Overview

A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

Status:
Not yet recruiting

Trial end date:
2034-03-01

Target enrollment:

Participant gender:

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. Part 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. Part 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.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

Washington University School of Medicine

Collaborators:

Alzheimer's Association
Genentech, Inc.
Hoffmann-La Roche
National Institute on Aging (NIA)

Treatments:

Antibodies, Monoclonal