Can a new drug stop inherited Alzheimer's in its tracks?
NCT ID NCT06384573
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This study tests lecanemab, an antibody that targets amyloid plaques in the brain, in 40 people who carry a gene mutation that causes early-onset Alzheimer's. Participants previously received another anti-amyloid drug and will now receive lecanemab to see if it can fully clear amyloid plaques and slow cognitive decline. The goal is to understand whether aggressive amyloid removal can delay or prevent the onset of dementia in this high-risk group.
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 called BAN2401), given as an intravenous infusion
- What this could lead to
- If successful, this could show that removing amyloid plaques delays or slows the progression of inherited Alzheimer's disease, offering a potential treatment for this rare form.
- What could go wrong
- This is a small, open-label study with no placebo group, so results may be less reliable. The drug may not fully remove plaques or meaningfully slow the disease, and side effects like brain swelling or bleeding are possible.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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40 people
The number who actually took part.
- Started
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Jun 2024
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Previously participated in the DIAN-TU-001 gantenerumab OLE period. * Willing to participate in ongoing anti-amyloid therapy with informed consent by participant or legally authorized representative. * People of childbearing potential (POCBP), if partner is not sterilized, must agree to use highly effective contraceptive measures (e.g., hormonal contraception, intra-uterine device, sexual abstinence, vasectomized partner) from Consent (V1) until five (5) halflives after last dose of any study drug. Refer to the study procedures manual for acceptable methods of contraception. * Co-enrollment in the DIAN Observational Study (DIAN Obs, NCT00869817) and is willing to complete DIAN Obs procedures and assessments. * Able to undergo safety MRI scans as required. * Vascular access adequate for study drug administration and safety monitoring. Key Exclusion Criteria: * Has any significantly increased risks associated with amyloid-related imaging abnormalities characterized by edema/effusion (ARIA-E), ARIA characterized by microhemorrhage (ARIA-H MCH) or superficial siderosis (ARIA-H SS) and vascular factors reviewed by the medical monitoring team. Risks to be reviewed include: 1. History of recurrent ARIA-E (2 or more episodes regardless of location). 2. More than 20 ARIA-H MCH. 3. More than one area of ARIA-H SS. 4. More than 2 lacunar infarcts or stroke involving a major vascular territory. * Requiring full anticoagulation or on high dose or dual antiplatelet therapy (daily aspirin 325 mg or less allowed). * History of macrohemorrhages \>1 cm. * Intolerance for lecanemab. * Pregnancy. * Breastfeeding. * Uncontrolled medical condition that is life threatening or precludes interpretation of AD. * Uncontrolled blood pressure including mean arterial pressure exceeding 97 mm Hg. * Uncontrolled seizure disorder. * Ongoing auto-immune condition, bleeding diathesis, or neutropenia (platelets lower than 50,000) major depression or psychiatric condition. * Exposure to other AD investigational agents within the past six months, or five half-lives from Visit 2 (Entry Visit) whichever is longer. * Active cancer/malignancy that could interfere with study evaluations.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
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Neuroscience Research Australia
Randwick, New South Wales, 2031, Australia
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The National Hospital for Neurology and Neurosurgery
London, Greater London, WC1B 3BG, United Kingdom
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University of Alabama in Birmingham
Birmingham, Alabama, 35294, United States
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University of Washington
Seattle, Washington, 98195, United States
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Washington University in St. Louis
St Louis, Missouri, 63110, United States
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