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A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
Sponsor: Alector Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
25 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
119
Start Date
2020-07-23
Completion Date
2026-01-06
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Part 1 Blinded - AL001
Administered via intravenous (IV) infusion
Part 1 Blinded - Placebo
Administered via intravenous (IV) infusion
Part 2 (OLE Treatment) - AL001
Administered via intravenous (IV) infusion
Part 2 (OLE Treatment) - Placebo Switched to AL001
Administered via intravenous (IV) infusion
Locations (44)
Dignity Health
Phoenix, Arizona, United States
University of California San Diego
La Jolla, California, United States
University of Colorado
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States
University of Kansas Alzheimer's Disease Center
Fairway, Kansas, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Mayo Comprehensive Cancer Center - PPDS
Rochester, Minnesota, United States
Irving Institute for Clinical and Translational Research
New York, New York, United States
University Of Cincinnati Gardner Neuroscience institute
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Methodist Institute for Academic Medicine
Houston, Texas, United States
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia
Buenos Aires, Argentina
Box Hill Hospital
Box Hill, Australia
The Queen Elizabeth Hospital
Woodville, Australia
UZ Leuven
Leuven, Vlaams Brabant, Belgium
The University of Western Ontario
London, Canada
Sunnybrook Research Institute - University of Toronto
Toronto, Canada
CHU de Bordeaux
Bordeaux, France
CHRU Lille
Lille, France
Groupe Hospitalier Pitié Salpétrière
Paris, France
Uniklinik Köln
Cologne, Germany
Universitätsklinikum Ulm
Ulm, Germany
Eginitio University General Hospital of Athens - 1st University Neurology Clinic
Athens, Attica, Greece
University General Hospital of Alexandroupolis - Department of Neurology
Alexandroupoli, Evros, Greece
Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara
Baggiovara, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Italy
IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
Brescia, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
Milan, Italy
PIA Fondazione Panico
Tricase, Italy
Erasmus MC
Rotterdam, Netherlands
Centro Hospitalar do Porto - Hospital de Santo António
Porto, Porto District, Portugal
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, Portugal
Hospital CUF Descobertas
Lisbon, Portugal
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain
Karolinska Universitetssjukhuset Huddinge - PPDS
Huddinge, Sweden
Felix Platter Spital
Basel, Switzerland
Istanbul University Medical Faculty
Istanbul, Fatih, Turkey (Türkiye)
University College London
London, United Kingdom