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Preclinical Alzheimer's DiseasePhase 3NCT04468659

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

A Phase 3 study testing Lecanemab in people with Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease, run by Eisai Inc. at 107 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain… Read more about this study

Who is it for?
Ages 55 to 80 years
What is being tested?
Lecanemab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,400 participants
Where
107 sitesin 7 countries
Study dates
14 Jul 2020to 16 Jan 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria to be included in this study:
  • 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
Show all 20Show fewer
  • Global Clinical Dementia Rating (CDR) score of 0 at screening
  • Mini Mental State Examination score greater than or equal to (>=) 27 (with educational adjustments) at screening.
  • Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at screening of >=6
  • 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
  • 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
  • Provide written (or electronic, if allowed per country-specific regulations) informed consent
  • Willing and able to comply with all aspects of the protocol
  • For extension phase :
  • 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
  • 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
  • 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
  • Willing and able to comply with all aspects of the protocol

Who cannot join

  • Participants who meet any of the following criteria will be excluded from this study:
  • Females who are breastfeeding or pregnant at screening or baseline
  • 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
  • History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of screening
  • 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
Show all 29Show fewer
  • 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
  • Hypersensitivity to any monoclonal antibody treatment
  • 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
  • Bleeding disorder that is not under adequate control (including a platelet count <50,000 or international normalized ratio [INR] >1.5) at screening
  • 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
  • Known to be human immunodeficiency virus (HIV) positive
  • 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
  • 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
  • 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
  • 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
  • Taking prohibited medications
  • 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
  • Planned surgery during the pre-randomization phase or within 3 months of randomization, which requires general anesthesia
  • For extension phase:
  • Discontinued from the Core Study or from study treatment
  • Under study drug interruption due to ARIA or other AE at the time of transition to the extension phase

Trial locations and contacts

107 sites in 7 countries.

107 sites in 7 countries

United States72 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • University of Michigan

    Ann Arbor, Michigan, 48105

  • Emory University

    Atlanta, Georgia, 30329

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • Case Western Reserve University/University Hospitals

    Beachwood, Ohio, 44122

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35233

  • Boston University

    Boston, Massachusetts, 02118

  • Brigham and Woman's Hospital Center for Alzheimer Research and Treatment

    Boston, Massachusetts, 21155

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina, 20403

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Cleveland, Ohio, 44195

  • Columbus Memory Center

    Columbus, Georgia, 31909

  • Ohio State University

    Columbus, Ohio, 43210

  • Advanced Clinical Research Network, Corp

    Coral Gables, Florida, 33134-1613

  • University of Texas, Southwestern MC at Dallas

    Dallas, Texas, 75390

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Duke Health Center

    Durham, North Carolina, 27705

  • University of Kansas

    Fairway, Kansas, 66205

  • University of North Texas Health Sciences Center

    Fort Worth, Texas, 76107

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • UCI MIND

    Irvine, California, 92697-4285

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • K2 Medical Research - The Villages

    Lady Lake, Florida, 32159

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • University of Kentucky

    Lexington, Kentucky, 40504

  • University of Southern California

    Los Angeles, California, 90033

  • University of Wisconsin, Madison

    Madison, Wisconsin, 53792

  • K2 Medical Research, Llc

    Maitland, Florida, 32751

  • AMC Research

    Matthews, North Carolina, 28105

  • Gonzalez MD & Aswad MD Health Sciences

    Miami, Florida, 33125

  • Wien Center for Clinical Research

    Miami Beach, Florida, 33140

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Keystone Clinical Studies, LLC

    Norristown, Pennsylvania, 19403

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Synexus Clinical Research - Orlando

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Donald S.Marks, M.D.,P.C.

    Plymouth, Massachusetts, 02360

  • Summit Research Network, Oregon

    Portland, Oregon, 97210

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital Memory and Aging Program

    Providence, Rhode Island, 02906

  • National Clinical Research, Inc

    Richmond, Virginia, 23294

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14620

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • University of California, San Francisco

    San Francisco, California, 94158

  • University of Washington Memory and Brain Wellness Center

    Seattle, Washington, 98104

  • SIBCR

    Seattle, Washington, 98108

  • Washington University, St. Louis

    St Louis, Missouri, 63108

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • University of South Florida - Health Byrd Alzheimer Institute

