NCT03987295

A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)

A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Alector Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 open label study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL001 in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

Detailed description

This is a Phase 2, multicenter, open label study evaluating the safety, tolerability, PK and PD of AL001 administered intravenously in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

Conditions

• Frontotemporal Dementia

Interventions

Type	Name	Description
DRUG	AL001	60 mg/kg of AL001 every 4 weeks

Timeline

• Start date: 2019-09-27
• Primary completion: 2024-06-05
• Completion: 2024-06-05
• First posted: 2019-06-17
• Last updated: 2025-12-05
• Results posted: 2025-08-22

Locations

12 sites across 6 countries: United States, Canada, Germany, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study