Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07154485 | Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia | PHASE2 | NOT YET_RECRUITING | 15 | — | — | Oct 1, 2025 | Aug 1, 2028 | Sep 4, 2025 | - | — |
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| NS101 IV infusion | DRUG | NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases |
| Placebo IV Infusion | DRUG | Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101 |
Key Inclusion Criteria: * Participants diagnosed at screening with mild to moderate frontotemporal dementia, semantic variant (svFTD), defined by a CDR® Plus NACC FTLD Sum of Boxes (SOB) score between 4.5 and 15.5. * Participants confirmed to be amyloid-negative based on Amyloid PET scan or CSF res...