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

Recruiting

• Conditions: Progressive Supranuclear Palsy

• Registration Number: NCT05579301
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2021-12-19
• Study First Submitted: 2022-06-20
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-11
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2024-12-19
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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

Trial Locations

Locations (2)

Seoul National University Boramae Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of