A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease
A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study With an Open-Label Extension Phase to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
2 other identifiers
interventional
856
11 countries
169
Brief Summary
This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy and to explore the dose response of lecanemab using a composite clinical score (ADCOMS). BAN2401-G000-201 Core study is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly (once every 4 weeks) to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint. Any participant who completes the study treatment (Visit 42 \[Week 79\] of the Core study) or discontinues the Core Study will be eligible to participate in the Extension Phase, provided they meet the Extension Phase inclusion and exclusion criteria. Participants will receive 10 mg/kg biweekly for up to 60 months or until the drug is commercially available in the country, where the subject resides, or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. The Follow-up Visit in the Extension Phase will take place 3 months after the last dose of study drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
Longer than P75 for phase_2
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2012
CompletedFirst Submitted
Initial submission to the registry
January 8, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2024
CompletedResults Posted
Study results publicly available
March 4, 2026
CompletedMarch 4, 2026
January 1, 2026
12 years
January 8, 2013
December 10, 2025
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Core Study Phase: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at Month 12
The ADCOMS is a composite score that comprises 4/14 items from the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), 2 items from the Mini Mental State Examination (MMSE), and all items from the Clinical Dementia Rating (CDR). Composite score is derived from the variables from the 12 items, and ranges from 0 to 1.97, where higher score means greater impairment. Change from baseline was analyzed using Bayesian analysis. Data presented are posterior mean and posterior standard deviation.
Core Study Phase: at Month 12
Core Study Phase: Number of Participants With All Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE is defined as an AE that emerged during treatment or within 90 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
From first dose of the study drug (Week 1) up to 90 days after last dose of study drug (up to 21 months)
OLE Phase: Number of Participants With All TEAEs and SAEs
A TEAE is defined as an AE that emerged during treatment or within 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening (that is, the participant is at immediate risk of death from the adverse event as it occurs, this does not include an event that, has it occurred in a more severe form or is allowed to continue, might have cause death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect (in the child of a participant who is exposed to the study drug).
From first dose of the study drug (Week 1) up to 30 days after last dose of study drug (up to 61 months)
Secondary Outcomes (12)
Core Study Phase: Change From Baseline at Months 12 and 18 in Brain Amyloid Pathophysiology as Measured by Amyloid Positron Emission Tomography (PET)
Core Study Phase: at Months 12 and 18
Core Study Phase: Change From Baseline in ADCOMS at Month 18
Core Study Phase: at Month 18
Core Study Phase: Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at Months 12 and 18
Core Study Phase: at Months 12 and 18
Core Study Phase: Change From Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at Months 12 and 18
Core Study Phase: at Months 12 and 18
Core Study Phase: Change From Baseline in Cerebrospinal Fluid (CSF) Biomarker Levels at Months 12 and 18
Core Study Phase: at Months 12 and 18
- +7 more secondary outcomes
Study Arms (7)
Core Study: Lecanemab 2.5 mg/kg biweekly
EXPERIMENTAL2.5 mg/kg biweekly
Core Study: Lecanemab 5.0 mg/kg biweekly
EXPERIMENTAL5.0 mg/kg biweekly
Core Study: Lecanemab 10 mg/kg biweekly
EXPERIMENTAL10 mg/kg biweekly
Core Study: Lecanemab 5.0 mg/kg monthly
EXPERIMENTAL5.0 mg/kg monthly
Core Study: Lecanemab 10 mg/kg monthly
EXPERIMENTAL10 mg/kg monthly
Core Study: Lecanemab-matched Placebo
PLACEBO COMPARATORMatching placebo biweekly
Extension Phase: Lecanemab 10 mg/kg
EXPERIMENTALAll participants who fulfill Extension Phase inclusion and exclusion criteria will have the option to participate in the Extension Phase to receive lecanemab 10 mg/kg biweekly for up to 60 months or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. Additionally, participants who have received Extension Phase treatment for at least 18 months may opt to enter the dosing regimen substudy during which they will receive either lecanemab 10 mg/kg once every 4 weeks (Q4W) or once every 3 months (Q3M).
