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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Gangnam Severance Hospital | OTHER |
| Konkuk University Medical Center | OTHER |
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The purpose of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), immunogenicity, and efficacy of multiple intravenous administrations of the investigational drug NS101, compared to placebo, in patients with semantic variant primary progressive aphasia (svPPA), a subtype of frontotemporal dementia (FTD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NS101 Treatment Group | Active Comparator | Participants will receive a two loading dose of NS101 15 mg/kg IV infusion, followed by biweekly dosing for 6 months during the double-blind phase. Those who complete the double-blind phase will be eligible to enter a 3-month open-label extension to receive active treatment. |
|
| NS101 Placebo Group | Placebo Comparator | Participants will receive a two loading dose of NS101 15 mg/kg IV infusion, followed by biweekly dosing for 6 months during the double-blind phase. Those who complete the double-blind phase will be eligible to enter a 3-month open-label extension to receive active treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NS101 IV infusion | Drug | NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | To evaluate the safety and tolerability of repeated administration of NS101 compared to placebo in patients with semantic variant primary progressive aphasia (svPPA), a subtype of frontotemporal dementia (FTD). <primary efficacy endpoint> The incidence, causality, and severity of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious adverse drug reactions (SADRs) by group. | Every Visit for 12month(48weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma FAM19A5 Concentration | To assess the pharmacodynamic (PD) effect of NS101 compared to placebo in patients with svPPA | Every Visit for 12month(48weeks) |
| Minimum Plasma Concentration of NS101 (Cmin, Ctrough) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Neuropsychological Test Scores (FAB) | Neuropsychological assessment - Score on Frontal Assessment Battery (FAB) | Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48 |
| Change from Baseline in Biomarkers |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| ID | Term |
|---|---|
| D020774 | Pick Disease of the Brain |
| D057180 | Frontotemporal Dementia |
| ID | Term |
|---|---|
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo IV Infusion | Drug | Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101 |
|
To evaluate the pharmacokinetics (PK) of repeated administration of NS101 compared to placebo in patients with svPPA
| Every Visit for 12month(48weeks) |
| Anti-Drug Antibodies (ADA) | To evaluate immunogenicity following repeated administration of NS101 compared to placebo | Every Visit for 12month(48weeks |
| Neutralizing Antibodies (NAbs) | To evaluate the presence of neutralizing antibodies following repeated administration of NS101 compared to placebo | Every Visit for 12month(48weeks) |
Biomarkers
|
| Changes from baseline at each assessment time point • Screening, Week 24, Week 36, Week48 |
| Change from Baseline in Brain MRI | Neuroimaging - Brain MRI Measures With Functional MRI (fMRI) | Changes from baseline at each assessment time point • Screening, Week 24, Week 36, Week48 |
| Change From Baseline in Neuropsychological Test Scores (BNT/WAB) | Neuropsychological assessment - Score on Boston Naming Test (BNT) or Western Aphasia Battery (WAB) | Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48 |
| Change From Baseline in Neuropsychological Test Scores (ADCS-ADL) | Neuropsychological assessment - Score on Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48 |
| Change From Baseline in Neuropsychological Test Scores (FBI) | Neuropsychological assessment - Score on Frontal Behavioral Inventory (FBI) | Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48 |
| Change From Baseline in Neuropsychological Test Scores (C-SSRS) | Neuropsychological assessment - Score on Columbia-Suicide Severity Rating Scale (C-SSRS) | Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48 |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D057177 | TDP-43 Proteinopathies |
| D019636 | Neurodegenerative Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |