Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia

Phase 2Not Yet RecruitingNCT07154485

Hee-Jin Kim15 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dementia Frontotemporal

Interventions

NS101 IV infusionDRUG

NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases

Placebo IV InfusionDRUG

Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)

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.

Time frame: Every Visit for 12month(48weeks)

Secondary Outcomes

Plasma FAM19A5 Concentration

To assess the pharmacodynamic (PD) effect of NS101 compared to placebo in patients with svPPA

Time frame: Every Visit for 12month(48weeks)

Minimum Plasma Concentration of NS101 (Cmin, Ctrough)

To evaluate the pharmacokinetics (PK) of repeated administration of NS101 compared to placebo in patients with svPPA

Time frame: Every Visit for 12month(48weeks)

Anti-Drug Antibodies (ADA)

To evaluate immunogenicity following repeated administration of NS101 compared to placebo

Time frame: Every Visit for 12month(48weeks

Neutralizing Antibodies (NAbs)

To evaluate the presence of neutralizing antibodies following repeated administration of NS101 compared to placebo

Time frame: Every Visit for 12month(48weeks)

Data from ClinicalTrials.gov

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