Can a new drug stop Alzheimer's before it starts? major trial underway

NCT ID NCT04468659

Disease control Sponsor: Eisai Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an investigational drug called lecanemab in people aged 55-80 who have early signs of Alzheimer's-related brain changes but no memory problems yet. The goal is to see if the drug can slow cognitive decline and reduce amyloid buildup over about 4 years. Around 1400 participants will receive either lecanemab or a placebo, with an extension phase to check long-term safety.

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Study facts

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

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,400 people

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

Started

Jul 2020

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

55 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Participants must meet all of the following criteria to be included in this study: 1. Male or female, age 55 to 80 years inclusive at the time of informed consent, with a plasma biomarker result that is predictive of intermediate or elevated brain amyloid at Screening or known before Screening to have elevated or intermediate amyloid according to previous PET, cerebrospinal fluid (CSF), or plasma testing • Those 55 to 64 must have 1 of the following additional risk factors, given the relatively low rates of amyloid positivity less than (\<) 65 years, before screening: * First degree relative diagnosed with dementia onset before age 75, or * Known to possess at least 1 apolipoprotein E4 variant (APOE4) allele, or * Known before screening to have elevated brain amyloid according to previous plasma biomarker results, PET imaging, or CSF testing 2. Global Clinical Dementia Rating (CDR) score of 0 at screening 3. Mini Mental State Examination score greater than or equal to (\>=) 27 (with educational adjustments) at screening. 4. Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at screening of \>=6 5. A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately greater than (\>) 40 Centiloids on screening scan A3 Trial: Intermediate levels of brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 Centiloids on screening scan 6. Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the participant (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the participant's daily function 7. Provide written (or electronic, if allowed per country-specific regulations) informed consent 8. Willing and able to comply with all aspects of the protocol For extension phase : 1. Completed the Core Study, or meet the following progression criteria during the Core Study: * Two consecutive CDR visits with Global Scores \> zero when measured at least 6 months apart within the Core Study * The principal investigator's confirmation that the participant has clinically declined consistent progression to EAD 2. Must continue to have a study partner who is willing and able to provide follow-up information on the participant throughout the course of the Extension Phase. The study partner must provide separate written informed consent for the Extension Phase. Study partners must continue to have sufficient contact such that the investigator feels the study partner can provide meaningful information about the participant's daily functions 3. Provide written informed consent for the Extension Phase. If a participant lacks capacity to consent in the investigator's opinion, the participant's assent should be obtained, if required and in accordance with local laws, regulations, and customs, plus the written informed consent of a legal representative (capacity to consent and the definition of a legal representative should be determined in accordance with applicable local laws and regulations). In countries where local laws, regulations, and customs do not permit participants who lack capacity to consent to participate in this study (example, Spain), they will not be enrolled 4. Willing and able to comply with all aspects of the protocol Exclusion criteria: Participants who meet any of the following criteria will be excluded from this study: 1. Females who are breastfeeding or pregnant at screening or baseline 2. Females of childbearing potential who: • Within 28 days before study entry, did not use a highly effective method of contraception For sites outside of Europe, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception 3. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of screening 4. Current or history within the past 2 years of psychiatric diagnosis or symptoms that, in the opinion of the investigator, could interfere with study procedures 5. Contraindications to 3 Tesla magnetic resonance imaging (MRI) scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in-skull and cardiac devices other than those approved as safe for use in MRI scanners), or exhibit other significant pathological findings on brain MRI at Screening 6. Hypersensitivity to any monoclonal antibody treatment 7. Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study 8. Bleeding disorder that is not under adequate control (including a platelet count \<50,000 or international normalized ratio \[INR\] \>1.5) at screening 9. Results of laboratory tests conducted during screening that are outside the following limits: * Thyroid stimulating hormone (TSH) above normal range * Abnormally low (below lower limit of normal \[LLN\]) serum vitamin B12 levels for the testing laboratory (if participant is taking vitamin B12 injections, level should be at or above the LLN for the testing laboratory). A low vitamin B12 is exclusionary, unless the required follow-up labs (homocysteine and methylmalonic acid \[MMA\]) indicate that it is not physiologically significant 10. Known to be human immunodeficiency virus (HIV) positive 11. Any other clinically significant abnormalities that in the opinion of the investigator require further investigation or treatment or may interfere with study procedures or safety 12. Malignant neoplasms within 3 years of screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male participants with treatment cycles completed at least 6 months before screening). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before screening need not be excluded 13. Answer "yes" to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before screening, at screening, or at baseline, or has been hospitalized or treated for suicidal behavior in the past 5 years before screening 14. Known or suspected history of drug or alcohol abuse or dependence within 2 years before screening or a positive urine drug test at screening. Participants who test positive for benzodiazepines, opioids, or tetrahydrocannabinol (THC) in urine drug testing need not be excluded unless in the clinical opinion of the investigator this is due to potential drug abuse 15. Taking prohibited medications 16. Participation in a clinical study involving: * Any anti-amyloid plaque lowering immunotherapy (example, therapeutic monoclonal antibody or active anti-amyloid vaccine) at any time, unless it can be documented that the participant was randomized to placebo or never received study drug * Any immunoglobulin therapy, or vaccine within 6 months before Screening, unless it can be documented that the participant was randomized to placebo or never received study drug * Lecanemab * Any new chemical entities or investigational drug for AD within 6 months before randomization unless it can be documented that the participant received only placebo * Any other investigational medication or device study in the 8 weeks or 5 half-lives (whichever is longer) of the medication before randomization unless it can be documented that the participant was in a placebo treatment arm 17. Planned surgery during the pre-randomization phase or within 3 months of randomization, which requires general anesthesia For extension phase: 1. Discontinued from the Core Study or from study treatment 2. Under study drug interruption due to ARIA or other AE at the time of transition to the extension phase

