NCT07154485

Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia

A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Investigator-initiated Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD), and Exploratory Efficacy of Multiple Doses of NS101 in Patients With Semantic Variant Primary Progressive Aphasia (svPPA), a Subtype of Frontotemporal Dementia (FTD)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Hee-Jin Kim · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Dementia Frontotemporal

Interventions

Type	Name	Description
DRUG	NS101 IV infusion	NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
DRUG	Placebo IV Infusion	Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-09-04
• Last updated: 2025-09-04