New antibody shows promise in slowing Alzheimer's decline

NCT ID NCT01767311

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

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called lecanemab (BAN2401) in 856 people with early Alzheimer's disease, including those with mild cognitive impairment or mild dementia. Participants received different doses of the drug or a placebo every 2 or 4 weeks for 18 months. The goal was to see if lecanemab could slow cognitive decline and reduce amyloid plaques in the brain. Results suggested the drug may help slow disease progression, but side effects like brain swelling were observed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Lecanemab (also known as BAN2401), an antibody given by IV infusion
What this could lead to: If it works, this could lead to a treatment that slows memory loss and cognitive decline in people with early Alzheimer's disease.
What could go wrong: This is a Phase 2 trial, so results are still early. The drug may not work for everyone, and side effects like brain swelling or bleeding can occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

856 people

The number who actually took part.

Started

Dec 2012

Finished

Dec 2024

Lead sponsor

A company

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

Who can take part

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

Ages

50 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

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

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria (Core Study) for Mild Cognitive Impairment due to Alzheimer's Disease \- Intermediate likelihood: 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 Key Inclusion Criteria (Core Study) for Mild Alzheimer's Disease Dementia: 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 Inclusion Criteria (Core Study) that must be met by all subjects: 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 Inclusion Criteria (Extension Phase): 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 Key Exclusion Criteria (Core study): 1. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD 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 Exclusion Criteria (Extension Phase): 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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

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

Alzheimer's disease

Contacts and locations

Locations

Eisai Trial Site #1

Otake-shi, Hiroshima, Japan
Eisai Trial Site #1

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

Himeji-shi, Hyōgo, Japan
Eisai Trial Site #2

Shinjuku-ku, Tokyo-To, Japan
Eisai Trial Site #3

Himeji-shi, Hyōgo, Japan
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 #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 #1

Atlantis, Florida, 33462, United States
Facility #1

Boca Raton, Florida, 33431, 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 #1

Miami, Florida, 33133, 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 #1

Tampa, Florida, 33613, United States
Facility #1

The Villages, Florida, 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 #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 #1

Rochester, New York, 14620, 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 #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 #1

Houston, Texas, 77074, United States
Facility #1

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 #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 #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 #1

Amsterdam, Netherlands
Facility #1

Seongnam-si, Gyeonggi-do, South Korea
Facility #1

Pusan, Gyeongsangnam-do, 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 #1

Seville, Spain
Facility #1

Malmö, 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 #1

Swindon, United Kingdom
Facility #2

Los Angeles, California, 90024, United States
Facility #2

New Haven, Connecticut, 06510, United States
Facility #2

Boca Raton, Florida, 33486, United States
Facility #2

Leesburg, Florida, 34749, United States
Facility #2

Miami, Florida, 33137, United States
Facility #2

Tampa, Florida, 33613, United States
Facility #2

Atlanta, Georgia, 30308, United States
Facility #2

Boston, Massachusetts, 02118, United States
Facility #2

New York, New York, 10021, United States
Facility #2

Rochester, New York, 14623, United States
Facility #2

Oklahoma City, Oklahoma, 73116, United States
Facility #2

Portland, Oregon, 97210, United States
Facility #2

Dallas, Texas, United States
Facility #2

San Antonio, Texas, 78229, United States
Facility #2

London, Ontario, Canada
Facility #2

Berlin, Germany
Facility #2

Roma, Italy
Facility #2

Seoul, South Korea
Facility #2

Madrid, Spain
Facility #2

London, United Kingdom
Facility #3

Los Angeles, California, 90024, United States
Facility #3

Miami, Florida, 33145, United States
Facility #3

Tampa, Florida, 33609, United States
Facility #3

San Antonio, Texas, 78229, United States
Facility #3

Berlin, Germany
Facility #3

Roma, Italy
Facility #3

Seoul, South Korea
Facility #4

Seoul, South Korea

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