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| Name | Class |
|---|---|
| SMG-SNU Boramae Medical Center | OTHER |
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The purpose of this cohort study is to develop a reliable biomarker in progressive nuclear palsy (PSP).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the baseline to 6 months and 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the baseline to 6 months and 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| FDG PET (18Fluorodeoxyglucose) | Evaluation of metabolic activity and patterns of the brain | From the baseline to 12 months follow-up |
| Tau PET (18F-taucipir) | Evaluation of the tau aggregation in the brain |
Inclusion Criteria for the patient group:
Exclusion Criteria for the patient group:
Inclusion Criteria for the healthy control group:
Exclusion Criteria for the healthy control group:
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Number of Target population
Patient group: 100, Healthy control group: 30
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jee-Young Lee, M.D. | Contact | 82-2-870-2476 | wieber77@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jee-Young Lee, M.D. | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Boramae Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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For participants enrolled in the cohort, a baseline blood sample will be collected and stored for analyses in the future. Blood will also be stored for high throughput 'omics (transcriptomics, genomics and proteomics) to develop new biomarkers for diagnosis and disease progression.
| 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. |
| 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 | 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 | From the baseline to 6 months and 12 months follow-up |
| From the baseline to 12 months follow-up |
| Structural analysis by 3T MRI | Evaluation of the degenerative change in the brain | From the baseline to 12 months follow-up |
| Change in p-tau 181 | Change in serum and/or plasma phosphorylated tau (p-tau181) in PSP patients | From the baseline to 12 months follow-up |
| total tau (T-tau) | Change in serum and/or plasma total tau (T-tau) in PSP patients | From the baseline to 12 months follow-up |
| Amyloid beta 42 (Aβ-42) | Change in serum and/or plasma Amyloid beta 42 (Aβ-42) in PSP patients | From the baseline to 12 months follow-up |
| Proteomic markers | Change in blood-based proteomic markers | From the baseline to 12 months follow-up |
| Genomic markers | Identification of genetic markers in PSP that differentiates individuals with different clinical presentation and progression. | Baseline |
| Retina biomarkers by OCT imaging | Exploratory analysis of OCT and OCTA imaging | From the baseline to 12 months follow-up |
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |