The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Amyloid Removal Trial (ART): A Phase IIIb/IV Open-Label Study of Lecanemab to Evaluate Prevention and Progression of Dominantly Inherited Alzheimer's Disease
Trial tests lecanemab to slow Alzheimer's in rare inherited form
Plain English Summary
DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease is a Phase 3 clinical trial sponsored by Washington University School of Medicine studying Alzheimer's Disease, Dementia, Alzheimer's Disease, Familial. This study tests the drug lecanemab to see if it can prevent or slow down Alzheimer's disease in people who have a specific gene that causes them to develop the disease early. It is for individuals who have a confirmed genetic mutation for dominantly inherited Alzheimer's disease (DIAD) and have previously participated in a related study. Participants will receive lecanemab intravenously and undergo regular assessments, including brain scans and cognitive tests. There are no direct alternatives for preventing or slowing this specific inherited form of Alzheimer's, but other Alzheimer's treatments exist for the more common forms of the disease. The trial aims to enroll 40 participants.
Official Summary
This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have a gene mutation that causes early-onset Alzheimer's and have been part of the DIAN-TU-001 study. You cannot join if you have certain risks for brain swelling or bleeding related to amyloid, have had multiple brain bleeds, or are taking strong blood thinners. Age is not a primary factor, but you must be able to undergo MRI scans and have adequate vein access for infusions. You must agree to use effective birth control if you can become pregnant and are not sterilized, and be willing to participate in a related observational study. This trial is studying Alzheimer's Disease, Dementia, Alzheimer's Disease, Familial, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how long it takes for symptoms of dementia to worsen, indicating how well lecanemab might preserve cognitive function and daily living abilities. The specific primary outcome measures are: The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB). (Week 0, Week 52, Week 104, Week 156, Week 208, Week 260, Week 312, Week 364). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial is important because it investigates a potential treatment to prevent or delay the onset of a rare, aggressive form of Alzheimer's disease caused by inherited genes, addressing a significan As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Alzheimer's Disease, Dementia, Alzheimer's Disease, Familial, where improved treatment options are needed.
Investor Insight
This trial targets a specific, rare genetic form of Alzheimer's, potentially paving the way for future treatments in this niche but devastating area, with lecanemab already approved for broader Alzhei Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of lecanemab, especially regarding brain swelling or bleeding. Understand that participation involves regular intravenous infusions of lecanemab and frequent medical check-ups, including MRI scans. Be prepared for the time commitment required for study visits and assessments over several years. The trial is being conducted at 6 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 40 participants
Interventions
- DRUG: lecanemab — Administered intravenously
Primary Outcomes
- The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB). (Week 0, Week 52, Week 104, Week 156, Week 208, Week 260, Week 312, Week 364)
Full Eligibility Criteria
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.
Trial Locations
- University of Alabama in Birmingham, Birmingham, Alabama, United States
- Indiana University School of Medicine, Indianapolis, Indiana, United States
- Washington University in St. Louis, St Louis, Missouri, United States
- University of Washington, Seattle, Washington, United States
- Neuroscience Research Australia, Randwick, New South Wales, Australia
- The National Hospital for Neurology and Neurosurgery, London, Greater London, United Kingdom
Frequently Asked Questions
What is clinical trial NCT06384573?
NCT06384573 is a Phase 3 INTERVENTIONAL study titled "DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease." It is currently active, not recruiting and is sponsored by Washington University School of Medicine. The trial targets enrollment of 40 participants.
What conditions does NCT06384573 study?
This trial investigates treatments for Alzheimer's Disease, Dementia, Alzheimer's Disease, Familial. The primary condition under study is Alzheimer's Disease.
What treatments are being tested in NCT06384573?
The interventions being studied include: lecanemab (DRUG). Administered intravenously
What does Phase 3 mean for NCT06384573?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06384573?
This trial is currently "Active, Not Recruiting." It started on 2024-06-10. The estimated completion date is 2030-06.
Who is sponsoring NCT06384573?
NCT06384573 is sponsored by Washington University School of Medicine. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06384573?
The trial aims to enroll 40 participants. The trial status is active, not recruiting.
How is NCT06384573 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06384573?
The primary outcome measures are: The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB). (Week 0, Week 52, Week 104, Week 156, Week 208, Week 260, Week 312, Week 364). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06384573 being conducted?
This trial is being conducted at 6 sites, including Birmingham, Alabama; Indianapolis, Indiana; St Louis, Missouri; Seattle, Washington and 2 more sites (United States, Australia, United Kingdom).
Where can I find official information about NCT06384573?
The official record for NCT06384573 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06384573. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06384573 testing in simple terms?
This study tests the drug lecanemab to see if it can prevent or slow down Alzheimer's disease in people who have a specific gene that causes them to develop the disease early. It is for individuals who have a confirmed genetic mutation for dominantly inherited Alzheimer's disease (DIAD) and have previously participated in a related study.
Why is this trial significant?
This trial is important because it investigates a potential treatment to prevent or delay the onset of a rare, aggressive form of Alzheimer's disease caused by inherited genes, addressing a significan As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06384573?
The main risks include amyloid-related imaging abnormalities (ARIA), which can cause brain swelling (ARIA-E) or bleeding (ARIA-H). Other potential side effects may include infusion-related reactions, headache, and dizziness. Close monitoring with MRI scans is crucial to detect and manage any signs of ARIA. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06384573?
Ask your doctor about the potential benefits and risks of lecanemab, especially regarding brain swelling or bleeding. Understand that participation involves regular intravenous infusions of lecanemab and frequent medical check-ups, including MRI scans. Be prepared for the time commitment required for study visits and assessments over several years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06384573 signal from an investment perspective?
This trial targets a specific, rare genetic form of Alzheimer's, potentially paving the way for future treatments in this niche but devastating area, with lecanemab already approved for broader Alzhei This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive lecanemab intravenously and undergo regular assessments, including brain scans and cognitive tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.