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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

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Trial Profile

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: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Feb 2024

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At a glance

  • Drugs Latozinemab (Primary)
  • Indications Frontotemporal dementia
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms INFRONT-2
  • Sponsors Alector

    • Most Recent Events

    • 07 Feb 2024 According to an Alector media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to latozinemab for the potential treatment of frontotemporal dementia with a progranulin gene mutation (FTD-GRN) based upon data from the INFRONT-2 Phase 2 clinical trial.
    • 28 Jun 2022 Planned End Date changed from 30 Mar 2023 to 2 Jun 2026.
    • 28 Jun 2022 Planned primary completion date changed from 30 Mar 2023 to 28 Jan 2026.
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