Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT03987295
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2019-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D057180', 'term': 'Frontotemporal Dementia'}], 'ancestors': [{'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alector.com', 'phone': '650-826-2454', 'title': 'Alector Medical Information', 'organization': 'Alector'}, 'certainAgreement': {'otherDetails': "Alector's agreements with principal investigators may vary but will not prohibit any investigator from publishing. Alector supports the publication of the results from all centers in a multi-center trial, and its agreements include provisions to enable the multi-center publication to occur before publication of data from a single site.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study had the following limitations:\n\n* No placebo control arm\n* Small number of participants\n* A high number of participants discontinued the study due to disease progression'}}, 'adverseEventsModule': {'timeFrame': '197 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 13, 'seriousNumAtRisk': 16, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Haemangioma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Seborrhoeic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diastolic hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Subclavian artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Administration site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Infusion site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hallucination, auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Illusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Impulsive behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Obsessive-compulsive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Device physical property issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Post lumbar puncture syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Procedural pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Life Threatening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '197 weeks', 'description': 'Number of treatment-related TEAEs categorized by severity', 'unitOfMeasure': 'TEAEs (treatment-related)', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this primary end point.'}, {'type': 'PRIMARY', 'title': 'Any TEAE Leading to Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '197 weeks', 'description': 'Number of TEAEs leading to study drug discontinuation', 'unitOfMeasure': 'TEAE leading to discontinuation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this primary end point.'}, {'type': 'PRIMARY', 'title': 'Immunogenicity Antidrug Antibodies (ADA) Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'title': 'Week 2 - ADA Titer', 'categories': [{'measurements': [{'value': '320.0', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '5120'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '2560'}, {'value': '40.0', 'spread': '0.00', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '160'}]}]}, {'title': 'Week 13 - ADA Titer', 'categories': [{'measurements': [{'value': '160.0', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '2560'}, {'value': '160.0', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '640'}, {'value': '120.0', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '160'}]}]}, {'title': 'Week 25 - ADA Titer', 'categories': [{'measurements': [{'value': '320.0', 'groupId': 'OG000', 'lowerLimit': '320', 'upperLimit': '320'}, {'value': '330.0', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '640'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '160'}]}]}, {'title': 'Week 37 - ADA Titer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '320'}, {'value': '90.0', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '160'}]}]}, {'title': 'Week 49 - ADA Titer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '320.0', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '640'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '20'}]}]}, {'title': 'Week 61 - ADA Titer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '160.0', 'groupId': 'OG002', 'lowerLimit': '160', 'upperLimit': '160'}]}]}, {'title': 'Week 73 - ADA Titer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '160.0', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '160'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Week 85 - ADA Titer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '160.0', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '160'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '20'}]}]}, {'title': 'Week 97 - ADA Titer', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '20'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '160.0', 'groupId': 'OG002', 'lowerLimit': '160', 'upperLimit': '160'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '97 weeks', 'description': 'Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study', 'unitOfMeasure': 'Titers', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this primary end point.'