DIAN-TU

Active not recruitingPhase 3

DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease

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

Lead sponsor

Washington University School of Medicine

Asset

Lecanemab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age ≥18•Brain MRI excludes superficial siderosis

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDDIAN-TU-003

NCT IDNCT06384573

Timeline

Milestones

Study first posted2024-04-25actual

Study start2024-06-10actual

Last update posted2026-03-05actual

Primary completion2030-06estimated (month precision)

Study completion2030-06estimated (month precision)

Assets

Drug assets

Lecanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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

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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

1 endpoint

Primary/protocol endpoint

The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB).

Time frame:Week 0, Week 52, Week 104, Week 156, Week 208, Week 260, Week 312, Week 364

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

time to event, event

Publications (8)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.