A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease
NCT ID: NCT01767311
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
856 participants
INTERVENTIONAL
2012-12-20
2024-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Core Study: Lecanemab 2.5 mg/kg biweekly
2.5 mg/kg biweekly
Lecanemab 2.5 mg/kg
2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
Core Study: Lecanemab 5.0 mg/kg biweekly
5.0 mg/kg biweekly
Lecanemab 5.0 mg/kg
5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
Core Study: Lecanemab 10 mg/kg biweekly
10 mg/kg biweekly
Lecanemab 10 mg/kg
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
Core Study: Lecanemab 5.0 mg/kg monthly
5.0 mg/kg monthly
Lecanemab 5.0 mg/kg
5.0 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
Core Study: Lecanemab 10 mg/kg monthly
10 mg/kg monthly
Lecanemab 10 mg/kg
10 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
Core Study: Lecanemab-matched Placebo
Matching placebo biweekly
Placebo
biweekly (once every 2 weeks) administered as i.v. infusion
Extension Phase: Lecanemab 10 mg/kg
All 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).
Lecanemab 10 mg/kg
10 mg/kg biweekly (once every 2 weeks), once every 4 weeks (Q4W) or once every 3 months (Q3M) i.v. infusion.
Interventions
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Lecanemab 2.5 mg/kg
2.5 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
Lecanemab 5.0 mg/kg
5.0 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion
Lecanemab 10 mg/kg
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.
Lecanemab 5.0 mg/kg
5.0 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
Lecanemab 10 mg/kg
10 mg/kg monthly (once every 4 weeks) administered as i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
Placebo
biweekly (once every 2 weeks) administered as i.v. infusion
Lecanemab 10 mg/kg
10 mg/kg biweekly (once every 2 weeks), once every 4 weeks (Q4W) or once every 3 months (Q3M) i.v. infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. 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
2. Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline
3. 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
1. Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
2. 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
1. 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):
1. Less than or equal to 15 for age 50 to 64 years
2. Less than or equal to 12 for age 65 to 69 years
3. Less than or equal to 11 for age 70 to 74 years
4. Less than or equal to 9 for age 75 to 79 years
5. Less than or equal to 7 for age 80 to 90 years
2. Positive amyloid load as indicated by PET or CSF assessment
1. PET assessment of imaging agent uptake into brain
2. CSF assessment of Aβ(1-42)
3. Age between 50 and 90 years, inclusive
4. Mini Mental State Examination (MMSE) score equal to or greater than 22, and equal to or less than 30, at Screening and Baseline
5. Body Mass Index (BMI) greater than 17 and less than 35 at Screening or Baseline
6. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin assay \[ß-hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
7. Subjects on acetylcholinesterase inhibitor or memantine therapy or both for AD must be on a stable dose for at least 12 weeks prior to Baseline. Treatment naive subjects can be entered into the study. Unless otherwise stated, subjects must have been on stable doses of all other permitted concomitant medications (ie, non-AD related) for at least 4 weeks prior to Baseline.
8. Subjects must have identified caregivers/informants
9. Subjects must provide written informed consent
1. Subjects who have completed Visit 42 (Week 79) of the Core Study or who discontinued study drug during the Core Study due to any of the following reasons:
1. Alzheimer's Related Imaging Abnormality-Edema (ARIA-E)
2. Amyloid related imaging abnormality hemorrhage (ARIA-H) (superficial siderosis, macrohemorrhage, or symptomatic microhemorrhage)
3. Prohibited or restricted medications that were prohibited during Core Study conduct but are no longer prohibited in the Extension Phase
4. Subjects who were APOE4 positive and receiving treatment with lecanemab 10 mg/kg biweekly
5. Any reason for discontinuation not related to prohibited medications, including any AE that was considered not related to study drug, and that was not severe or life-threatening
2. Must continue to have an identified caregiver or informant who is willing and able to provide follow-up information on the subject throughout the course of the Extension Phase
3. Provide written informed consent. If a subject lacks capacity to consent in the investigator's opinion, the subject's assent should be obtained, if required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations).
4. Must be able to physically attend clinic visits and be willing and able to comply with all aspects of the protocol
Exclusion Criteria
2. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
3. Any psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
4. Geriatric Depression Scale (GDS) score ≥8 at Screening
5. 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
6. 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
7. A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated electrocardiogram (ECG)
8. Certain other specified medical conditions
9. Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately
1. Subjects who discontinued from the study drug or from the Core Study for reasons other than the following:
1. ARIA-E
2. ARIA-H (superficial siderosis, macrohemorrhage, or symptomatic microhemorrhage)
3. Prohibited or restricted medications that were prohibited during Core Study conduct but are no longer prohibited in the Extension Phase
4. Subjects who were APOE4 positive and receiving treatment with lecanemab 10 mg/kg biweekly
5. AE that was considered not related to study drug, and that was not severe or life-threatening
2. Females of childbearing potential who do not agree to use a highly effective method of contraception
3. Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately.
