Continuation Study for Latozinemab

January 20, 2026 updated by: Alector Inc.

A Continuation Study of Latozinemab in Participants With Neurodegenerative Disease

Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is an open-label continuation study to provide access and assess the safety and tolerability of latozinemab in participants who have completed participation in their parent latozinemab study.

All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks (q4w).

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 0A7
        • Parkwood Institute
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • France
      • Paris, France, 75013
        • Groupe Hospitalier Pitié Salpêtrière
  • Germany
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm - Leimgrubenweg 12-14
  • Italy
      • Brescia, Italy, 25125
        • IRCCS - Centro S. Giovanni di Dio Fatebenefratelli
      • Milan, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Fracesco Sforza 35
      • Modena, Italy, 41126
        • Azienda Ospedaliero Universitaria Di Modena Policlinico
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC-Dr. Molewaterplein 40
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar E Universitario de Coimbra EPE
      • Lisbon, Portugal, 1649-028
        • Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital de Santa Maria
  • Sweden
      • Huddinge, Sweden, SE-14186
        • Karolinska Universitetssjukhuset Huddinge
  • United Kingdom
      • London, United Kingdom, WC1NAR
        • University College London
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Dignity Health - Arizona
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Comprehensive Cancer Center - PPDS
    • New York
      • New York, New York, United States, 10032
        • Irving Institute for Clinical and Translational Research
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Gardner Neuroscience Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
  • Has successfully completed participation in their parent latozinemab study.
  • Female participants must be nonpregnant and nonlactating.
  • Male participants must agree to acceptable contraception use.

Exclusion Criteria:

  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
  • Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label
Latozinemab (AL001) administered by IV infusion over 60 minutes, q4w
Drug: Latozinemab
All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks
Other Names:
  • AL001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants receiving latozinemab
Time Frame: Through study completion, up to 190 weeks
Number of participants receiving latozinemab
Through study completion, up to 190 weeks
Duration of treatment with latozinemab
Time Frame: Through study completion, up to 190 weeks
Duration of treatment with latozinemab
Through study completion, up to 190 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Through study completion, up to 190 weeks
Number and percentage of participants of AEs or SAEs
Through study completion, up to 190 weeks
Nature and severity of AEs and SAEs
Time Frame: Through study completion, up to 190 weeks
Severity of AEs and SAEs according to the World Health Organization (WHO) toxicity grading scale
Through study completion, up to 190 weeks
Incidence of ADAs to latozinemab
Time Frame: Through study completion, up to 190 weeks
Number and percentage of participants with anti-Drug Antibodies (ADA) titer over study time points
Through study completion, up to 190 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alector Inc.

Collaborators

GlaxoSmithKline

Investigators

  • Study Director: Study Lead, Alector Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2023

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

January 7, 2026

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL001-CS-302
  • 2023-506805-20-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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