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

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

Early preclinical Alzheimer's disease Preclinical Alzheimer's disease

Contacts and locations

Locations

AMC Research

Matthews, North Carolina, 28105, United States
Abington Neurological Associates

Abington, Pennsylvania, 19001, United States
Advanced Clinical Research Network, Corp

Coral Gables, Florida, 33134-1613, United States
Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, 08755, United States
Alzheimer's Research Australia

Nedlands, Western Australia, 06009, Australia
Alzheimer's Research and Treatment Center

Wellington, Florida, 33414, United States
Austin Hospital - Medical and Cognitive Research Unit

Ivanhoe, Victoria, Australia
Banner Alzheimer's Institute

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

Sun City, Arizona, 85351, United States
Barcelona Beta Brain Research Center (BBRC)

Barcelona, 08005, Spain
Baylor College of Medicine

Houston, Texas, 77030, United States
Boston University

Boston, Massachusetts, 02118, United States
Brain Matters Research

Delray Beach, Florida, 33445, United States
Brigham and Woman's Hospital Center for Alzheimer Research and Treatment

Boston, Massachusetts, 21155, United States
Bristol Brain Centre

Bristol, BS10 5NB, United Kingdom
Butler Hospital Memory and Aging Program

Providence, Rhode Island, 02906, United States
CALHN Cognitive Neurology Clinical Trials

Adelaide, South Australia, Australia
Calvary Mater Newcastle

Waratah, New South Wales, Australia
Case Western Reserve University/University Hospitals

Beachwood, Ohio, 44122, United States
Central States Research, LLC

Tulsa, Oklahoma, 74136, United States
Centricity Research

Hailfax, Nova Scotia, B3S 1L8, Canada
Charter Research

Winter Park, Florida, 31792, United States
Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States
Cleveland Clinic Lou Ruvo Center for Brain Health

Cleveland, Ohio, 44195, United States
Columbia University

New York, New York, 10032, United States
Columbus Memory Center

Columbus, Georgia, 31909, United States
Donald S.Marks, M.D.,P.C.

