Not yet recruitingPhase 2

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)

Lead sponsor

Hee-Jin Kim

Asset

NS101

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Frontotemporal dementia

Key I/E criteria

•Amyloid biomarker required (PET/CSF)•CDR-SB 4.5-15.5

Primary endpoint

•Treatment-Emergent Adverse Events

Identifiers

Registered as

NCT IDNCT07154485

Org study IDNS101_I2a_FTD

Timeline

Milestones

Study first posted2025-09-04actual

Last update posted2025-09-04actual

Study start2025-10-01estimated

Primary completion2027-08-01estimated

Study completion2028-08-01estimated

Assets

Drug assets

NS101

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age55 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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

•Participants with other degenerative brain diseases as determined by the investigator

•Participants with other neurological disorders and uncontrolled acute disease

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Executive function / language

Safety / tolerability / PK

Function / daily living

Neurodegeneration biomarkers

Neuroimaging

Executive function / language

3 endpoints

Primary/protocol endpoint

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

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

event count, event

Other/protocol endpoint

Change From Baseline in Neuropsychological Test Scores (FAB)

Time frame:Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Neuropsychological Test Scores (BNT/WAB)

Time frame:Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48

change from baseline, improvement

Function / daily living

1 endpoint

Other/protocol endpoint

Change From Baseline in Neuropsychological Test Scores (ADCS-ADL)

Time frame:Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Neurodegeneration biomarkers

1 endpoint

Other/protocol endpoint

Change from Baseline in Biomarkers

Time frame:Changes from baseline at each assessment time point • Screening, Week 24, Week 36, Week48

Neurofilament light (NfL)

change from baseline, improvement

Neuroimaging

1 endpoint

Other/protocol endpoint

Change from Baseline in Brain MRI

Time frame:Changes from baseline at each assessment time point • Screening, Week 24, Week 36, Week48

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Minimum Plasma Concentration of NS101 (Cmin, Ctrough)

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

concentration, descriptive

Secondary/protocol endpoint

Anti-Drug Antibodies (ADA)

Time frame:Every Visit for 12month(48weeks

ratio, event

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Plasma FAM19A5 Concentration

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

concentration, descriptive

Secondary/protocol endpoint/low confidence

Neutralizing Antibodies (NAbs)

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

ratio, descriptive

Other/protocol endpoint/low confidence

Change From Baseline in Neuropsychological Test Scores (FBI)

Time frame:Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48

change from baseline, improvement

Other/protocol endpoint/low confidence

Change From Baseline in Neuropsychological Test Scores (C-SSRS)

Time frame:Changes from baseline at each assessment time point - Screening, Week 24, Week 36, Week48

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.