    Tampa, Florida, 33613

  • Synexus Clinical Research - The Villages

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755

  • Central States Research, LLC

    Tulsa, Oklahoma, 74136

  • University of California, Davis

    Walnut Creek, California, 94598

  • Georgetown University

    Washington D.C., District of Columbia, 20057

  • Howard University

    Washington D.C., District of Columbia, 20060

  • Alzheimer's Research and Treatment Center

    Wellington, Florida, 33414

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Charter Research

    Winter Park, Florida, 31792

Other trials in United States

Japan13 sites

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • P-One Clinic, Keikokai Medical Corporation

    Hachioji -shi, Tokyo, 192-0071

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    Itabashi-ku, Tokyo, 173-0015

  • Shonan Kamakura General Hospital

    Kamakura-shi, Kanagawa, 247-8533

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • National Center of Neurology and Psychiatry

    Kodaira-shi, Tokyo, 187-8551

  • Koseikai Takeda Hospital

    Kyoto, Kyoto, 600-8558

  • National Center for Geriatrics and Gerontology

    Obu-shi, Aichi-ken, 474-8511

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka, Osaka, 532-0003

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • ICR Clinical Research Hospital Tokyo

    Shinjuku-Ku, Tokyo, 160-0004

  • The University of Osaka Hospital

    Suita-shi, Osaka, 565-0871

Other trials in Japan

Australia6 sites

  • CALHN Cognitive Neurology Clinical Trials

    Adelaide, South Australia

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales

  • Austin Hospital - Medical and Cognitive Research Unit

    Ivanhoe, Victoria

  • Alzheimer's Research Australia

    Nedlands, Western Australia, 06009

  • Calvary Mater Newcastle

    Waratah, New South Wales

  • Westmead Hospital

    Westmead, New South Wales

Other trials in Australia

Canada6 sites

  • Centricity Research

    Hailfax, Nova Scotia, B3S 1L8

  • Parkwood Institute Main Building

    London, Ontario, N6C0A7

  • True North Clinical Research Inc.

    New Minas, Nova Scotia, B4N 3R7

  • True North Clinical Research

    New Minas, Nova Scotia, B4N 3R7

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Spain5 sites

  • Barcelona Beta Brain Research Center (BBRC)

    Barcelona, 08005

  • Fundació ACE

    Barcelona, 08028

  • Fundacion CITA ALZHEIMER

    Donostia / San Sebastian, 20009

  • Hospital Universitario Quirón Salud Madrid

    Madrid, 28223

  • Hospital Universitario Marqués de Valdeciila

    Santander, 39008

Other trials in Spain

United Kingdom4 sites

  • Bristol Brain Centre

    Bristol, BS10 5NB

  • Glasgow Memory Clinic

    Glasgow, ML1 4UF

  • St Pancras Clinical Research

    London, EC2Y 8EA

  • Imperial Memory Unit

    London, W6 8RF

Other trials in United Kingdom

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

About this study

Official title: AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study With an Extension Phase to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer's Disease and Intermediate Amyloid (A3 Trial)

The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.

Being tested
Lecanemab, Placebo
Keywords
BAN2401, Preclinical Alzheimer's disease, Elevated amyloid, Early preclinical Alzheimer's disease, Intermediate amyloid, A45 Trial, A3 Trial, AHEAD 3-45, Lecanemab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LecanemabDrug

    Also called BAN2401

    IV infusion.

  • PlaceboDrug

    IV infusion.

Study groups in NCT04468659
Study groupRoleWhat they receive
A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study)ExperimentalParticipants will receive lecanemab 5 milligram per kilogram (mg/kg), administered as intravenous (IV) infusion, every two weeks from Week 0 to 6, then 10 mg/kg, administered as IV infusion, every two weeks from Week 8 to 94, and 10 mg/kg, administered as IV infusion, every four weeks from Week 96 to 216 in core study.
Receives: Drug: Lecanemab
A45 Trial: Placebo (Core Study)Placebo comparatorParticipants will receive placebo (0.9 percent [%] sodium chloride solution), administered as IV infusion, every two weeks from Week 0 to 94, then every four weeks from Week 96 to 216.
Receives: Drug: Placebo
A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study)ExperimentalParticipants will receive lecanemab 5 mg/kg, administered as IV infusion, every four weeks from Week 0 to 4, then 10 mg/kg, administered as IV infusion, every four weeks from Week 8 to 216 in core study.
Receives: Drug: Lecanemab
A3 Trial: Placebo (Core Study)Placebo comparatorParticipants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216.
Receives: Drug: Placebo
A3 and A45 Trial: Lecanemab 10 mg/kg (Extension Phase)ExperimentalParticipants (from either A3 or A45 Trial) progressing to early Alzheimer's disease (EAD) during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase for at least 216 weeks from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 5 mg/kg for initial 4 doses, than 10 mg/kg, administered as IV infusion, every two weeks for up to 96 weeks in extension phase.
Receives: Drug: Lecanemab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216