}, {'type': 'PRIMARY', 'title': 'Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'title': 'ADA Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'ADA Negative', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '97 weeks', 'description': 'Presence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Sheehan Suicidality Tracking Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '197 weeks', 'description': 'The Sheehan Suicidality Tracking Scale (S-STS) is a structured assessment tool used to evaluate the presence, severity, and frequency of suicidal ideation and behavior. It includes items that address passive thoughts of death, active suicidal ideation, intent, planning, suicide attempts, and non-suicidal self-injury. The S-STS total score ranges from 0 to 64, based on 16 items each rated from 0 (not at all) to 4 (extremely), with higher scores indicating greater severity of suicidal ideation, intent, or behavior. The total score provides a quantitative measure of suicidality severity and is sensitive to change over time, making it suitable for clinical monitoring and research use.', 'unitOfMeasure': 'Scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Longitudinal Percent Change From Baseline of CSF PGRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '198.16', 'spread': '110.255', 'groupId': 'OG000'}, {'value': '104.05', 'spread': '103.349', 'groupId': 'OG001'}, {'value': '101.61', 'spread': '38.492', 'groupId': 'OG002'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '189.46', 'spread': '113.802', 'groupId': 'OG000'}, {'value': '59.73', 'spread': '24.034', 'groupId': 'OG001'}, {'value': '144.73', 'spread': '54.994', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '97 weeks', 'description': 'The percent change from baseline to specified timepoints of PGRN in CSF. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.', 'unitOfMeasure': 'percent change of ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this secondary end point.'}, {'type': 'SECONDARY', 'title': 'Longitudinal Percent Change From Baseline in Plasma PGRN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '177.39', 'spread': '51.352', 'groupId': 'OG000'}, {'value': '151.32', 'spread': '59.321', 'groupId': 'OG001'}, {'value': '178.82', 'spread': '58.406', 'groupId': 'OG002'}]}]}, {'title': 'Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '185.37', 'spread': '43.763', 'groupId': 'OG000'}, {'value': '188.12', 'spread': '47.847', 'groupId': 'OG001'}, {'value': '157.93', 'spread': '92.695', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '97 weeks', 'description': 'The percent change from baseline to specified timepoints for PGRN in plasma. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.', 'unitOfMeasure': 'percent change in ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this secondary end point.'}, {'type': 'SECONDARY', 'title': 'Longitudinal Levels of Sortilin in WBCs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'timeFrame': '97 weeks', 'description': 'The overall change from baseline in Sortilin in WBCs.', 'reportingStatus': 'POSTED', 'populationDescription': 'WBC samples for analysis for Sortilin expression were collected to serve as a pharmacodynamic biomarker of target engagement. Development of this assay found that stability of these samples was not reliable for accurate measurement. Hence, we did not measure Sortilin in this study.'}, {'type': 'SECONDARY', 'title': 'Latozinemab Concentration in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'categories': [{'measurements': [{'value': '236000', 'spread': '69100', 'groupId': 'OG000'}, {'value': '250000', 'spread': '24700', 'groupId': 'OG001'}, {'value': '265000', 'spread': '77000', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '97 weeks', 'description': 'Serum concentration of Latozinemab at week 97.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this secondary end point.'}, {'type': 'SECONDARY', 'title': 'Cmax of Latozinemab at Specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'categories': [{'measurements': [{'value': '1810', 'spread': '352', 'groupId': 'OG000'}, {'value': '1320', 'spread': '255', 'groupId': 'OG001'}, {'value': '1510', 'spread': '145', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '97 weeks', 'description': 'Maximum observed concentration of Latozinemab at week 96 of treatment.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this secondary end point.'}, {'type': 'SECONDARY', 'title': 'Ctrough of Latozinemab at Specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'categories': [{'measurements': [{'value': '236', 'spread': '69.1', 'groupId': 'OG000'}, {'value': '250', 'spread': '24.7', 'groupId': 'OG001'}, {'value': '252', 'spread': '66.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '97 weeks', 'description': 'Trough concentration of Latozinemab at week 96 of treatment', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this secondary endpoint.'}, {'type': 'SECONDARY', 'title': 'ARCmax of Latozinemab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'OG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.236', 'groupId': 'OG001'}, {'value': '1.39', 'spread': '0.712', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '61 weeks', 'description': 'Ratio of latozinemab Cmax at week 61 to the Cmax at week 1', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There is no statistical analysis for this endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'FG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'FG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'aFTD-GRN', 'description': 'aFTD-GRN - asymptomatic frontotemporal dementia with heterozygous progranulin gene mutation\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'BG001', 'title': 'FTD-GRN', 'description': 'FTD-GRN - symptomatic carriers of GRN mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'BG002', 'title': 'FTD-C9orf72', 'description': 'FTD-C9orf72 - symptomatic carriers of C9orf72 hexanucleotide repeat expansion mutation causative of FTD\n\nPart 1 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period); Part 2 - Latozinemab administered intravenously (60 mg/kg, every 4 weeks \\[q4w\\]), for a total of 25 doses (96-week dosing period).