Status:
NOT_YET_RECRUITING
Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia
Lead Sponsor:
Hee-Jin Kim
Collaborating Sponsors:
Asan Medical Center
Gangnam Severance Hospital
Conditions:
Dementia Frontotemporal
Eligibility:
All Genders
55-80 years
Phase:
PHASE2
Brief Summary
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 inves...
Eligibility Criteria
Inclusion
- Key
- 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
- Participants with other degenerative brain diseases as determined by the investigator
- Participants with other neurological disorders and uncontrolled acute disease
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07154485
Start Date
October 1 2025
End Date
August 1 2028
Last Update
September 4 2025
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