A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
NCT ID: NCT04374136
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
110 participants
INTERVENTIONAL
2020-07-23
2027-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AL001
AL001 every 4 weeks
AL001
Administered via intravenous (IV) infusion
Placebo
Placebo every 4 weeks
Placebo
Administered via intravenous (IV) infusion
Open label - AL001
AL001 every 4 weeks
Open label - AL001
Administered via intravenous (IV) infusion
Interventions
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AL001
Administered via intravenous (IV) infusion
Placebo
Administered via intravenous (IV) infusion
Open label - AL001
Administered via intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* If symptomatic, one or more of the criteria for the diagnosis of possible behavioral variant FTD, or a diagnosis of Primary Progressive Aphasia.
* Study partner who consents to study participation and who cares for/visits the participant daily for at least 5 hours per week.
* Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
Exclusion Criteria
* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
* Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.
* Females who are pregnant or breastfeeding, or planning to conceive within the study period.
* Any experimental vaccine or gene therapy.
* History of cancer within the last 5 years.
* Current use of anticoagulant medications (e.g., coumadin, heparinoids, apixaban).
* Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
25 Years
85 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Alector Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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TBD TBD
Role: PRINCIPAL_INVESTIGATOR
Locations
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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
Countries
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Other Identifiers
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AL001-3
Identifier Type: -
Identifier Source: org_study_id
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