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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0011077

Enrollment

Registered

2025-10-29

Start date

2025-11-10

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In this study, patients with mild to moderate semantic variant frontotemporal dementia will be randomized in a 2:1 ratio to Cohort A (NS101) or Cohort B (placebo). Participants will receive two

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 results within the past 36 months.

Exclusion criteria

Exclusion criteria: Key Exclusion Criteria: • Participants with other degenerative brain diseases as determined by the investigator • Participants with other neurological disorders and uncontrolled acute disease

Design outcomes

Primary

Measure	Time frame
Assessment of percentage of AEs, SAEs and serious ADRs by group ;Assessment of correlation between AEs, SAEs and serious ADRs by group ;Assessment of severity of AEs, SAEs and serious ADRs by group	—

Secondary

Measure	Time frame
Pharmacokinetics;Pharmacodynamics;Immunogenicity;Change in neuropsychological test results;Change in audiological test results;Change in biomarker test results;Change in radiological (imaging) examination results;Change in CDR-FTLD scores	—

Countries

Korea, Republic of

Contacts

Public ContactHeejin KIM

Hanyang University Seoul Hospital

hyumcbrain@hanyang.ac.kr+82-2-2290-8374

Outcome results