A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Early Alzheimer's Disease

In brief

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.

Key facts

Study ID

NCT03887455

Run by

Eisai Inc.

People needed

1906

Starts

2019-03-27

Expected to finish

2029-06-30

Last updated by the study team

2026-04-07

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease
• History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
• Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant
• Geriatric Depression Scale (GDS) score >=8 at Screening
• Contraindications to 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)
• Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than Alzheimer's disease
• Other significant pathological findings on brain MRI at screening, including but not limited to: more than 4 microhemorrhages (defined as 10 millimeter [mm] or less at the greatest diameter); a single macrohemorrhage >10 mm at greatest diameter; an area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and <1 centimeter [cm] at their greatest diameter need not be exclusionary)
• 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
• Participants with a bleeding disorder that is not under adequate control (including a platelet count <50,000 or international normalized ratio [INR] >1.5 for participants who are not on anticoagulant treatment, example, warfarin). Participants who are on anticoagulant therapy should have their anticoagulant status optimized and be on a stable dose for 4 weeks before Screening. Participants who are on anticoagulant therapy are not permitted to participate in cerebrospinal fluid (CSF) assessments
• Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
• Participation in a clinical study involving any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within 6 months before screening unless it can be documented that the participant was randomized to placebo
• Participation in a clinical study involving any anti-amyloid therapies (including any monoclonal antibody therapies and any β-site amyloid precursor protein cleaving enzyme [BACE] inhibitor therapies) unless it can be documented that the participant only received placebo
• Participants who have any known prior exposure to lecanemab
• Participants who were dosed in a clinical study involving any new chemical entities for AD within 6 months prior to screening unless it can be documented that the participant was in a placebo treatment arm
• Extension Phase: Exclusion Criteria
• Participants who discontinued early from the Core Study
• Participants who develop the following conditions from the time of Screening for the Core Study to the start of the Extension Phase
• Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
• Any psychiatric diagnosis or symptoms, (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant
• Contraindications to 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)
• Other significant pathological findings on brain MRI during the Core Study including but not limited to: cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors will be exclusionary if based on the opinion of the investigator, with consultation of medical monitor, these findings may interfere with the study procedures or safety
• Hypersensitivity to BAN2401 or any of the excipients, or to any monoclonal antibody treatment
• Any immunological disease which is not adequately controlled, or which requires chronic treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study
• Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG, which in the opinion of the investigator require further investigation or treatment or which may interfere with study procedures or safety
• Malignant neoplasms (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male participants) that are not stably and adequately controlled or which, based on the opinion of the investigator, may interfere with the participant's safety or participation in the study

Where it is running

• Banner Sun Health Research — Sun City, Arizona, United States
• Neurological Associates of Tucson dba Center for Neurosciences — Tucson, Arizona, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Irvine Clinical Research — Irvine, California, United States
• University of California - Los Angeles — Los Angeles, California, United States
• Pacific Neuroscience Medical Group — Oxnard, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Pacific Research Network, Inc — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• UCSF Memory and Aging Center — San Francisco, California, United States
• Apex Research Institute — Santa Ana, California, United States
• St Joseph Heritage Healthcare — Santa Rosa, California, United States
• North Bay Neuroscience Research Institute — Sebastopol, California, United States
• ImmunoE Research Center — Centennial, Colorado, United States
• Mile High Research Center — Denver, Colorado, United States
• Associated Neurologists of Southern Connecticut — Fairfield, Connecticut, United States
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• JEM Research Institute — Atlantis, Florida, United States
• Bradenton Research Center, Inc. — Bradenton, Florida, United States
• Advanced Clinical Research Network — Coral Gables, Florida, United States
• Linfritz Research Institute, Inc. — Coral Gables, Florida, United States
• Banner Alzheimer's Institute- Clinical Trials Department — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.