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Study of Lecanemab (BAN2401) Treatment in People with Early Alzheimer's Disease: Testing Safety and Effectiveness Over 18 Months

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on testing a medication called lecanemab (also known as BAN2401) in people with Early Alzheimer's Disease. This condition includes both mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia, which causes gradual memory decline and difficulties with daily activities. The purpose is to determine if the medication can help slow down the progression of early-stage Alzheimer's disease symptoms.

The study medication lecanemab is given through intravenous infusion, which means it is delivered directly into the bloodstream through a vein. Some participants will receive the actual medication while others will receive a placebo. The study consists of two parts: an 18-month main phase followed by an extension phase where all participants can receive the actual medication.

During the study, participants will receive regular infusions of either lecanemab or placebo. The maximum dose used in the study is 10 milligrams per kilogram of body weight. Participants will need to have a study partner who spends at least 8 hours per week with them to help monitor their condition throughout the study. The total duration of treatment may last up to 48 months, including both the main phase and extension phase of the study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo several tests to confirm eligibility, including memory assessment and brain imaging

    Your brain amyloid levels will be checked either through a PET scan or spinal fluid test

    Basic health measurements will be taken, including body mass index (BMI)

  2. Step 2

    Treatment phase - first 18 months

    Lecanemab or placebo will be given through an intravenous infusion

    Regular assessments will track changes in memory and daily activities

    Brain scans will monitor amyloid levels

    Your ability to perform daily tasks will be evaluated using standard tests

  3. Step 3

    Extension phase

    After the initial 18-month period, the study continues with an open-label extension

    Regular safety monitoring including vital signs, ECG, and laboratory tests

    Continued assessment of memory and daily function

    Brain imaging to track changes

  4. Step 4

    Study partner involvement

    Your designated study partner must spend at least 8 hours per week with you

    The study partner will help provide information about your daily activities and changes in condition

    They must attend specific visits where quality of life and daily activities are assessed

  5. Step 5

    Monitoring and assessments

    Regular evaluation of memory and thinking abilities

    Testing of physical health status

    Assessment of ability to perform daily activities

    The study continues until approximately November 2026

Who can join the trial?

10 criteria

  • Age between 50 and 90 years old at the time of giving consent
  • Body Mass Index (BMI) must be between 17 and 35
  • Must have a memory decline that: - Started gradually - Has been present for at least 1 year - Can be confirmed by a family member or friend
  • Must score 22 or higher, but not more than 30 on the Mini-Mental State Examination (a test that measures thinking and memory abilities)
  • Must have a dedicated study partner who: - Spends at least 8 hours per week with the participant - Can attend study visits - Can provide information about the participant's condition - Is willing to sign a consent form
  • If currently taking Alzheimer's medications, must be on a stable dose for at least 12 weeks before starting the study
  • Must show evidence of brain amyloid (a protein associated with Alzheimer's) through either: - A brain scan (PET scan) - Or a spinal fluid test
  • Must show memory impairment on specific memory tests, scoring at least one standard deviation below the average for their age group
  • Must be able to provide informed consent (or have a legal representative who can provide consent if required by local laws)
  • Must be willing and able to follow all study procedures and requirements

Who cannot join the trial?

15 criteria

  • Age below 50 or above 90 years old
  • Any neurological disorder other than mild cognitive impairment or mild Alzheimer's disease that could affect mental function
  • History of brain bleeding or multiple small strokes
  • Current use of blood-thinning medications (except low-dose aspirin)
  • Presence of more than 4 microhemorrhages (tiny areas of bleeding in the brain) seen on brain scans
  • Significant psychiatric illness in the past 6 months
  • History of alcohol or substance abuse in the past 5 years
  • Severe liver or kidney disease
  • Unstable heart disease or recent heart attack (within past year)
  • Uncontrolled high blood pressure
  • Active cancer or cancer treatment within the past 5 years
  • Participation in other clinical trials within the past 30 days
  • Previous treatment with medications targeting amyloid (a protein associated with Alzheimer's disease)
  • Inability to undergo MRI (magnetic resonance imaging) scans
  • Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study
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Investigated drugs

BAN2401 is an investigational medication being studied for the treatment of early Alzheimer's disease. It is designed to target and remove harmful proteins in the brain that are believed to contribute to the progression of Alzheimer's disease. The medication aims to slow down cognitive decline and improve daily functioning in people with early-stage Alzheimer's disease.

What is already known about the treatment

BAN2401 - An investigational monoclonal antibody administered through intravenous infusion, currently being studied for the treatment of early Alzheimer's disease and mild cognitive impairment. The medication works by targeting and removing toxic beta-amyloid protein aggregates in the brain, which are believed to contribute to the progression of Alzheimer's disease. BAN2401 belongs to the class of disease-modifying therapies and is being evaluated in clinical trials to assess its ability to slow cognitive decline and improve daily functioning in patients with early-stage Alzheimer's disease, with safety and efficacy being measured through the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale over an 18-month treatment period.

Investigated diseases

  • Mild Cognitive Impairment due to Alzheimer's Disease

    A condition characterized by noticeable decline in memory and thinking skills that is greater than normal age-related changes but not severe enough to significantly impact daily activities. It represents an early stage of cognitive decline where a person experiences memory lapses, difficulty with complex tasks, and mild problems with judgment or reasoning. The condition primarily affects memory, particularly the ability to learn and recall new information. People with this condition maintain their independence in everyday activities but may take longer to complete tasks or make more mistakes than before.

  • Mild Alzheimer's Disease Dementia

    The early stage of Alzheimer's disease where cognitive decline becomes more pronounced than in mild cognitive impairment. During this stage, individuals experience increasing difficulty with memory, particularly in remembering recent events and learning new information. People may have trouble with planning, organization, and handling complex tasks that they previously managed well. They might experience mild language difficulties, such as finding the right words, and may become confused about time or place occasionally. Despite these challenges, individuals in this stage can still function somewhat independently with some assistance.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510887-22-00Protocol codeBAN2401-G000-301Estimated enrolment1 906 patientsSponsorEisai Limited

sourced from the EU Clinical Trials Register and site verification

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