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Not yet recruiting NCT07154485

Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia

Phase II Interventional Dementia Frontotemporal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NS101 IV infusion, Placebo IV Infusion.
Who it may be relevant to
Registry conditions: Dementia Frontotemporal. Basic parameters: 55 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

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)

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

Primary outcome measures

  • Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) [Time frame: Every Visit for 12month(48weeks)]
Secondary outcome measures (4)
  • Plasma FAM19A5 Concentration [Time frame: Every Visit for 12month(48weeks)]
  • Minimum Plasma Concentration of NS101 (Cmin, Ctrough) [Time frame: Every Visit for 12month(48weeks)]
  • Anti-Drug Antibodies (ADA) [Time frame: Every Visit for 12month(48weeks]
  • Neutralizing Antibodies (NAbs) [Time frame: Every Visit for 12month(48weeks)]

Eligibility criteria

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

  • Participants with other degenerative brain diseases as determined by the investigator
  • Participants with other neurological disorders and uncontrolled acute disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07154485 · NS101_I2a_FTD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