drugset / Trial / NCT04374136
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Latozinemab | Monoclonal antibody | 60 mg/kg | Intravenous |