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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Washington University School of Medicine
Study ID
NCT06384573
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 10, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Alabama in BirminghamBirminghamAlabama35294-
Indiana University School of MedicineIndianapolisIndiana46202-
Washington University in St. LouisSt LouisMissouri63110-
University of WashingtonSeattleWashington98195-

Find similar trials in Birmingham, AL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Alabama in Birmingham· Birmingham, ALIndiana University School of Medicine· Indianapolis, INWashington University in St. Louis· St Louis, MOUniversity of Washington· Seattle, WA

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