Leukoencephalopathy
Conditions
Brief summary
Safety and tolerability, as assessed by the following: Nature and frequency of adverse events, serious adverse events, and discontinuations due to adverse events; Safety laboratory tests; Immunogenicity tests; Vital sign measurements; Electrocardiograms; Columbia-Suicide Severity Rating Scale (C-SSRS)
Detailed description
Secondary end pointT Change from Baseline to Week 24 and Week 52 in structural and volumetric magnetic resonance imaging (MRI)Change from Baseline to Week 24 in neurofilament light chain (NfL) in cerebrospinal fluid (CSF) and blood, Change from Baseline to Week 24 and Week 52 in neurofilament light chain (NfL) in cerebrospinal fluid (CSF) and blood, Change from Baseline to Week 24 and Week 52 in in soluble colony-stimulating factor 1 receptor (sCSF1R) in CSF, Correlations of Week 24 and Week 52 biomarker changes and clinical outcomes
Interventions
DRUGVGL101
Sponsors
Vigil Neuroscience Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, as assessed by the following: Nature and frequency of adverse events, serious adverse events, and discontinuations due to adverse events; Safety laboratory tests; Immunogenicity tests; Vital sign measurements; Electrocardiograms; Columbia-Suicide Severity Rating Scale (C-SSRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end pointT Change from Baseline to Week 24 and Week 52 in structural and volumetric magnetic resonance imaging (MRI)Change from Baseline to Week 24 in neurofilament light chain (NfL) in cerebrospinal fluid (CSF) and blood, Change from Baseline to Week 24 and Week 52 in neurofilament light chain (NfL) in cerebrospinal fluid (CSF) and blood, Change from Baseline to Week 24 and Week 52 in in soluble colony-stimulating factor 1 receptor (sCSF1R) in CSF, Correlations of Week 24 and Week 52 biomarker changes and clinical outcomes | — |
Countries
France, Germany, Netherlands
Outcome results
None listed