Active — Not RecruitingPhase 3

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

United States, Australia40 participantsStarted 2024-06-10

Plain-language 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

Age range18 Years

SexALL

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Exclusion criteria

✕. History of recurrent ARIA-E (2 or more episodes regardless of location).
✕. More than 20 ARIA-H MCH.
✕. More than one area of ARIA-H SS.
✕. More than 2 lacunar infarcts or stroke involving a major vascular territory.

What they're measuring

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

Timeframe: Week 0, Week 52, Week 104, Week 156, Week 208, Week 260, Week 312, Week 364

Trial details

NCT IDNCT06384573

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-06

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