AL001 for Frontotemporal Dementia
Trial Summary
What is the purpose of this trial?
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.
Research Team
Peter Ljubenkov, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for individuals in good physical health who have specific genetic mutations (GRN or C9orf72) linked to frontotemporal dementia. Women must not be pregnant or breastfeeding. Excluded are those living in long-term care facilities, with a history of substance abuse, or severe allergies to certain antibodies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous administration of AL001 every 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term to assess safety and tolerability
Treatment Details
Interventions
- AL001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alector Inc.
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School