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

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.

Study Overview

• Status: Recruiting
• Conditions: Preclinical Alzheimer's Disease; Early Preclinical Alzheimer's Disease
• Intervention / Treatment: Drug: Lecanemab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ACTC Recruitment Unit; Email: ahead-participate@usc.edu
• Study Contact Backup: Name: Eisai Medical Information; Phone Number: +1-888-274-2378; Email: esi_medinfo@eisai.com

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia
      • Recruiting
      • St Vincent'S Hospital Sydney
    • Waratah, New South Wales, Australia
      • Recruiting
      • Calvary Mater Newcastle
    • Westmead, New South Wales, Australia
      • Recruiting
      • Westmead Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Recruiting
      • CALHN Memory Trials
  • Victoria
    • Ivanhoe, Victoria, Australia
      • Recruiting
      • Austin Hospital - Medical and Cognitive Research Unit
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Australian Alzheimer's Research Foundation
• Canada
  • Nova Scotia
    • New Minas, Nova Scotia, Canada, B4N 3R7
      • Recruiting
      • True North Clinical Research Inc.
  • Ontario
    • London, Ontario, Canada, N6C0A7
      • Recruiting
      • Parkwood Institute Main Building
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M3B 2S7
      • Recruiting
      • Toronto Memory Program
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Withdrawn
      • McGill University / Jewish General Hospital Memory Clinic
• Japan
  • Aichi
    • Obu-shi, Aichi, Japan
      • Recruiting
      • Eisai Trial Site #2
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan
      • Recruiting
      • Eisai Trial Site #9
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Recruiting
      • Eisai Trial Site #13
  • Kanagawa
    • Kamakura-shi, Kanagawa, Japan
      • Recruiting
      • Eisai Trial Site #10
  • Kyoto
    • Kyoto-shi, Kyoto, Japan
      • Recruiting
      • Eisai Trial Site #11
  • Miyagi
    • Sendai-shi, Miyagi, Japan
      • Recruiting
      • Eisai Trial Site #5
  • Osaka
    • Osaka-shi, Osaka, Japan
      • Recruiting
      • Eisai Trial Site #6
    • Suita-shi, Osaka, Japan
      • Recruiting
      • Eisai Trial Site #12
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan
      • Recruiting
      • Eisai Trial Site #4
    • Hachioji -shi, Tokyo, Japan
      • Recruiting
      • Eisai Trial Site #1
    • Itabashi-ku, Tokyo, Japan
      • Recruiting
      • Eisai Trial Site #7
    • Kodaira-shi, Tokyo, Japan
      • Recruiting
      • Eisai Trial Site #8
    • Shinjuku-Ku, Tokyo, Japan
      • Recruiting
      • Eisai Trial Site #3
• Netherlands
  • Amsterdam, Netherlands, 01000
    • Recruiting
    • Brain Research Center
• Singapore
  • Singapore, Singapore
    • Recruiting
    • National University Hospital
• Spain
  • Barcelona, Spain, 08028
    • Recruiting
    • Fundació ACE
  • Barcelona, Spain, 08005
    • Recruiting
    • Barcelona Beta Brain Research Center
  • Madrid, Spain, 28223
    • Recruiting
    • Hospital Universitario Quiron Salud Madrid
  • San Sebastian, Spain, 20009
    • Recruiting
    • Fundacion CITA alzheimer
  • Santander, Spain, 39008
    • Recruiting
    • Hospital Universitario Marqués de Valdeciila
• Sweden
  • Malmo, Sweden, 21428
    • Not yet recruiting
    • Memory Clinic, Skåne University Hospital
  • Molndal, Sweden, 42830
    • Not yet recruiting
    • Memory Clinic Sahlgrenska University Hospital
  • Stockholm, Sweden, 14186
    • Not yet recruiting
    • Karolinska University Hospital
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Recruiting
    • Bristol Brain Centre
  • Glasgow, United Kingdom, ML1 4UF
    • Recruiting
    • Glasgow Memory Clinic
  • London, United Kingdom, EC2Y 8EA
    • Recruiting
    • St Pancras Clinical Research
  • London, United Kingdom, W6 8RF
    • Recruiting
    • Imperial Memory Unit
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama, Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Banner Alzheimer's Institute
    • Sun City, Arizona, United States, 85351
      • Recruiting
      • Banner Sun Health Research Institute
  • California
    • Irvine, California, United States, 92697-4285
      • Recruiting
      • UCI MIND
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Hoag Memorial Hospital Presbyterian
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
    • San Diego, California, United States, 92123
      • Recruiting
      • Sharp Mesa Vista Hospital
    • San Francisco, California, United States, 94158
      • Recruiting
      • Univeristy of California, San Francisco
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • University of California, Davis
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University School Of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Recruiting
      • Georgetown University
    • Washington, District of Columbia, United States, 20060
      • Recruiting
      • Howard University
  • Florida
    • Coral Gables, Florida, United States, 33134-1613
      • Recruiting
      • Advanced Clinical Research Network, Corp
    • Delray Beach, Florida, United States, 33445
      • Recruiting
      • Brain Matters Research
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Jacksonville
    • Maitland, Florida, United States, 32751
      • Recruiting
      • K2 Medical Research
    • Miami, Florida, United States, 33125
      • Recruiting
      • Gonzalez MD & Aswad MD Health Sciences
    • Miami Beach, Florida, United States, 33140
      • Recruiting
      • Wien Center for Clinical Research
    • Ocala, Florida, United States, 34470
      • Recruiting
      • Renstar Medical Research
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Synexus Clinical Research
    • Port Orange, Florida, United States, 32127
      • Recruiting
      • Progressive Medical Research
    • Tampa, Florida, United States, 33613
      • Recruiting
      • University of South Florida - Health Byrd Alzheimer Institute
    • The Villages, Florida, United States, 32162
      • Recruiting
      • Synexus Clinical Research
    • Wellington, Florida, United States, 33414
      • Recruiting
      • Alzheimer's Research and Treatment Center
