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

NCT04374136 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Frontotemporal Dementia

Interventions

DRUG

AL001

Administered via intravenous (IV) infusion

DRUG

Placebo

Administered via intravenous (IV) infusion

DRUG

Open label - AL001

Administered via intravenous (IV) infusion

Sponsors & Collaborators

Principal Investigators

  • TBD TBD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-23
Primary Completion
2025-09-01
Completion
2026-01-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04374136 on ClinicalTrials.gov