Plymouth, Massachusetts, 02360, United States
Duke Health Center

Durham, North Carolina, 27705, United States
Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States
Emory University

Atlanta, Georgia, 30329, United States
Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan
Fundacion CITA ALZHEIMER

Donostia / San Sebastian, 20009, Spain
Fundació ACE

Barcelona, 08028, Spain
Georgetown University

Washington D.C., District of Columbia, 20057, United States
Glasgow Memory Clinic

Glasgow, ML1 4UF, United Kingdom
Gonzalez MD & Aswad MD Health Sciences

Miami, Florida, 33125, United States
Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States
Hospital Universitario Marqués de Valdeciila

Santander, 39008, Spain
Hospital Universitario Quirón Salud Madrid

Madrid, 28223, Spain
Houston Methodist Neurological Institute

Houston, Texas, 77030, United States
Howard University

Washington D.C., District of Columbia, 20060, United States
ICR Clinical Research Hospital Tokyo

Shinjuku-Ku, Tokyo, 160-0004, Japan
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Imperial Memory Unit

London, W6 8RF, United Kingdom
Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States
Johns Hopkins University

Baltimore, Maryland, 21224, United States
K2 Medical Research - The Villages

Lady Lake, Florida, 32159, United States
K2 Medical Research, Llc

Maitland, Florida, 32751, United States
Keystone Clinical Studies, LLC

Norristown, Pennsylvania, 19403, United States
Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan
Koseikai Takeda Hospital

Kyoto, Kyoto, 600-8558, Japan
Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States
Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States
Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan
National Center for Geriatrics and Gerontology

Obu-shi, Aichi-ken, 474-8511, Japan
National Center of Neurology and Psychiatry

Kodaira-shi, Tokyo, 187-8551, Japan
National Clinical Research, Inc

Richmond, Virginia, 23294, United States
National University Hospital

Singapore, Singapore
Northwestern University

Chicago, Illinois, 60611, United States
Ohio State University

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

Portland, Oregon, 97239, United States
P-One Clinic, Keikokai Medical Corporation

Hachioji -shi, Tokyo, 192-0071, Japan
Parkwood Institute Main Building

London, Ontario, N6C0A7, Canada
Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 20403, United States
Renstar Medical Research

Ocala, Florida, 34470, United States
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
Rush University Medical Center

Chicago, Illinois, 60612, United States
SIBCR

Seattle, Washington, 98108, United States
Sharp Mesa Vista Hospital

San Diego, California, 92123, United States
Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, 247-8533, Japan
St Pancras Clinical Research

London, EC2Y 8EA, United Kingdom
St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia
Stanford University

Palo Alto, California, 94304, United States
Summit Research Network, Oregon

Portland, Oregon, 97210, United States
Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada
Synexus Clinical Research - Orlando

Orlando, Florida, 32806, United States
Synexus Clinical Research - The Villages

The Villages, Florida, 32162, United States
The University of Osaka Hospital

Suita-shi, Osaka, 565-0871, Japan
The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States
The University of Tokyo Hospital

Bunkyo-ku, Tokyo, 113-8655, Japan
Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology

Itabashi-ku, Tokyo, 173-0015, Japan
Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada
True North Clinical Research

New Minas, Nova Scotia, B4N 3R7, Canada
True North Clinical Research Inc.

New Minas, Nova Scotia, B4N 3R7, Canada
UCI MIND

Irvine, California, 92697-4285, United States
University of Alabama, Birmingham

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

Walnut Creek, California, 94598, United States
University of California, San Francisco

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

Fairway, Kansas, 66205, United States
University of Kentucky

Lexington, Kentucky, 40504, United States
University of Michigan

Ann Arbor, Michigan, 48105, United States
University of North Texas Health Sciences Center

Fort Worth, Texas, 76107, 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 Institute

Tampa, Florida, 33613, United States
University of Southern California

Los Angeles, California, 90033, United States
University of Texas, Southwestern MC at Dallas

Dallas, Texas, 75390, United States
University of Washington Memory and Brain Wellness Center

Seattle, Washington, 98104, United States
University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States
Vanderbilt University Medical Center

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
Westmead Hospital

Westmead, New South Wales, Australia
Wien Center for Clinical Research

Miami Beach, Florida, 33140, United States
Yale University School of Medicine

New Haven, Connecticut, 06510, United States

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