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Study Details

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

This study will test an investigational drug called AL001 for the treatment of individuals who have a progranulin gene mutation that causes frontotemporal dementia (FTD). Participation may last up to 2 years.

You may be eligible to participate if you have a progranulin gene mutation and have been diagnosed with FTD (we call this group of people symptomatic participants). You may also be eligible to participate if you have a progranulin gene mutation but are not diagnosed with FTD and have an increased level of a biomarker called neurofilament light chain (NfL) [we call this group of people pre-symptomatic participants].

General Inclusion Criteria:

  • 18 to 85 years of age, inclusive, at screening
  • At screening, female participants must be nonpregnant and nonlactating
  • Has availability of a person (study partner) who has frequent and sufficient contact with the participant (at least 5 hours per week of in-person contact), can provide accurate information regarding the participant's behavior, cognitive, and functional abilities as well as their health throughout the study

Exclusion Criteria:

  • Has dementia due to a condition other than FTD including, but not limited to, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
Grant, Ian MichaelGrant, Ian Michael
NCT04374136 STU00212739
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