Interventions
2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
biweekly (once every 2 weeks) administered as i.v. infusion
Eligibility Criteria
You may qualify if:
- \- Intermediate likelihood:
- Subjects who meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment due to Alzheimer's disease - intermediate likelihood
- Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline
- Subjects who report a history of subjective memory decline with gradual onset and slow progression over the last one year before Screening; MUST be corroborated by an informant
- Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
- Subjects who have a CDR score of 0.5-1.0 and a Memory Box score of 0.5 or greater at Screening and Baseline
- Subjects with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale - IV Logical Memory II (WMS-IV LMII):
- Less than or equal to 15 for age 50 to 64 years
- Less than or equal to 12 for age 65 to 69 years
- Less than or equal to 11 for age 70 to 74 years
- Less than or equal to 9 for age 75 to 79 years
- Less than or equal to 7 for age 80 to 90 years
- Positive amyloid load as indicated by PET or CSF assessment
- PET assessment of imaging agent uptake into brain
- CSF assessment of Aβ(1-42)
- +16 more criteria
You may not qualify if:
- Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD
- History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
- Any psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
- Geriatric Depression Scale (GDS) score ≥8 at Screening
- Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator, ferromagnetic metal implants, e,g., in skull and cardiac devices other than those approved as safe for use in MR scanners
- Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening, or other significant pathological findings on brain MRI at Screening
- A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated electrocardiogram (ECG)
- Certain other specified medical conditions
- Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately
- Subjects who discontinued from the study drug or from the Core Study for reasons other than the following:
- ARIA-E
- ARIA-H (superficial siderosis, macrohemorrhage, or symptomatic microhemorrhage)
- Prohibited or restricted medications that were prohibited during Core Study conduct but are no longer prohibited in the Extension Phase
- Subjects who were APOE4 positive and receiving treatment with lecanemab 10 mg/kg biweekly
- AE that was considered not related to study drug, and that was not severe or life-threatening
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
- Biogencollaborator
Study Sites (169)
Facility #1
Birmingham, Alabama, 35294, United States
Facility #1
Phoenix, Arizona, 85004, United States
Facility #1
Tucson, Arizona, 85724, United States
Facility #1
Carson, California, 90746, United States
Facility #1
Lomita, California, 90717, United States
Facility #1
Long Beach, California, 90806, United States
Facility #1
Los Alamitos, California, 90720, United States
Facility #1
Los Angeles, California, 90024, United States
Facility #2
Los Angeles, California, 90024, United States
Facility #3
Los Angeles, California, 90024, United States
Facility #1
Orange, California, United States
Facility #1
Oxnard, California, 93030, United States
Facility #1
San Diego, California, 92123, United States
Facility #1
Denver, Colorado, 80239-3133, United States
Facility #1
New Haven, Connecticut, 06510, United States
Facility #2
New Haven, Connecticut, 06510, United States
Facility #1
Atlantis, Florida, 33462, United States
Facility #1
Boca Raton, Florida, 33431, United States
Facility #2
Boca Raton, Florida, 33486, United States
Facility #1
Bradenton, Florida, 34205, United States
Facility #1
Deerfield Beach, Florida, 33064, United States
Facility #1
Delray Beach, Florida, 33445, United States
Facility #1
Fort Myers, Florida, 33912, United States
Facility #1
Hallandale, Florida, 33009, United States
Facility #1
Hialeah, Florida, 33016, United States
Facility #1
Lake Worth, Florida, 33449, United States
Facility #1
Leesburg, Florida, 34748, United States
Facility #2
