SCAN-PSP: Study of Comprehensive ANd Multimodal Marker-based Cohort of Progressive Supranuclear Palsy(PSP)
Study Details
Study Description
Brief Summary
The purpose of this cohort study is to develop a reliable biomarker in progressive nuclear palsy (PSP).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Change in the Progressive Supranuclear Palsy Rating Scale (PSP-RS) [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.
Secondary Outcome Measures
- Change in the Schwab & England Activity of Daily Living scale (SEADL) [From the baseline to 6 months and 12 months follow-up]
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.
- Change in cognitive battery for seoul neuropsychological screening battery (SNSB-2) scale [From the baseline to 6 months and 12 months follow-up]
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.
- Change in MoCA (Montreal cognitive assessment) [From the baseline to 6 months and 12 months follow-up]
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
- Change in MMSE(Mini-mental state examination) [From the baseline to 6 months and 12 months follow-up]
MMSE scale measures global cognitive status that ranges from 0 to 30. Higher score indicates better performance
Other Outcome Measures
- FDG PET (18Fluorodeoxyglucose) [From the baseline to 12 months follow-up]
Evaluation of metabolic activity and patterns of the brain
- Tau PET (18F-taucipir) [From the baseline to 12 months follow-up]
Evaluation of the tau aggregation in the brain
- Structural analysis by 3T MRI [From the baseline to 12 months follow-up]
Evaluation of the degenerative change in the brain
- Change in p-tau 181 [From the baseline to 12 months follow-up]
Change in serum and/or plasma phosphorylated tau (p-tau181) in PSP patients
- total tau (T-tau) [From the baseline to 12 months follow-up]
Change in serum and/or plasma total tau (T-tau) in PSP patients
- Amyloid beta 42 (Aβ-42) [From the baseline to 12 months follow-up]
Change in serum and/or plasma Amyloid beta 42 (Aβ-42) in PSP patients
- Proteomic markers [From the baseline to 12 months follow-up]
Change in blood-based proteomic markers
- Genomic markers [Baseline]
Identification of genetic markers in PSP that differentiates individuals with different clinical presentation and progression.
- Retina biomarkers by OCT imaging [From the baseline to 12 months follow-up]
Exploratory analysis of OCT and OCTA imaging
Eligibility Criteria
Criteria
Inclusion Criteria for the patient group:
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Age 50 to 80 years, male or female
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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)
Exclusion Criteria for the patient group:
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Subjects with clinically significant psychiatric illness
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Subjects with cancer or severe medical illness
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Lactating, pregnant, or possibly pregnant
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Subjects with small vessel disease (> grade II) in brain MRI or other structural lesions by causes other than PSP
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Subjects with severe dementia patients (MMSE < 19 or MoCA <13 or General deterioration scale >= 5)
Inclusion Criteria for the healthy control group:
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Age 50 to 80 years, male or female
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Those who agreed to participate in this study
Exclusion Criteria for the healthy control group:
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Those with a history of any neurological diseases
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Lactating, pregnant, or possibly pregnant
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Subjects with clinically significant psychiatric illness
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Subjects with cancer or severe medical illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Boramae Hospital | Seoul | Korea, Republic of | ||
| 2 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
- SMG-SNU Boramae Medical Center
Investigators
- Principal Investigator: Jee-Young Lee, M.D., SMG-SNU Boramae Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNUH_2022_0117