Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia

Hee-Jin Kim

Status and phase: Not yet enrolling; Phase 2

Conditions: Dementia Frontotemporal

Treatments: Drug: Placebo IV Infusion; Drug: NS101 IV infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07154485

NS101_I2a_FTD

Details and patient eligibility

About

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)

Enrollment: 15 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Key Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

NS101 Treatment Group

Active Comparator group

Description:

Participants will receive a two loading dose of NS101 15 mg/kg IV infusion, followed by biweekly dosing for 6 months during the double-blind phase. Those who complete the double-blind phase will be eligible to enter a 3-month open-label extension to receive active treatment.

Treatment:

Drug: NS101 IV infusion

NS101 Placebo Group

Placebo Comparator group

Description:

Participants will receive a two loading dose of NS101 15 mg/kg IV infusion, followed by biweekly dosing for 6 months during the double-blind phase. Those who complete the double-blind phase will be eligible to enter a 3-month open-label extension to receive active treatment.

Treatment:

Drug: Placebo IV Infusion