NCT04374136

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

A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Alector Inc. · Industry
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 administered intravenously in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene. Study completion marks the end of the open label extension period following the 96-week blinded portion of the study.

Conditions

• Frontotemporal Dementia

Interventions

Type	Name	Description
DRUG	AL001	Administered via intravenous (IV) infusion
DRUG	Placebo	Administered via intravenous (IV) infusion
DRUG	Open label - AL001	Administered via intravenous (IV) infusion

Timeline

• Start date: 2020-07-23
• Primary completion: 2025-09-01
• Completion: 2026-01-06
• First posted: 2020-05-05
• Last updated: 2026-01-21

Locations

44 sites across 16 countries: United States, Argentina, Australia, Belgium, Canada, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study