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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopitaux Universitaires Pitie Salpetriere Paris France
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Fondazione Istituto G. Giglio Di Cafalu Cefalu' Italy
Hospital Victoria Eugenia De La Cruz Roja Espanola Sevilla Spain
Region Skane Skanes Universitetssjukhus Lund Sweden
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Central Institute of Mental Health Mannheim Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital Ruber Juan Bravo Madrid Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Neuro Centrum Science GmbH Erbach Germany
Psychiatry of TU Munich Munich Germany
Ahfgxxtixv Pnwfptyo Hcjrvsgs Dj Mggetusqo Marseille France
Unqradh Unpjvkbqxb Hcpyugha Uppsala Sweden
Hocgegnj De Lv Sgenb Cdcu I Srgd Pos Barcelona Spain
Utraergund Danjt Srraw Da Rdww Lg Sjwuxyah Rome Italy
Hkephzuv Ufovmkgwqcdhav Srjxtbydln &omajgc Hqgubcn du Hymkcdkcpyn STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.08.2019
Germany Germany
Not recruiting
01.08.2019
Italy Italy
Not recruiting
01.08.2019
Spain Spain
Not recruiting
01.08.2019
Sweden Sweden
Not recruiting
01.08.2019

Trial locations

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.

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 ID:
2024-510887-22-00
Protocol code:
BAN2401-G000-301
NCT ID:
NCT03887455
Trial Phase:
Therapeutic confirmatory (Phase III)

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