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
Washington University School of Medicine
Summary
The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Stage 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.
Description
This study will recruit participants from the Dominantly Inherited Alzheimer Network observational study (DIAN-OBS), a multicenter international study supported by the National Institutes of Health (Grant Number U01-AG032438; RJ Bateman), Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) sites, DIAN-TU partner sites, DIAN Expanded Registry (DIAN-EXR), and families identified by the sites. As part of the DIAN-TU-002 protocol, participants undergo longitudinal assessments that include clinical assessment, cognitive testing, magnetic resonance imaging (MRI) and amyloid imaging, and ana…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Provide written informed consent, signed, and dated by the participant and study partner, or by the participant's legally authorized representative if applicable, according to local regulations for the ICF and, if applicable, country specific ICFs. 2. Participant is at least 18 years old. 3. People of childbearing potential 1. Must have a negative serum pregnancy test at screening (V1) 2. Must agree not to try to become pregnant during the study until 5 half-lives after the last dose of any study drug. 3. Must agree not to breastfeed from the time of signed IC…
Interventions
- DrugRemternetug (SC)
Administered subcutaneously every 12 weeks
- DrugMatching Placebo (Remternetug)
Administered as subcutaneous injection of placebo every 12 weeks
Locations (35)
- University of Alabama in BirminghamBirmingham, Alabama
- University of California San Diego Medical CenterLa Jolla, California
- Yale University School of MedicineNew Haven, Connecticut
- Emory UniversityAtlanta, Georgia
- Advocate Lutheran General HospitalPark Ridge, Illinois
- Indiana University School of MedicineIndianapolis, Indiana