DIAN-TU-003, Amyloid Removal Trial, Lecanemab for DIAD
Research type
Research Study
Full title
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
IRAS ID
1010029
Contact name
Stephanie Belyew
Contact email
Sponsor organisation
Washington University School Of Medicine
Clinicaltrials.gov Identifier
Research summary
This is an open label study to treat dominantly inherited Alzheimer’s disease (DIAD) mutation carriers, who participated in the DIAN-TU-001 gantenerumab OLE (open label extension) period, with lecanemab for a minimum of 5 years. Open label means that both the researchers and participants will know the treatment they are receiving. The study is using a common close design which means that all participants will stop receiving treatment five years after the last participant is enrolled. It is expected that the trial may take up to 7 years for all participants to receive at least 5 years of treatment.
As the DIAN-TU-001 gantenerumab OLE period has ended, and there are a substantial number of participants who are approaching the estimated age that Alzheimer’s disease (AD) symptoms develop, it is critical to continue to monitor and treat these individuals to identify whether robust amyloid reduction prior to symptom onset (the first appearance of the signs or symptoms) can provide significant delay in disease progression.
Amyloid is a protein that can build up in the body. In people with AD, amyloid deposits clump together to form plaques around brain cells that disrupt normal cell function.
The purpose of this study is to discover the effects of amyloid removal on age of onset and disease progression, to find out if amyloid plaque can be fully removed in DIAD and to establish the effects of amyloid removal on biomarkers (a measurable indicator) of disease progression.
Lecanemab is the study drug. A 10 mg/kg dose will be administered to the participants as an intravenous (IV – into the vein) infusion every 2 weeks. In-clinic and home visits will be conducted per the treatment schedule and to complete the protocol required procedures and safety MRI scans.
All participants will be co-enrolled in the DIAN Observational (DIAN Obs) natural history study (NCT00869817) through which clinical, cognitive, imaging (safety MRI) and biomarker assessments will be conducted.REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0196
Date of REC Opinion
6 Aug 2024
REC opinion
Further Information Favourable Opinion