Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia
ConditionDementia Frontotemporal
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-80
SponsorHee-Jin Kim
About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
Participants with other degenerative brain diseases as determined by the investigator
Participants with other neurological disorders and uncontrolled acute disease
Trial design
Treatments tested in this trial
- NS101 IV infusion
- Placebo IV Infusion
Treatment groups
15 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Hee-Jin Kim
Lead sponsor
Hanyang University Seoul Hospital
Sponsor institution
Asan Medical Center
Collaborator
Gangnam Severance Hospital
Collaborator
Konkuk University Medical Center
Collaborator
Source ClinicalTrials.gov