Clinical Research Directory
Browse clinical research sites, groups, and studies.
Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia
Sponsor: Hee-Jin Kim
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)
Official title: 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)
Key Details
Gender
All
Age Range
55 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-10-01
Completion Date
2028-08-01
Last Updated
2025-09-04
Healthy Volunteers
No
Conditions
Interventions
NS101 IV infusion
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
Placebo IV Infusion
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101