A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)

 Behavioral Variant of Frontotemporal Dementia / Posted 3 weeks ago

A Phase 2 open label study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL001 in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.

  • Inclusion Criteria : Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No
    • At screening, female participants must be nonpregnant and nonlactating
    • In good physical health on the basis of no clinically significant findings from medical history, physical examinations (PEs), laboratory tests, ECGs, and vital signs.
    • Participant is a carrier of a loss of function progranulin gene (GRN) mutation or carrier of a hexanucleotide repeat expansion C9orf72 mutation
  • Exclusion Criteria :
    • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
    • History of alcohol abuse or substance abuse
    • Participant resides in a skilled nursing facility, convalescent home, or long term care facility
  • Study end date : 30/05/2023
  • Principal Investigator : Peter Ljubenkov, MD University of California

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