    PACC5(5 components):Free/cued selective reminding test:number of words recalled without cuing/with cuing(0[worst]-96[best recall]);Delayed Paragraph Recall test: recall of 1 short story(25 bits information),immediately after reading and again after delay of 30 minutes (0[worst]-25[best recall]);Digit-symbol substitution test: Participant uses a key to fill in blank squares as fast as possible in 90 seconds(0[none]-91[best performance]);Mini Mental State Score:to evaluate orientation,memory,attention,concentration,naming,repetition,comprehension and ability to create sentence,to copy 2 overlapping pentagons, scored as number of correctly completed items(0[worse]-30[perfect performance]);Category fluency task: participants generate words in 60 second belonging to a semantic category(total score:number of appropriate words generated per task, higher values indicate better performance).

    Measured: Baseline, Week 216

  2. A3 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216

    Measured: Baseline, Week 216

Secondary outcomes (4)

  1. A45 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216

    Measured: Baseline, Week 96, Week 216

  2. A45 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216

    Measured: Baseline, Week 96, Week 216

  3. A45 Trial: Change From Baseline in Cognitive Function Index (CFI) at Week 216

    CFI assessment to assess the participant's perceived ability to perform high-level functional tasks in daily life and sense of overall cognitive functional ability. Study participants (18 questions) and their study partners (15 questions) independently rate the participant's abilities. Total score combines participant and study partner scores, with higher scores indicating greater impairment.

    Measured: Baseline, Week 216

  4. A3 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216

    Measured: Baseline, Week 216

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start14 Jul 2020
  3. Primary completion21 Dec 2028 (estimated)
  4. Study completion16 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04468659
Sponsor's protocol ID
BAN2401-G000-303
Other IDs
R01AG054029, R01AG061848, 2020-004244-28
Status last verified
Jun 2026
First submitted
9 Jul 2020
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Publications

  • Devanarayan V, Doherty T, Charil A, Sachdev P, Ye Y, Murali LK, Llano DA, Zhou J, Reyderman L, Hampel H, Kramer LD, Dhadda S, Irizarry MC. Plasma pTau217 predicts continuous brain amyloid levels in preclinical and early Alzheimer's disease. Alzheimers Dement. 2024 Aug;20(8):5617-5628. doi: 10.1002/alz.14073. Epub 2024 Jun 28.

    PubMed 38940656

  • Molina-Henry DP, Raman R, Liu A, Langford O, Johnson K, Shum LK, Glover CM, Dhadda S, Irizarry M, Jimenez-Maggiora G, Braunstein JB, Yarasheski K, Venkatesh V, West T, Verghese PB, Rissman RA, Aisen P, Grill JD, Sperling RA. Racial and ethnic differences in plasma biomarker eligibility for a preclinical Alzheimer's disease trial. Alzheimers Dement. 2024 Jun;20(6):3827-3838. doi: 10.1002/alz.13803. Epub 2024 Apr 17.

    PubMed 38629508

  • Rissman RA, Langford O, Raman R, Donohue MC, Abdel-Latif S, Meyer MR, Wente-Roth T, Kirmess KM, Ngolab J, Winston CN, Jimenez-Maggiora G, Rafii MS, Sachdev P, West T, Yarasheski KE, Braunstein JB, Irizarry M, Johnson KA, Aisen PS, Sperling RA; AHEAD 3-45 Study team. Plasma Abeta42/Abeta40 and phospho-tau217 concentration ratios increase the accuracy of amyloid PET classification in preclinical Alzheimer's disease. Alzheimers Dement. 2024 Feb;20(2):1214-1224. doi: 10.1002/alz.13542. Epub 2023 Nov 6.

    PubMed 37932961

  • Kirn DR, Grill JD, Aisen P, Ernstrom K, Gale S, Heidebrink J, Jicha G, Jimenez-Maggiora G, Johnson L, Peskind E, McCann K, Shaffer E, Sultzer D, Wang S, Sperling R, Raman R. Centralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment. Alzheimers Res Ther. 2023 May 2;15(1):88. doi: 10.1186/s13195-023-01235-4.

    PubMed 37131229

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lecanemab in people with Preclinical Alzheimer's Disease and Early Preclinical Alzheimer's Disease, run by Eisai Inc. at 107 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Japan, Australia, Canada, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216 (time frame: Baseline, Week 216). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04468659, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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