Progressive Supranuclear PalsySCAN-PSPNCT05579301
Study of Comprehensive ANd Multimodal Marker-based Cohort of Progressive Supranuclear Palsy(PSP)
An observational study of Progressive Supranuclear Palsy, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The purpose of this cohort study is to develop a reliable biomarker in progressive nuclear palsy (PSP). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy
- How many people
- 130 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 19 Dec 2021to 28 Feb 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Number of Target population Patient group: 100, Healthy control group: 30
Who may be able to join
- Age 50 to 80 years, male or female
- Progressive supranuclear palsy (PSP) patients who are diagnosed as Probable, Possible or suggestive PSP with Movement Disorder society diagnostic criteria for PSP (Hoglinger et al., 2017)
- Age 50 to 80 years, male or female
- Those who agreed to participate in this study
Who cannot join
- Subjects with clinically significant psychiatric illness
- Subjects with cancer or severe medical illness
- Lactating, pregnant, or possibly pregnant
- Subjects with small vessel disease (> grade II) in brain MRI or other structural lesions by causes other than PSP
- Subjects with severe dementia patients (MMSE < 19 or MoCA <13 or General deterioration scale >= 5)
- Those with a history of any neurological diseases
Show all 9Show fewer
- Lactating, pregnant, or possibly pregnant
- Subjects with clinically significant psychiatric illness
- Subjects with cancer or severe medical illness
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Boramae Hospital
Seoul
Jee-Young Lee, MD, PhD., 82-2-870-2476, wieber77@gmail.com
Jee-Young Lee, M.D.
- Recruiting
Seoul National University Hospital
Seoul
Han-Joon Kim, MD, PhD, 82-02-2072-1219, movement@snu.ac.kr
Han-Joon Kim, M.D.
About this study
Official title: Biomarker Development for Progressive Supranuclear Palsy Through Multi-dimensional SNU-PSP Cohort Database
The purpose of this cohort study is to develop a reliable biomarker in progressive nuclear palsy (PSP).
Read the detailed description
Progressive supranuclear palsy is a rapidly progressive neurodegenerative disease without a cure. Thus, the development of a biomarker that reflects and monitors disease severity in PSP is critical for early diagnosis and performing a successful clinical trial. Thus, we will prospectively recruit patients with PSP and collect comprehensive clinical, imaging and blood biomarkers at baseline with longitudinal follow-up for 1 year.
- Conditions
- Progressive Supranuclear Palsy
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PSP patients | Patients with PSP according to the inclusion and exclusion criteria | |
| healthy controls | age-matched healthy controls according to the inclusion and exclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Progressive Supranuclear Palsy Rating Scale (PSP-RS)
A scale for assessment of motor and non-motor symptom severity in PSP patients. The PSPRS comprises 28-items with total score ranges from 0 (normal) to 100.
Measured: From the baseline to 6 months and 12 months follow-up
Secondary outcomes (4)
Change in the Schwab & England Activity of Daily Living scale (SEADL)
A scale for activity of daily living assessment that ranges from 0% (complete dependence) to 100% (total independence). The decline in the ADL percentage over time indicates worsening.
Measured: From the baseline to 6 months and 12 months follow-up
Change in cognitive battery for seoul neuropsychological screening battery (SNSB-2) scale
SNSB-2 measures 5 cognitive domain including memory, frontal executive function, attention, visuospatial, language. SNSB scores are provided as age, sex normalized score (z-score) which have a mean of 0 with standard deviation of 1. Higher score indicates better performance.
Measured: From the baseline to 6 months and 12 months follow-up
Change in MoCA (Montreal cognitive assessment)
MoCA scale measures global cognitive status including attention and concentration, executive function, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. MoCA score ranges from 0 to 30. Higher score indicates better performance
Measured: From the baseline to 6 months and 12 months follow-up
Change in MMSE(Mini-mental state examination)
MMSE scale measures global cognitive status that ranges from 0 to 30. Higher score indicates better performance
Measured: From the baseline to 6 months and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start19 Dec 2021
- Primary completion19 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jee-Young Lee, Seoul National University Hospital
- Investigators
- Jee-Young Lee, M.D., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579301
- Sponsor's protocol ID
- SNUH_2022_0117
- Acronym
- SCAN-PSP
- Status last verified
- Oct 2022
- First submitted
- 20 Jun 2022
- Last updated
- 13 Oct 2022
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Development for Progressive Supranuclear Palsy Through Multi-dimensional SNU-PSP Cohort Database
- ClinicalTrials.gov ID
- NCT05579301
- Acronym / sponsor ID
- SCAN-PSP / SNUH_2022_0117
- Conditions
- Progressive Supranuclear Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 19 Dec 2021 (actual)
- Primary completion
- 19 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 13 Oct 2022 (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 cohort study is to develop a reliable biomarker in progressive nuclear palsy (PSP).
Detailed description
Progressive supranuclear palsy is a rapidly progressive neurodegenerative disease without a cure. Thus, the development of a biomarker that reflects and monitors disease severity in PSP is critical for early diagnosis and performing a successful clinical trial. Thus, we will prospectively recruit patients with PSP and collect comprehensive clinical, imaging and blood biomarkers at baseline with longitudinal follow-up for 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSP patients | – | –Patients with PSP according to the inclusion and exclusion criteria |
| healthy controls | – | –age-matched healthy controls according to the inclusion and exclusion criteria |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Number of Target population Patient group: 100, Healthy control group: 30
Key inclusion criteria (4 listed)
- Age 50 to 80 years, male or female
- Progressive supranuclear palsy (PSP) patients who are diagnosed as Probable, Possible or suggestive PSP with Movement Disorder society diagnostic criteria for PSP (Hoglinger et al., 2017)
- Age 50 to 80 years, male or female
- Those who agreed to participate in this study
Key exclusion criteria (9 listed)
- Subjects with clinically significant psychiatric illness
- Subjects with cancer or severe medical illness
- Lactating, pregnant, or possibly pregnant
- Subjects with small vessel disease (> grade II) in brain MRI or other structural lesions by causes other than PSP
- Subjects with severe dementia patients (MMSE < 19 or MoCA <13 or General deterioration scale >= 5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the Progressive Supranuclear Palsy Rating Scale (PSP-RS)
Time frame: From the baseline to 6 months and 12 months follow-up
A scale for assessment of motor and non-motor symptom severity in PSP patients. The PSPRS comprises 28-items with total score ranges from 0 (normal) to 100.
4 secondary outcomes
Change in the Schwab & England Activity of Daily Living scale (SEADL)
Time frame: From the baseline to 6 months and 12 months follow-up
Change in cognitive battery for seoul neuropsychological screening battery (SNSB-2) scale
Time frame: From the baseline to 6 months and 12 months follow-up
Change in MoCA (Montreal cognitive assessment)
Time frame: From the baseline to 6 months and 12 months follow-up
Change in MMSE(Mini-mental state examination)
Time frame: From the baseline to 6 months and 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- 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. This study is not recruiting at the moment.
Jee-Young Lee, M.D. principal investigator
SMG-SNU Boramae Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Supranuclear Palsy, run by Seoul National University Hospital at 2 sites in South Korea.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jee-Young Lee, M.D. (82-2-870-2476, wieber77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Progressive Supranuclear Palsy Rating Scale (PSP-RS) (time frame: From the baseline to 6 months and 12 months follow-up). 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 13 Oct 2022.