drugset / Trial / NCT04374136

A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)

NCT04374136 ↗

Phase 3 Terminated 119 enrolled Alector Inc. GlaxoSmithKline · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.

Timeline

Start
2020-07-23
Primary completion
2025-09-01
Completion
2026-01-06

Outcome

Outcome not reported

Stopped: “The trial did not meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR® plus NACC FTLD-SB)”

Drugs

EvaluationDrugModalityDoseRoute
Subject Latozinemab Monoclonal antibody 60 mg/kg Intravenous