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

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506873-36-00

Enrollment

Registered

2024-10-18

Start date

2020-06-29

Completion date

2026-01-06

Last updated

2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frontotemporal dementia (FTD)

Brief summary

Change from baseline to Weeks 48, 72, and 96 in the CDR® plus NACC FTLD-SB.

Detailed description

Change from baseline to Weeks 48, 72, and 96 on the CGI-S., Actual values at Weeks 48, 72, and 96 on the CGI-I., Change from baseline to Weeks 48, 72, and 96 on the RBANS.

Interventions

DRUGlatozinemab

DRUGPlacebo: sterile solution for intravenous infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to Weeks 48, 72, and 96 in the CDR® plus NACC FTLD-SB.	—

Secondary

Measure	Time frame
Change from baseline to Weeks 48, 72, and 96 on the CGI-S., Actual values at Weeks 48, 72, and 96 on the CGI-I., Change from baseline to Weeks 48, 72, and 96 on the RBANS.	—

Countries

Belgium, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026