50 Years
90 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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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
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Malmo, , Sweden
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Mölndal, , Sweden
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Stockholm, , Sweden
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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
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
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Hamburg, , Germany
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Heidelberg, , Germany
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Leipzig, , Germany
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Mannheim, , Germany
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München, , Germany
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Tübingen, , Germany
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Brescia, , Italy
Facility #1
Genova, , Italy
Facility #1
Milan, , Italy
Facility #1
Parma, , Italy
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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
Birmingham, Alabama, United States
Facility #1
Phoenix, Arizona, United States
Facility #1
Tucson, Arizona, United States
Facility #1
Carson, California, United States
Facility #1
Lomita, California, United States
Facility #1
Long Beach, California, United States
Facility #1
Los Alamitos, California, United States
Facility #1
Los Angeles, California, United States
Facility #2
Los Angeles, California, United States
Facility #3
Los Angeles, California, United States
Facility #1
Orange, California, United States
Facility #1
Oxnard, California, United States
Facility #1
San Diego, California, United States
Facility #1
Denver, Colorado, United States
Facility #1
New Haven, Connecticut, United States
Facility #2
New Haven, Connecticut, United States
Facility #1
Atlantis, Florida, United States
Facility #1
Boca Raton, Florida, United States
Facility #2
Boca Raton, Florida, United States
Facility #1
Bradenton, Florida, United States
Facility #1
Deerfield Beach, Florida, United States
Facility #1
Delray Beach, Florida, United States
Facility #1
Fort Myers, Florida, United States
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Hallandale, Florida, United States
Facility #1
Hialeah, Florida, United States
Facility #1
Lake Worth, Florida, United States
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Leesburg, Florida, United States
Facility #2
Leesburg, Florida, United States
Facility #1
Miami, Florida, United States
Facility #2
Miami, Florida, United States
Facility #3
Miami, Florida, United States
Facility #1
Miami Springs, Florida, United States
Facility #1
Naples, Florida, United States
Facility #1
Ocala, Florida, United States
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Orlando, Florida, United States
Facility #1
Palm Beach Gardens, Florida, United States
Facility #1
St. Petersburg, Florida, United States
Facility #1
Sunrise, Florida, United States
Facility #3
Tampa, Florida, United States
Facility #1
Tampa, Florida, United States
Facility #2
Tampa, Florida, United States
Facility #1
The Villages, Florida, United States
Facility #2
Atlanta, Georgia, United States
Facility #1
Atlanta, Georgia, United States
Facility #1
Columbus, Georgia, United States
Facility #1
Decatur, Georgia, United States
Facility #1
Chicago, Illinois, United States
Facility #1
Elk Grove Village, Illinois, United States
Facility #1
Elkhart, Indiana, United States
Facility #1
Indianapolis, Indiana, United States
Facility #1
Wichita, Kansas, United States
Facility #1
Lexington, Kentucky, United States
Facility #1
Boston, Massachusetts, United States
Facility #2
Boston, Massachusetts, United States
Facility #1
Burlington, Massachusetts, United States
Facility #1
Newton, Massachusetts, United States
Facility #1
Ann Arbor, Michigan, United States
Facility #1
East Lansing, Michigan, United States
Facility #1
Farmington Hills, Michigan, United States
Facility #1
Lansing, Michigan, United States
Facility #1
West Bloomfield, Michigan, United States
Facility #1
St Louis, Missouri, United States
Facility #1
Eatontown, New Jersey, United States
Facility #1
Toms River, New Jersey, United States
Facility #1
Albany, New York, United States
Facility #1
Amherst, New York, United States
Facility #1
Latham, New York, United States
Facility #1
New York, New York, United States
Facility #2
New York, New York, United States
Facility #1
Rochester, New York, United States
Facility #2
Rochester, New York, United States
Facility #1
Charlotte, North Carolina, United States
Facility #1
Centerville, Ohio, United States
Facility #1
Oklahoma City, Oklahoma, United States
Facility #2
Oklahoma City, Oklahoma, United States
Facility #2
Portland, Oregon, United States
Facility #1
Portland, Oregon, United States
Facility #1
Abington, Pennsylvania, United States
Facility #1
Jenkintown, Pennsylvania, United States
Facility #1
East Providence, Rhode Island, United States
Facility #1
Knoxville, Tennessee, United States
Facility #1
Austin, Texas, United States
Facility #1
Dallas, Texas, United States
Facility #2
Dallas, Texas, United States
Facility #1
Houston, Texas, United States
Facility #1
San Antonio, Texas, United States
Facility #2
San Antonio, Texas, United States
Facility #3
San Antonio, Texas, United States
Facility #1
Bennington, Vermont, United States
Facility #1
Richmond, Virginia, United States
Facility #1
Milwaukee, Wisconsin, 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
Countries
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References
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Berry 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.
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.
McDade 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.
Dhadda 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.
Swanson 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.
Other Identifiers
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2012-002843-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BAN2401-G000-201
Identifier Type: -
Identifier Source: org_study_id
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