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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506805-20-00 | Other Identifier | EU Trial Number |
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The AL001-CS-302 study was terminated because its Phase 3 placebo-controlled parent study (AL001-3) failed to meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating® plus National Alzheimer's
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Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | Latozinemab (AL001) administered by IV infusion over 60 minutes, q4w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latozinemab | Drug | All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants receiving latozinemab | Number of participants receiving latozinemab | Through study completion, up to 190 weeks |
| Duration of treatment with latozinemab | Duration of treatment with latozinemab | Through study completion, up to 190 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incident of adverse events (AEs) and serious adverse events (SAEs) | Number and percentage of participants of AEs or SAEs | Through study completion, up to 190 weeks |
| Nature and severity of AEs and SAEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Lead | Alector Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health - Arizona | Phoenix | Arizona | 85013 | United States | ||
| Mayo Comprehensive Cancer Center - PPDS |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2026 | Jun 26, 2026 | 6 | ||
| Jul 9, 2026 |
| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D057180 | Frontotemporal Dementia |
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
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Open-label
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This is an open label continuation study
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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 | Number and percentage of participants with anti-Drug Antibodies (ADA) titer over study time points | Through study completion, up to 190 weeks |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Irving Institute for Clinical and Translational Research | New York | New York | 10032 | United States |
| University of Cincinnati Gardner Neuroscience Institute | Cincinnati | Ohio | 45219 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| UZ Leuven | Leuven | 3000 | Belgium |
| Parkwood Institute | London | Ontario | N6C 0A7 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Groupe Hospitalier Pitié Salpétrière | Paris | 75013 | France |
| Universitätsklinikum Ulm - Leimgrubenweg 12-14 | Ulm | 89075 | Germany |
| IRCCS - Centro S. Giovanni di Dio Fatebenefratelli | Brescia | 25125 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Fracesco Sforza 35 | Milan | 20122 | Italy |
| Azienda Ospedaliero Universitaria Di Modena Policlinico | Modena | 41126 | Italy |
| Erasmus MC-Dr. Molewaterplein 40 | Rotterdam | 3015 GD | Netherlands |
| Centro Hospitalar E Universitario de Coimbra EPE | Coimbra | 3000-075 | Portugal |
| Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital de Santa Maria | Lisbon | 1649-028 | Portugal |
| Karolinska Universitetssjukhuset Huddinge | Huddinge | SE-14186 | Sweden |
| University College London | London | WC1NAR | United Kingdom |
| D002493 |
| Central Nervous System Diseases |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D009468 | Neuromuscular Diseases |