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.0', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '63'}, {'value': '59.5', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '78'}, {'value': '60.0', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '74'}, {'value': '59.0', 'groupId': 'BG003', 'lowerLimit': '32', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-04', 'size': 3037709, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-05T15:14', 'hasProtocol': True}, {'date': '2024-03-19', 'size': 1941843, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-05T15:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2019-05-14', 'resultsFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-06', 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of TEAEs', 'timeFrame': '197 weeks', 'description': 'Number of TEAEs categorized by severity'}, {'measure': 'Severity of Treatment-Related TEAEs', 'timeFrame': '197 weeks', 'description': 'Number of treatment-related TEAEs categorized by severity'}, {'measure': 'Any TEAE Leading to Study Drug Discontinuation', 'timeFrame': '197 weeks', 'description': 'Number of TEAEs leading to study drug discontinuation'}, {'measure': 'Immunogenicity Antidrug Antibodies (ADA) Titer', 'timeFrame': '97 weeks', 'description': 'Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study'}, {'measure': 'Confirmatory Immunogenicity Antidrug Antibodies (ADA) Responses', 'timeFrame': '97 weeks', 'description': 'Presence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study).'}, {'measure': 'Change From Baseline in Sheehan Suicidality Tracking Scale', 'timeFrame': '197 weeks', 'description': 'The Sheehan Suicidality Tracking Scale (S-STS) is a structured assessment tool used to evaluate the presence, severity, and frequency of suicidal ideation and behavior. It includes items that address passive thoughts of death, active suicidal ideation, intent, planning, suicide attempts, and non-suicidal self-injury. The S-STS total score ranges from 0 to 64, based on 16 items each rated from 0 (not at all) to 4 (extremely), with higher scores indicating greater severity of suicidal ideation, intent, or behavior. The total score provides a quantitative measure of suicidality severity and is sensitive to change over time, making it suitable for clinical monitoring and research use.'}], 'secondaryOutcomes': [{'measure': 'Longitudinal Percent Change From Baseline of CSF PGRN', 'timeFrame': '97 weeks', 'description': 'The percent change from baseline to specified timepoints of PGRN in CSF. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.'}, {'measure': 'Longitudinal Percent Change From Baseline in Plasma PGRN', 'timeFrame': '97 weeks', 'description': 'The percent change from baseline to specified timepoints for PGRN in plasma. The baseline visit is labeled as week 1 and therefore the 96th week is labeled as week 97.'}, {'measure': 'Longitudinal Levels of Sortilin in WBCs', 'timeFrame': '97 weeks', 'description': 'The overall change from baseline in Sortilin in WBCs.'}, {'measure': 'Latozinemab Concentration in Serum', 'timeFrame': '97 weeks', 'description': 'Serum concentration of Latozinemab at week 97.'}, {'measure': 'Cmax of Latozinemab at Specified Timepoints', 'timeFrame': '97 weeks', 'description': 'Maximum observed concentration of Latozinemab at week 96 of treatment.'}, {'measure': 'Ctrough of Latozinemab at Specified Timepoints', 'timeFrame': '97 weeks', 'description': 'Trough concentration of Latozinemab at week 96 of treatment'}, {'measure': 'ARCmax of Latozinemab', 'timeFrame': '61 weeks', 'description': 'Ratio of latozinemab Cmax at week 61 to the Cmax at week 1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frontotemporal Dementia']}, 'descriptionModule': {'briefSummary': 'A Phase 2 open label study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL001 in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.', 'detailedDescription': 'This is a Phase 2, multicenter, open label study evaluating the safety, tolerability, PK and PD of AL001 administered intravenously in participants with a Granulin mutation or C9orf72 mutation causative of frontotemporal dementia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At screening, female participants must be nonpregnant and nonlactating\n* In good physical health on the basis of no clinically significant findings from medical history, physical examinations (PEs), laboratory tests, ECGs, and vital signs.\n* Participant is a carrier of a loss of function progranulin gene (GRN) mutation or carrier of a hexanucleotide repeat expansion C9orf72 mutation\n\nExclusion Criteria:\n\n* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.\n* History of alcohol abuse or substance abuse\n* Participant resides in a skilled nursing facility, convalescent home, or long term care facility'}, 'identificationModule': {'nctId': 'NCT03987295', 'briefTitle': 'A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alector Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia', 'orgStudyIdInfo': {'id': 'AL001-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Granulin and C9orf72', 'description': 'IV administration of AL001; 60 mg/kg, every 4 weeks \\[q4w\\]', 'interventionNames': ['Drug: AL001']}], 'interventions': [{'name': 'AL001', 'type': 'DRUG', 'description': '60 mg/kg of AL001 every 4 weeks', 'armGroupLabels': ['Granulin and C9orf72']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': "The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases UT Health San Antonio", 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "Lawson Health Research Institute, St. Joseph's", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Technical University of Munich', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'University of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'University of Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '1081GN', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Brain Research Center - PPDS', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': 'WC1N 3BG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Peter Ljubenkov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alector Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}