Study of Comprehensive ANd Multimodal Marker-based Cohort of Progressive Supranuclear Palsy(PSP)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Biomarker Development for Progressive Supranuclear Palsy Through Multi-dimensional SNU-PSP Cohort Database

Conditions
-----------------
Progressive Supranuclear Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for the patient group: 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) Exclusion Criteria for the patient group: 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) Inclusion Criteria for the healthy control group: Age 50 to 80 years, male or female Those who agreed to participate in this study Exclusion Criteria for the healthy control group: Those with a history of any neurological diseases Lactating, pregnant, or possibly pregnant Subjects with clinically significant psychiatric illness Subjects with cancer or severe medical illness

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PSP patients<br>Patients with PSP according to the inclusion and exclusion criteria | |
| healthy controls<br>age-matched healthy controls according to the inclusion and exclusion criteria | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |