH
Alzheimer's Therapeutic Research Institute
OTHER
University of Southern California
OTHER
Responsible Party
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Paul S. Aisen
Professor
Principal Investigators
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Michael Weiner, MD
Role: STUDY_DIRECTOR
University of California, San Francisco
Paul Aisen, MD
Role: PRINCIPAL_INVESTIGATOR
USC Alzheimer's Therapeutic Research Institute (ATRI)
Ronald Petersen, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of California, San Diego
La Jolla, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
University of California, Davis
Walnut Creek, California, United States
Yale University
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
Gonzalez MD & Aswad MD Health Services
Miami, Florida, United States
Wien Center
Miami Beach, Florida, United States
Charter Research
Orlando, Florida, United States
University of South Florida Health Byrd Alzheimer's Institute
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Memory Clinic
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas
Fairway, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States
Mayo Clinic Alzheimer's Disease Research Center
Rochester, Minnesota, United States
Washington University, St Louis
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas
Las Vegas, Nevada, United States
Albany Medical College
Albany, New York, United States
Dent Neurological Institute
Buffalo, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States
University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Central States Research
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Butler Hospital, Memory and Aging Program
Providence, Rhode Island, United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, United States
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Parkwood Institute
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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ATRI-011
Identifier Type: -
Identifier Source: org_study_id
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