A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)

Last updated: January 22, 2025
Sponsor: Alector Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dementia

Frontotemporal Dementia

Memory Loss

Treatment

Placebo

AL001

Open label - AL001

Clinical Study ID

NCT04374136
AL001-3
  • Ages 25-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Persons with a progranulin gene mutation and at risk of developing FTD symptoms asevidenced by a biomarker, or persons with a progranulin gene mutation and diagnosedwith FTD.

  • If symptomatic, one or more of the criteria for the diagnosis of possible behavioralvariant FTD, or a diagnosis of Primary Progressive Aphasia.

  • Study partner who consents to study participation and who cares for/visits theparticipant 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

Exclusion Criteria:

  • Dementia due to a condition other than FTD including, but not limited to,Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, Huntingtondisease, or vascular dementia.

  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactionsto chimeric, human, or humanized antibodies or fusion proteins.

  • Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinicallysignificant heart disease, liver disease or kidney disease. History or evidence ofclinically significant brain disease other than FTD.

  • Females who are pregnant or breastfeeding, or planning to conceive within the studyperiod.

  • 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 carefacility at screening; or requires continuous nursing care.

Study Design

Total Participants: 110
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 23, 2020
Estimated Completion Date:
August 03, 2027

Study Description

This is a phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 administered intravenously in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene. Study completion marks the end of the open label extension period following the 96-week blinded portion of the study.

Connect with a study center

  • CENydET S.R.L.

    Retiro, Ciudad Autónoma De BuenosAires C1058AAJ
    Argentina

    Site Not Available

  • Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia

    Buenos Aires, 2325
    Argentina

    Site Not Available

  • INECO Castaño

    San Juan, C1015ABR
    Argentina

    Site Not Available

  • Box Hill Hospital

    Box Hill, 3128
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, 2050
    Australia

    Site Not Available

  • Perron Institute for Neurological and Translational Science

    Subiaco,
    Australia

    Site Not Available

  • The Queen Elizabeth Hospital

    Woodville,
    Australia

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • The University of Western Ontario

    London,
    Canada

    Site Not Available

  • Sunnybrook Research Institute - University of Toronto

    Toronto,
    Canada

    Site Not Available

  • CHU de Toulouse Hopital PURPAN

    Toulouse, Haute-Garonne 31059
    France

    Site Not Available

  • Centre d'Investigation Clinique de Toulouse

    Toulouse, Haute-Garonne 31059
    France

    Site Not Available

  • Hopital Charles Nicolle - Hospital

    Rouen, Seinne-Maritime 76000
    France

    Site Not Available

  • CHU de Bordeaux

    Bordeaux,
    France

    Site Not Available

  • CHRU Lille

    Lille,
    France

    Site Not Available

  • Groupe Hospitalier Pitié Salpétrière

    Paris,
    France

    Site Not Available

  • Uniklinik Köln

    Köln, 50937
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig,
    Germany

    Site Not Available

  • Klinikum rechts der Isar der Technischen Universität München

    München,
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen,
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm,
    Germany

    Site Not Available

  • Eginitio University General Hospital of Athens - 1st University Neurology Clinic

    Athens, Attica 115 28
    Greece

    Site Not Available

  • University General Hospital of Alexandroupolis - Department of Neurology

    Alexandroupoli, Evros 68100
    Greece

    Site Not Available

  • Azienda Unita Sanita Locale (ASL) di Reggio Emilia - IRCCS

    Reggio Emilia, Emilia Romagna 42122
    Italy

    Site Not Available

  • Fondazione Istituto G.Giglio

    Cefalù, Palermo 90015
    Italy

    Site Not Available

  • Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara

    Baggiovara,
    Italy

    Site Not Available

  • Università degli studi Aldo Moro

    Bari,
    Italy

    Site Not Available

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    Bologna, 40139
    Italy

    Site Not Available

  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

    Brescia,
    Italy

    Site Not Available

  • IRCCS - Centro S. Giovanni di Dio Fatebenefratelli

    Brescia,
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano,
    Italy

    Site Not Available

  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

    Milano,
    Italy

    Site Not Available

  • Azienda Ospedale Universita Padova

    Padova, 35128
    Italy

    Site Not Available

  • PIA Fondazione Panico

    Tricase,
    Italy

    Site Not Available

  • Erasmus MC

    Rotterdam,
    Netherlands

    Site Not Available

  • Centro Hospitalar E Universitário de Coimbra EPE

    Coimbra,
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Hospital CUF Descobertas

    Lisboa,
    Portugal

    Site Not Available

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001
    Portugal

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia-san Sebastián,
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Karolinska Universitetssjukhuset Huddinge - PPDS

    Huddinge,
    Sweden

    Site Not Available

  • Felix Platter Spital

    Basel,
    Switzerland

    Site Not Available

  • Dokuz Eylul University

    Izmir, Balcova 35330
    Turkey

    Site Not Available

  • Istanbul University Medical Faculty

    Istanbul, Fatih 34093
    Turkey

    Site Not Available

  • University College London

    London,
    United Kingdom

    Site Not Available

  • Dignity Health

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093-0648
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Miami Medical Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Northwestern University

    Evanston, Illinois 60611
    United States

    Site Not Available

  • Indiana University Health Neuroscience Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas Alzheimer's Disease Center

    Fairway, Kansas 66205
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Mayo Comprehensive Cancer Center - PPDS

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Irving Institute for Clinical and Translational Research

    New York, New York 10032
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599-7025
    United States

    Site Not Available

  • University Of Cincinnati Gardner Neuroscience institute

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Case Western Reserve University

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Houston Methodist Institute for Academic Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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