    • Winter Park, Florida, United States, 31792
      • Recruiting
      • Charter Research
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Emory University
    • Columbus, Georgia, United States, 31909
      • Recruiting
      • Columbus Memory Center, PC
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University School of Medicine
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Recruiting
      • University of Kansas
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Recruiting
      • University of Kentucky
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston University
    • Boston, Massachusetts, United States, 21155
      • Recruiting
      • Brigham and Woman's Hospital Center for Alzheimer Research and Treatment
    • Plymouth, Massachusetts, United States, 02360
      • Recruiting
      • Donald S.Marks, M.D.,P.C.
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • University of Michigan (UMICH)
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic, Rochester
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Recruiting
      • Washington University
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Recruiting
      • Cleveland Clinic Lou Ruvo Center for Brain Health
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Recruiting
      • Advanced Memory Research Institute of New Jersey
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
    • Rochester, New York, United States, 14620
      • Recruiting
      • University of Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke Health Center
    • Matthews, North Carolina, United States, 28105
      • Recruiting
      • AMC Research
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Recruiting
      • Case Western Reserve University/University Hospitals
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Lou Ruvo Center for Brain Health
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Recruiting
      • Central States Research, LLC
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97210
      • Recruiting
      • Summit Research Network, Oregon
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Recruiting
      • Abington Neurological Associates
    • Norristown, Pennsylvania, United States, 19403
      • Recruiting
      • Keystone Clinical Studies, LLC
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • Butler Hospital Memory and Aging Program
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Withdrawn
      • Roper St. Francis Healthcare
    • Charleston, South Carolina, United States, 20403
      • Recruiting
      • Ralph H. Johnson VA Medical Center
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Withdrawn
      • Neurology Clinic, P.C.
    • Nashville, Tennessee, United States, 37212
      • Recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas, Southwestern MC at Dallas
    • Fort Worth, Texas, United States, 76107
      • Recruiting
      • University of North Texas Health Sciences Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Neurological Institute
    • San Antonio, Texas, United States, 78229-3900
      • Recruiting
      • The University of Texas Health Science Center at San Antonio
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Eastern Virginia Medical School
    • Richmond, Virginia, United States, 23294
      • Recruiting
      • National Clinical Research, Inc
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • University of Washington Memory and Brain Wellness Center
    • Seattle, Washington, United States, 98108
      • Recruiting
      • SIBCR
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study); Participants 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.	Drug: Lecanemab; IV infusion.; Other Names: BAN2401
Placebo Comparator: A45 Trial: Placebo (Core Study); Participants 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.	Drug: Placebo; IV infusion.
Experimental: A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study); Participants 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.	Drug: Lecanemab; IV infusion.; Other Names: BAN2401
Placebo Comparator: A3 Trial: Placebo (Core Study); Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216.	Drug: Placebo; IV infusion.
Experimental: A45 Trial: Lecanemab 10 mg/kg (Extension Phase); Participants 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 through to at least Week 216 from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks for up to Week 312. Eligible participants receiving placebo in core study will continue to extension phase.	Drug: Lecanemab; IV infusion.; Other Names: BAN2401
Experimental: A3 Trial: Lecanemab 10 mg/kg (Extension Phase); Participants progressing to 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 through to at least Week 216 from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks for up to Week 312. Eligible participants receiving placebo in core study will continue to extension phase.	Drug: Lecanemab; IV infusion.; Other Names: BAN2401

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Week 216
A3 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216		Baseline, Week 216

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A45 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216		Baseline, Week 96, Week 216
A45 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216		Baseline, Week 96, Week 216
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.	Baseline, Week 216
A3 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216		Baseline, Week 216

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: National Institute on Aging (NIA); Biogen; Alzheimer's Clinical Trials Consortium

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Estimated): February 15, 2029
• Study Completion (Estimated): February 15, 2029

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: BAN2401; Lecanemab; Preclinical Alzheimer's disease; Elevated amyloid; Early preclinical Alzheimer's disease; Intermediate amyloid; A45 Trial; A3 Trial; AHEAD 3-45
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Proteostasis Deficiencies; Dementia; Tauopathies; Amyloidosis; Alzheimer Disease
• Other Study ID Numbers: BAN2401-G000-303; R01AG054029 (U.S. NIH Grant/Contract); R01AG061848 (U.S. NIH Grant/Contract); 2020-004244-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No