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

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).

Timeline

Start

2019-06-10

Primary completion

2022-04-19

Completion

2022-04-19

Outcome

Missed primary endpoint

registry analysis (superiority test); Crenezumab - Mutation Carriers vs Placebo - Mutation Carriers; p = 0.1953; Difference in Annualized Rate of Change -0.0130 (95% CI -0.0327 to 0.0068); RCRM NCT03977584 ↗

Drugs

Indications