DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease
NCT ID: NCT06384573
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
43 participants
INTERVENTIONAL
2024-06-10
2030-06-30
Brief Summary
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Detailed Description
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The DIAN-TU-001 gantenerumab OLE period has reached the end of participation and there is an urgent need to launch a trial that will allow for the continued amyloid removal treatment and monitoring of these uniquely informative individuals. The range of exposure duration in these individuals to gantenerumab is large: 2 to 10 years. Because there are a substantial number of participants that are approaching the estimated age that AD symptoms develop, it is critical to continue to monitor and treat these individuals to identify whether robust amyloid reduction prior to symptom onset can provide significant delay in disease progression.
In summary, the main reason for conducting this study is to gather key data to answer important outstanding scientific and clinical care questions for dominantly inherited AD and sporadic AD. These include improved insights into efficacy-related questions regarding drug dose and duration, mechanism of action, target population, and target disease stage that results in optimal benefit to patients. An evaluation of the long-term effects of amyloid removal on disease progression in DIAD could provide the first proof of concept that removing amyloid years before symptom onset could have major effects in delaying symptom onset by years, and to provide estimates for the relative effect sizes by years to symptom onset. Additionally, this study could provide the first evidence that patients can be treated with mechanistically different amyloid removing drugs to achieve full amyloid removal. Together these insights could offer guidance as to how clinicians can use lecanemab, a monoclonal antibody passive immunotherapy, in the era of multiple available amyloid removing treatments.
Participants in this trial will be co-enrolled in the DIAN Observational Study (DIAN Obs, NCT00869817). DIAN Obs represents a unique translational study in AD research that has provided transformational, data-driven models of the sequence of biomarkers abnormalities in preclinical DIAD. DIAN Obs is the largest longitudinal, multi-national study tracking DIAD families using a uniform protocol. To maximize the efficiency and utility of the DIAN Obs, the study introduced several efficiencies including 1) harmonizing protocols with the DIAN-TU, 2) applying International Conference on Harmonization Good Clinical Practice (ICH GCP) standards and a global unique identifier (GUID) at all performance sites to facilitate data sharing between all DIAN studies. Annual assessments will be performed for this population to collect clinical and cognitive data, amyloid and tau PET imaging, and cerebrospinal fluid (CSF) and plasma biomarkers for primary and secondary outcomes.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lecanemab
Starting at Week 0, participants will receive open-label lecanemab administered intravenously approximately every 2 weeks for a minimum of 5 years utilizing a common close design.
lecanemab
Administered intravenously
Interventions
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lecanemab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Alzheimer's Association
OTHER
Eisai Inc.
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Randall J Bateman, MD
Role: STUDY_DIRECTOR
Washington University School of Medicine
Locations
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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
Countries
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References
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Salloway S, Farlow M, McDade E, Clifford DB, Wang G, Llibre-Guerra JJ, Hitchcock JM, Mills SL, Santacruz AM, Aschenbrenner AJ, Hassenstab J, Benzinger TLS, Gordon BA, Fagan AM, Coalier KA, Cruchaga C, Goate AA, Perrin RJ, Xiong C, Li Y, Morris JC, Snider BJ, Mummery C, Surti GM, Hannequin D, Wallon D, Berman SB, Lah JJ, Jimenez-Velazquez IZ, Roberson ED, van Dyck CH, Honig LS, Sanchez-Valle R, Brooks WS, Gauthier S, Galasko DR, Masters CL, Brosch JR, Hsiung GR, Jayadev S, Formaglio M, Masellis M, Clarnette R, Pariente J, Dubois B, Pasquier F, Jack CR Jr, Koeppe R, Snyder PJ, Aisen PS, Thomas RG, Berry SM, Wendelberger BA, Andersen SW, Holdridge KC, Mintun MA, Yaari R, Sims JR, Baudler M, Delmar P, Doody RS, Fontoura P, Giacobino C, Kerchner GA, Bateman RJ; Dominantly Inherited Alzheimer Network-Trials Unit. A trial of gantenerumab or solanezumab in dominantly inherited Alzheimer's disease. Nat Med. 2021 Jul;27(7):1187-1196. doi: 10.1038/s41591-021-01369-8. Epub 2021 Jun 21.
Bateman RJ, Aisen PS, De Strooper B, Fox NC, Lemere CA, Ringman JM, Salloway S, Sperling RA, Windisch M, Xiong C. Autosomal-dominant Alzheimer's disease: a review and proposal for the prevention of Alzheimer's disease. Alzheimers Res Ther. 2011 Jan 6;3(1):1. doi: 10.1186/alzrt59.
Morris JC, Aisen PS, Bateman RJ, Benzinger TL, Cairns NJ, Fagan AM, Ghetti B, Goate AM, Holtzman DM, Klunk WE, McDade E, Marcus DS, Martins RN, Masters CL, Mayeux R, Oliver A, Quaid K, Ringman JM, Rossor MN, Salloway S, Schofield PR, Selsor NJ, Sperling RA, Weiner MW, Xiong C, Moulder KL, Buckles VD. Developing an international network for Alzheimer research: The Dominantly Inherited Alzheimer Network. Clin Investig (Lond). 2012 Oct 1;2(10):975-984. doi: 10.4155/cli.12.93.
Moulder KL, Snider BJ, Mills SL, Buckles VD, Santacruz AM, Bateman RJ, Morris JC. Dominantly Inherited Alzheimer Network: facilitating research and clinical trials. Alzheimers Res Ther. 2013 Oct 17;5(5):48. doi: 10.1186/alzrt213. eCollection 2013.
Mills SM, Mallmann J, Santacruz AM, Fuqua A, Carril M, Aisen PS, Althage MC, Belyew S, Benzinger TL, Brooks WS, Buckles VD, Cairns NJ, Clifford D, Danek A, Fagan AM, Farlow M, Fox N, Ghetti B, Goate AM, Heinrichs D, Hornbeck R, Jack C, Jucker M, Klunk WE, Marcus DS, Martins RN, Masters CM, Mayeux R, McDade E, Morris JC, Oliver A, Ringman JM, Rossor MN, Salloway S, Schofield PR, Snider J, Snyder P, Sperling RA, Stewart C, Thomas RG, Xiong C, Bateman RJ. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Rev Neurol (Paris). 2013 Oct;169(10):737-43. doi: 10.1016/j.neurol.2013.07.017. Epub 2013 Sep 6.
McDade E, Cummings JL, Dhadda S, Swanson CJ, Reyderman L, Kanekiyo M, Koyama A, Irizarry M, Kramer LD, Bateman RJ. Lecanemab in patients with early Alzheimer's disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alzheimers Res Ther. 2022 Dec 21;14(1):191. doi: 10.1186/s13195-022-01124-2.
van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.
Ryman DC, Acosta-Baena N, Aisen PS, Bird T, Danek A, Fox NC, Goate A, Frommelt P, Ghetti B, Langbaum JB, Lopera F, Martins R, Masters CL, Mayeux RP, McDade E, Moreno S, Reiman EM, Ringman JM, Salloway S, Schofield PR, Sperling R, Tariot PN, Xiong C, Morris JC, Bateman RJ; Dominantly Inherited Alzheimer Network. Symptom onset in autosomal dominant Alzheimer disease: a systematic review and meta-analysis. Neurology. 2014 Jul 15;83(3):253-60. doi: 10.1212/WNL.0000000000000596. Epub 2014 Jun 13.
Related Links
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Expanded registry
Other Identifiers
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The Alzheimer's Association
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DIAN-TU-003
Identifier Type: -
Identifier Source: org_study_id