DIAN-TU-002, Remternetug for DIAD
Research type
Research Study
Full title
A Phase II/III Multicenter Randomized, Double-Blind, Placebo Controlled, Two-Stage Adaptive Design, Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer’s Disease.
IRAS ID
1010814
Contact name
Stephanie Belyew
Contact email
Sponsor organisation
Washington University School Of Medicine
Eudract number
2024-517187-36
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test a drug known as remternetug to determine its effectiveness for the treatment of asymptomatic (at risk) Alzheimer disease (AD) in individuals with AD-causing mutations. This study will also investigate the effects of remternetug on measures of the disease (called biomarkers) including brain scans, blood and spinal fluid tests, examine safety data to identify any potential benefits or risks, and examine how well participants can tolerate remternetug. During the study, participants will also have tests of memory and thinking.
Remternetug is a monoclonal antibody; monoclonal antibodies are proteins produced in a laboratory (instead of by the immune system) that are designed to recognise a specific substance in the body. Remternetug is designed to attach to and help the removal of a specific protein in the brain (called Amyloid beta) that is thought to contribute to a brain disorder in AD.
This study will consist of 2 stages; Stage 1 is the blinded study treatment period where remternetug will be compared against placebo (looks the same as remternetug and is given in the same way but has no active study drug in it) and Stage 2 is the open-label study treatment period all eligible participants will receive active study treatment with remternetug. Participants will be in Stage 1 for a minimum of 2 years, up to approximately 5 years until the last enrolled participant completes 2 years of treatment. Stage 2 will continue for up to an additional 4 years.REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0008
Date of REC Opinion
8 Apr 2025
REC opinion
Further Information Favourable Opinion