Leesburg, Florida, 34749, United States
Facility #1
Miami, Florida, 33133, United States
Facility #2
Miami, Florida, 33137, United States
Facility #3
Miami, Florida, 33145, United States
Facility #1
Miami Springs, Florida, 33166, United States
Facility #1
Naples, Florida, 34102, United States
Facility #1
Ocala, Florida, 34471, United States
Facility #1
Orlando, Florida, 32806, United States
Facility #1
Palm Beach Gardens, Florida, 33410, United States
Facility #1
St. Petersburg, Florida, 33713, United States
Facility #1
Sunrise, Florida, 33351, United States
Facility #3
Tampa, Florida, 33609, United States
Facility #1
Tampa, Florida, 33613, United States
Facility #2
Tampa, Florida, 33613, United States
Facility #1
The Villages, Florida, United States
Facility #2
Atlanta, Georgia, 30308, United States
Facility #1
Atlanta, Georgia, 30329, United States
Facility #1
Columbus, Georgia, 31909, United States
Facility #1
Decatur, Georgia, 30033, United States
Facility #1
Chicago, Illinois, 60640, United States
Facility #1
Elk Grove Village, Illinois, 60007, United States
Facility #1
Elkhart, Indiana, 46514, United States
Facility #1
Indianapolis, Indiana, 46202, United States
Facility #1
Wichita, Kansas, 67214, United States
Facility #1
Lexington, Kentucky, 40504, United States
Facility #1
Boston, Massachusetts, 02115, United States
Facility #2
Boston, Massachusetts, 02118, United States
Facility #1
Burlington, Massachusetts, 01805, United States
Facility #1
Newton, Massachusetts, 02459, United States
Facility #1
Ann Arbor, Michigan, 48105-2945, United States
Facility #1
East Lansing, Michigan, United States
Facility #1
Farmington Hills, Michigan, 48334, United States
Facility #1
Lansing, Michigan, 48824, United States
Facility #1
West Bloomfield, Michigan, 48322, United States
Facility #1
St Louis, Missouri, 63118, United States
Facility #1
Eatontown, New Jersey, 07724, United States
Facility #1
Toms River, New Jersey, 08755, United States
Facility #1
Albany, New York, 12206, United States
Facility #1
Amherst, New York, 14226, United States
Facility #1
Latham, New York, 12110, United States
Facility #1
New York, New York, 10016, United States
Facility #2
New York, New York, 10021, United States
Facility #1
Rochester, New York, 14620, United States
Facility #2
Rochester, New York, 14623, United States
Facility #1
Charlotte, North Carolina, 28211, United States
Facility #1
Centerville, Ohio, 45459, United States
Facility #1
Oklahoma City, Oklahoma, 73112, United States
Facility #2
Oklahoma City, Oklahoma, 73116, United States
Facility #2
Portland, Oregon, 97210, United States
Facility #1
Portland, Oregon, 97239, United States
Facility #1
Abington, Pennsylvania, 19001, United States
Facility #1
Jenkintown, Pennsylvania, 19046, United States
Facility #1
East Providence, Rhode Island, 02914, United States
Facility #1
Knoxville, Tennessee, 37920, United States
Facility #1
Austin, Texas, 78757, United States
Facility #1
Dallas, Texas, 75214, United States
Facility #2
Dallas, Texas, United States
Facility #1
Houston, Texas, 77074, United States
Facility #1
San Antonio, Texas, 78229, United States
Facility #2
San Antonio, Texas, 78229, United States
Facility #3
San Antonio, Texas, 78229, United States
Facility #1
Bennington, Vermont, 05201, United States
Facility #1
Richmond, Virginia, 23294, United States
Facility #1
Milwaukee, Wisconsin, 53226, United States
Facility #1
Kentville, Nova Scotia, Canada
Facility #1
Kingston, Ontario, Canada
Facility #2
London, Ontario, Canada
Facility #1
Ottawa, Ontario, Canada
Facility #1
Peterborough, Ontario, Canada
Facility #1
Toronto, Ontario, Canada
Facility #1
Greenfield Park, Quebec, Canada
Facility #1
Montreal, Quebec, Canada
Facility #1
Verdun, Quebec, Canada
Facility #1
Québec, Canada
Facility #1
Strasbourg, Bas Rhin, France
Facility #1
Toulouse, Haute Garonne, France
Facility #1
Paris, Paris, France
Facility #1
Bron, France
Facility #1
Paris, France
Facility #1
Rennes, France
Facility #1
Villeurbanne, France
Facility #1
Gunzburg, Baden-Wurttemberg, Germany
Facility #1
Karlstadt am Main, Bavaria, Germany
Facility #1
Hanover, Lower Saxony, Germany
