Alzheimer's & dementia : the journal of the Alzheimer's Association
Phase 3 randomized trial of latozinemab in frontotemporal dementia due to GRN mutations
By Simmons A, Boeve B, Ber IL and 22 others.
Abstract
Introduction
Heterozygous progranulin gene mutations causing frontotemporal dementia (FTD-GRN) are associated with deficiency in progranulin (PGRN). Latozinemab is a human monoclonal immunoglobulin G1 (IgG1) antibody designed to elevate PGRN levels in people with heterozygous loss-of-function (LOF) GRN mutations.
Methods
A pivotal phase 3 trial, INFRONT-3 (NCT04374136), evaluated the efficacy, safety, and biomarker changes of 60 mg/kg of intravenously administered latozinemab or placebo every 4 weeks for 96 weeks in participants who have or are at risk for FTD due to heterozygous LOF GRN mutations. Those completing the double-blind phase could enter a 96-week open-label safety extension.