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New drug combo aims to halt Alzheimer's in people with genetic mutation

NCT ID NCT05269394

Disease control Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study tests whether two drugs, E2814 and lecanemab, can slow the progression of Alzheimer's in people who carry a gene mutation that causes the disease. About 197 participants will receive either the drugs or a placebo over 2 to 4 years. Researchers will measure changes in tau protein buildup in the brain and track memory and thinking skills.

What this could mean

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

Active substance
E2814 and lecanemab (drugs given intravenously)
What this could lead to
If successful, this could lead to a treatment that slows or delays memory loss and dementia in people with inherited Alzheimer's disease.
What could go wrong
This is an early-to-mid-stage trial with only 197 participants, so results may not apply to everyone. The drugs may cause side effects like brain swelling or bleeding, and the treatment may not slow the disease enough to make a real difference.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

197 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 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: * Between 18-80 years of age * Individuals who know they have an Alzheimer's disease-causing mutation. * Are within -10 to + 10 years of the predicted or actual age of cognitive symptom onset. * Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive) * Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning * Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations. * For women of childbearing potential, if partner is not sterilized, participant must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide). * Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments. * Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion. Key Exclusion Criteria: * Significant neurologic disease (other than AD) or psychiatric disease that may currently or during the course of the study affect cognition or participant's ability to complete the study. * At high risk for suicide, e.g., significant suicidal ideation or attempt within last 12 months. Current stable mild depression or current use of antidepressant medications is not exclusionary. * History or presence of brain MRI scans indicative of any other significant abnormality * Substance or alcohol use disorder currently or within the past 1 year * Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan. * History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders * Anticoagulants except low dose (≤ 325 mg) aspirin. * Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months. * History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years. * Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial. * Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia familial Alzheimer disease

As listed by the trial registrant

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

Alzheimers disease Alzheimers disease, familial Dementia

Contacts and locations

Locations

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

  • Alzheimer's Research Australia

    Melbourne, Victoria, 3010, Australia

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134, Italy

  • Brain Research Center

    Amsterdam, 1081 GM, Netherlands

  • Butler Hospital

    Providence, Rhode Island, 02096, United States

  • CHU de Quebec - Hôpital de l' Enfant Jésus

    Québec, G1J 1Z4, Canada

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, Seine Maritime, 76031, France

  • CHU de Toulouse - Hôpital Purpan

    Toulouse, Haute Garonne, 31059, France

  • Emory University

    Atlanta, Georgia, 30329, United States

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, Paris, 69677, France

  • Grupo de Neurociencias Sede de la Universidad de Antioquia

    Medellín, Colombia

  • Hopital Neurologique Pierre Wertheimer

    Bron, Rhone, 69677, France

  • Hopital Roger Salengro - CHU Lille

    Lille, Nord, 59037, France

  • Hospital Clínic I Provincial de Barcelona

    Barcelona, 8036, Spain

  • Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, 05403-000, Brazil

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    Brescia, 25125, Italy

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

    Mexico City, Mexico City, 14269, Mexico

  • Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

    Ciudad Autonoma de Buenos Aire, C1428AQK, Argentina

  • Kerwin Research Center,

    Dallas, Texas, 75231, United States

  • LMU-Campus Grosshadern

    Munich, Bavaria, 81377, Germany

  • McGill Center for Studies in Aging

    Verdun, Quebec, H4H 1R3, Canada

  • Neuroscience Research Australia

    Randwick, New South Wales, 2031, Australia

  • St Vincent's University Hospital

    Dublin, DUBLIN 4, Ireland

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The National Hospital for Neurology and Neurosurgery

    London, Greater London, WC1B 3BG, United Kingdom

  • USC Keck School of Medicine

    Los Angeles, California, 90033, United States

  • Universitaetsklinikum Tubingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University of Alabama in Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California San Diego Medical Center

    La Jolla, California, 92037, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Puerto Rico, School of Medicine

    San Juan, 00936, Puerto Rico

  • University of Tokyo Hospital

    Bunkyō City, Tokyo-To, 113-8655, Japan

  • University of Washington

    Seattle, Washington, 98195, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06510, United States

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