Facility #1
Mittweida, Saxony, Germany
Facility #1
Hoppegarten, State of Berlin, Germany
Facility #1
Berlin, Germany
Facility #2
Berlin, Germany
Facility #3
Berlin, Germany
Facility #1
Günzburg, Germany
Facility #1
Hamburg, Germany
Facility #1
Heidelberg, Germany
Facility #1
Leipzig, Germany
Facility #1
Mannheim, Germany
Facility #1
München, Germany
Facility #1
Tübingen, Germany
Facility #1
Brescia, Italy
Facility #1
Genova, Italy
Facility #1
Milan, Italy
Facility #1
Parma, Italy
Facility #1
Perugia, Italy
Facility #1
Pisa, Italy
Facility #1
Roma, Italy
Facility #2
Roma, Italy
Facility #3
Roma, Italy
Eisai Trial Site #1
Otake-shi, Hiroshima, Japan
Eisai Trial Site #1
Himeji-shi, Hyōgo, Japan
Eisai Trial Site #2
Himeji-shi, Hyōgo, Japan
Eisai Trial Site #3
Himeji-shi, Hyōgo, Japan
Eisai Trial Site #1
Kobe, Hyōgo, Japan
Eisai Trial Site #1
Nishinomiya-shi, Hyōgo, Japan
Eisai Trial Site #1
Kyoto, Kyoto, Japan
Eisai Trial Site #1
Kurashiki-shi, Okayama-ken, Japan
Eisai Trial Site #1
Osaka, Osaka, Japan
Eisai Trial Site #1
Saitama-shi, Saitama, Japan
Eisai Trial Site #1
Itabashi-ku, Tokyo-To, Japan
Eisai Trial Site #1
Shinjuku-ku, Tokyo-To, Japan
Eisai Trial Site #2
Shinjuku-ku, Tokyo-To, Japan
Facility #1
Amsterdam, Netherlands
Facility #1
Seongnam-si, Gyeonggi-do, South Korea
Facility #1
Pusan, Gyeongsangnam-do, South Korea
Facility #2
Seoul, South Korea
Facility #3
Seoul, South Korea
Facility #4
Seoul, South Korea
Facility #1
Sant Cugat Del Vallés, Barcelona, Spain
Facility #1
Donostia / San Sebastian, Guipuzcoa, Spain
Facility #1
Barakaldo, Vizcaya, Spain
Facility #1
Alicante, Spain
Facility #1
Barcelona, Spain
Facility #1
Madrid, Spain
Facility #2
Madrid, Spain
Facility #1
Seville, Spain
Facility #1
Malmo, Sweden
Facility #1
Mölndal, Sweden
Facility #1
Stockholm, Sweden
Facility #1
Uppsala, Sweden
Facility #1
London, Greater London, United Kingdom
Facility #1
Isleworth, Middlesex, United Kingdom
Facility #1
Glasgow, Renfrewshire, United Kingdom
Facility #1
Bath, United Kingdom
Facility #2
London, United Kingdom
Facility #1
Swindon, United Kingdom
Related Publications (5)
Devanarayan V, Ye Y, Charil A, Andreozzi E, Sachdev P, Llano DA, Tian L, Zhu L, Hampel H, Kramer L, Dhadda S, Irizarry M; Alzheimer's Disease Neuroimaging Initiative (ADNI). Predicting clinical progression trajectories of early Alzheimer's disease patients. Alzheimers Dement. 2024 Mar;20(3):1725-1738. doi: 10.1002/alz.13565. Epub 2023 Dec 13.
PMID: 38087949DERIVEDBerry DA, Dhadda S, Kanekiyo M, Li D, Swanson CJ, Irizarry M, Kramer LD, Berry SM. Lecanemab for Patients With Early Alzheimer Disease: Bayesian Analysis of a Phase 2b Dose-Finding Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e237230. doi: 10.1001/jamanetworkopen.2023.7230.
PMID: 37040116DERIVEDMcDade E, Cummings JL, Dhadda S, Swanson CJ, Reyderman L, Kanekiyo M, Koyama A, Irizarry M, Kramer LD, Bateman RJ. Lecanemab in patients with early Alzheimer's disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alzheimers Res Ther. 2022 Dec 21;14(1):191. doi: 10.1186/s13195-022-01124-2.
PMID: 36544184DERIVEDDhadda S, Kanekiyo M, Li D, Swanson CJ, Irizarry M, Berry S, Kramer LD, Berry DA. Consistency of efficacy results across various clinical measures and statistical methods in the lecanemab phase 2 trial of early Alzheimer's disease. Alzheimers Res Ther. 2022 Dec 9;14(1):182. doi: 10.1186/s13195-022-01129-x.
PMID: 36482412DERIVEDSwanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RYK, Lannfelt L, Bradley H, Rabe M, Koyama A, Reyderman L, Berry DA, Berry S, Gordon R, Kramer LD, Cummings JL. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Abeta protofibril antibody. Alzheimers Res Ther. 2021 Apr 17;13(1):80. doi: 10.1186/s13195-021-00813-8.
PMID: 33865446DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eisai Medical Information
- Organization
- Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2013
First Posted
January 14, 2013
Study Start
December 20, 2012
Primary Completion
December 10, 2024
Study Completion
December 10, 2024
Last Updated
March 4, 2026
Results First Posted
March 4, 2026
Record last verified: 2026-01