Dementia FrontotemporalPhase 2NCT07154485
Investigator Initiated Study for the Safety and Efficacy in Frontotemporal Dementia
A Phase 2 study testing NS101 IV infusion in people with Dementia Frontotemporal, run by Hee-Jin Kim.
Trial 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 investigational drug NS101, compared to placebo, in patients with semantic variant primary progressive aphasia (svPPA), a… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Dementia Frontotemporal
- What is being tested?
- NS101 IV infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants with other degenerative brain diseases as determined by the investigator
- Participants with other neurological disorders and uncontrolled acute disease
About this study
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)
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)
- Conditions
- Dementia Frontotemporal
- Being tested
- NS101 IV infusion, Placebo IV Infusion
- Keywords
- Frontotemporal Dementia, semantic variant, FTD, sv FTD, PPA, sv PPA
- Medical subject headings
- Pick Disease of the Brain, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS101 IV infusionDrug
NS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases
Placebo IV InfusionDrug
Placebo (i.e. fake drug without active pharmaceutical ingredient) of NS101
| Study group | Role | What they receive |
|---|---|---|
| NS101 Treatment Group | Active comparator | 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. Receives: Drug: NS101 IV infusion |
| NS101 Placebo Group | Placebo comparator | 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. Receives: Drug: Placebo IV Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
To evaluate the safety and tolerability of repeated administration of NS101 compared to placebo in patients with semantic variant primary progressive aphasia (svPPA), a subtype of frontotemporal dementia (FTD).
<primary efficacy endpoint> The incidence, causality, and severity of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious adverse drug reactions (SADRs) by group.
Measured: Every Visit for 12month(48weeks)
Secondary outcomes (4)
Plasma FAM19A5 Concentration
To assess the pharmacodynamic (PD) effect of NS101 compared to placebo in patients with svPPA
Measured: Every Visit for 12month(48weeks)
Minimum Plasma Concentration of NS101 (Cmin, Ctrough)
To evaluate the pharmacokinetics (PK) of repeated administration of NS101 compared to placebo in patients with svPPA
Measured: Every Visit for 12month(48weeks)
Anti-Drug Antibodies (ADA)
To evaluate immunogenicity following repeated administration of NS101 compared to placebo
Measured: Every Visit for 12month(48weeks
Neutralizing Antibodies (NAbs)
To evaluate the presence of neutralizing antibodies following repeated administration of NS101 compared to placebo
Measured: Every Visit for 12month(48weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia FrontotemporalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hee-Jin Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Gangnam Severance Hospital, Konkuk University Medical Center
- Responsible party
- Sponsor-investigator, Hee-Jin Kim, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154485
- Sponsor's protocol ID
- NS101_I2a_FTD
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07154485
- Acronym / sponsor ID
- NS101_I2a_FTD
- Conditions
- Dementia Frontotemporal
- Keywords
- Frontotemporal Dementia, semantic variant, FTD, sv FTD, PPA, sv PPA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hee-Jin KimUniversity, hospital or other
- Collaborators
- Asan Medical Center, Gangnam Severance Hospital, Konkuk University Medical Center
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NS101 Treatment Group | Active comparator | Drug: NS101 IV infusionParticipants 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. |
| NS101 Placebo Group | Placebo comparator | Drug: Placebo IV InfusionParticipants 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (2 listed)
- Participants with other degenerative brain diseases as determined by the investigator
- Participants with other neurological disorders and uncontrolled acute disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NS101 IV infusionNS101 is anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases | Drug | NS101 Treatment Group |
| Placebo IV InfusionPlacebo (i.e. fake drug without active pharmaceutical ingredient) of NS101 | Drug | NS101 Placebo Group |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Every Visit for 12month(48weeks)
To evaluate the safety and tolerability of repeated administration of NS101 compared to placebo in patients with semantic variant primary progressive aphasia (svPPA), a subtype of frontotemporal dementia (FTD). <primary efficacy endpoint> The incidence, causality, and severity of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious adverse drug reactions (SADRs) by group.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NS101 IV infusion in people with Dementia Frontotemporal, run by Hee-Jin Kim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: Every Visit for 12month(48weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.