Treatment for genetic Alzheimer's disease using lecanemab
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
This study is testing if lecanemab can help people with a genetic form of Alzheimer's disease by removing harmful plaque in the brain and slowing down the disease's progression.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | gantenerumab, lecanemab, immunotherapy |
| Locations | 6 sites (Birmingham, Alabama and 5 other locations) |
| Trial ID | NCT06384573 on ClinicalTrials.gov |
What this trial studies
This open-label trial aims to treat participants with dominantly inherited Alzheimer's disease (DIAD) who have previously participated in the gantenerumab Open Label Extension. The study will evaluate the effects of lecanemab on amyloid plaque removal and its impact on the age of onset and clinical progression of the disease. Participants will be monitored for changes in biomarkers of disease progression as they receive ongoing anti-amyloid therapy. The trial builds on previous findings from the DIAN-TU-001 gantenerumab study, which has provided valuable insights into the treatment of Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in the DIAN-TU-001 gantenerumab Open Label Extension and are willing to continue anti-amyloid therapy.
Not a fit: Patients who have not participated in the prior gantenerumab study or those with contraindications to amyloid-related imaging abnormalities may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could significantly delay the onset and progression of Alzheimer's disease in genetically predisposed individuals.
How similar studies have performed: Previous studies with similar approaches have shown promising results in the treatment of dominantly inherited Alzheimer's disease, indicating a potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 5 other locations
- University of Alabama in Birmingham — Birmingham, Alabama, United States (Recruiting)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
- Washington University in St. Louis — Saint Louis, Missouri, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
- Neuroscience Research Australia — Randwick, New South Wales, Australia (Recruiting)
- The National Hospital for Neurology and Neurosurgery — London, Greater London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Jamie Bartzel, MA
- Email: dianexr@wustl.edu
- Phone: 844-DIANEXR (342-6397)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.