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Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia

NCT07154485 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Gangnam Severance Hospital

    collaborator OTHER

  • Konkuk University Medical Center

    collaborator OTHER

  • Hee-Jin Kim

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-08-01
Completion
2028-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154485 on ClinicalTrials.gov