Neurodegenerative Diseases
Conditions
Keywords
Frontotemporal Dementia (FTD), Amyotrophic Lateral Sclerosis (ALS)
Brief summary
Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study
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).
Interventions
DRUGLatozinemab
All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks
Sponsors
Alector Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open label continuation study
Intervention model description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants receiving latozinemab | Through study completion, up to 190 weeks | Number of participants receiving latozinemab |
| Duration of treatment with latozinemab | Through study completion, up to 190 weeks | Duration of treatment with latozinemab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incident of adverse events (AEs) and serious adverse events (SAEs) | Through study completion, up to 190 weeks | Number and percentage of participants of AEs or SAEs |
| Nature and severity of AEs and SAEs | Through study completion, up to 190 weeks | Severity of AEs and SAEs according to the World Health Organization (WHO) toxicity grading scale |
| Incidence of ADAs to latozinemab | Through study completion, up to 190 weeks | Number and percentage of participants with anti-Drug Antibodies (ADA) titer over study time points |
Countries
Belgium, Canada, France, Germany, Italy, Netherlands, Portugal, Sweden, United Kingdom, United States
Contacts
STUDY_DIRECTORStudy Lead
Alector Inc.
Outcome results
None listed