Overview

Tau Positron Emission Tomography (PET) Longitudinal Substudy Associated With: Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers in the Treatment of Autosomal-Dominant Alzheimer's Disease

Status:
Recruiting

Trial end date:
2022-03-31

Target enrollment:
0

Participant gender:
All

Summary

This substudy will evaluate the effect of crenezumab on the longitudinal tau burden in a subgroup of preclinical Presenilin1 (PSEN1) E280A mutation carriers and non-carriers, who were enrolled in study NCT01998841 (GN28352). Participants will receive up to three intravenous (IV) injections of [^18F] Genentech Tau Probe 1 (GTP1) and will undergo a tau positron emission tomography (PET) scan after each IV injection of [18^F]GTP1. The purpose of this substudy is to increase the understanding of disease progression in the preclinical stage of familial Alzheimer's Disease (AD).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Genentech, Inc.
Hoffmann-La Roche

Collaborators:

Banner Alzheimer's Institute
National Institute on Aging (NIA)

Criteria

Inclusion Criteria:

- Enrolled in main Study NCT01998841 (GN28352).

Exclusion Criteria:

- Contraindication to PET scan procedures, possibly including, but not limited to current,
past, or planned participation in studies involving radioactive agents, including the main
Study NCT01998841 (GN28352) and this Tau PET substudy, such that the total research-related
radiation dose to the participant in any given year would exceed the limits set forth in
the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.