Massive Alzheimer's study aims to unlock secrets of memory loss

NCT ID NCT05617014

Knowledge-focused Sponsor: University of Southern California Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study follows 1,500 volunteers with normal memory, mild cognitive impairment, or Alzheimer's over several years. Researchers use brain scans, memory tests, and blood samples to track how the disease progresses. The goal is to find better ways to diagnose and treat Alzheimer's, including in groups often left out of research.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

55 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Newly Enrolled Participants, CN Cohort: 1. Participant may or may not have a significant subjective memory concern as reported by participant, study partner, or clinician. 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. Inclusion Criteria for Newly Enrolled Participants, MCI Cohort 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 Inclusion Criteria for Newly Enrolled Participants, DEM Cohort 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 Inclusion Criteria for Newly Enrolled Participants, All Cohorts 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. Inclusion Criteria for Rollover Participants, All Cohorts The following additional inclusion criteria apply to all diagnostic categories for rollover participants only: 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 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: 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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognition Disorders Cognitive Dysfunction dementia Pick disease Plaque, Amyloid

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Dementia Mild cognitive impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

65 sites in 2 countries. The list below names each one and where it is.
The official record

The full official record for this study. This one lists no contact details, but it is the first place any would appear.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Albany Medical College

Albany, New York, 12208, United States
AllianceChicago

Chicago, Illinois, 60654, United States
Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States
Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States
Barrow Neurological Institute

Phoenix, Arizona, 85013, United States
Baylor College of Medicine

Houston, Texas, 77030, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States
Boston University

Boston, Massachusetts, 02118, United States
Brigham and Women's Hospital

Boston, Massachusetts, 21155, United States
Butler Hospital, Memory and Aging Program

Providence, Rhode Island, 02906, United States
Case Western Reserve University

Cleveland, Ohio, 44122, United States
Central States Research

Tulsa, Oklahoma, 74136, United States
Charter Research

Orlando, Florida, 32803, United States
Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas

Las Vegas, Nevada, 89101, United States
Clinical Directors Network, Inc

New York, New York, 10018, United States
Columbia University Irving Medical Center

New York, New York, 10032, United States
Dent Neurological Institute

Buffalo, New York, 142261727, United States
Duke University Medical Center

Durham, North Carolina, 27705, United States
Emory University

Atlanta, Georgia, 30322, United States
Georgetown University

Washington D.C., District of Columbia, 200072145, United States
Gonzalez MD & Aswad MD Health Services

Miami, Florida, 33135, United States
Howard University

Washington D.C., District of Columbia, 20060, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Johns Hopkins University

Baltimore, Maryland, 21224, United States
Mayo Clinic Alzheimer's Disease Research Center

Rochester, Minnesota, 55901, United States
Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States
Mount Sinai School of Medicine

New York, New York, 100296552, United States
Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, 109621159, United States
New York University Langone Medical Center

New York, New York, 10016, United States
Northwestern University

Chicago, Illinois, 60611, United States
Ohio State University

Columbus, Ohio, 43210, United States
Oregon Health & Science University

Portland, Oregon, 97239, United States
Parkwood Institute

London, Ontario, N6C 0A7, Canada
Ralph H. Johnson VA Health Care System

Charleston, South Carolina, 29401, United States
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
Rush University Memory Clinic

Chicago, Illinois, 60612, United States
Stanford University

Palo Alto, California, 94304, United States
Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada
The Fenway Institute - Fenway Health

Boston, Massachusetts, 02215, United States
UBC Hospital Clinic for Alzheimer Disease and Related Disorders (CARD)

Vancouver, British Columbia, V6T 2B5, Canada
University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States
University of California, Davis

Walnut Creek, California, 94598, United States
University of California, Irvine

Irvine, California, 92697, United States
University of California, Los Angeles

Los Angeles, California, 90024, United States
University of California, San Diego

La Jolla, California, 92037, United States
University of California, San Francisco

San Francisco, California, 94158, United States
University of Chicago

Chicago, Illinois, 60637, United States
University of Florida

Gainesville, Florida, 32610, United States
University of Iowa

Iowa City, Iowa, 52242, United States
University of Kansas

Fairway, Kansas, 66205, United States
University of Kentucky

Lexington, Kentucky, 40536, United States
University of Michigan, Ann Arbor

Ann Arbor, Michigan, 48109, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States
University of Rochester

Rochester, New York, 14620, United States
University of South Florida Health Byrd Alzheimer's Institute

Tampa, Florida, 336134808, United States
University of Southern California

Los Angeles, California, 90033, United States
University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
University of Wisconsin

Madison, Wisconsin, 53792, United States
Vanderbilt University Medical Center Center for Cognitive Medicine

Nashville, Tennessee, 37212, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Washington University, St Louis

St Louis, Missouri, 63108, United States
Wien Center

Miami Beach, Florida, 33140, United States
Yale University

New Haven, Connecticut, 06520, United States

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