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

Progressive Supranuclear Palsy Clinical Trial

— SCAN-PSP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579301
• Other study ID #: SNUH_2022_0117
• Status: Recruiting
• Start date: December 19, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: Jee-Young Lee, M.D.
• Phone: 82-2-870-2476
• Email: wieber77[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this cohort study is to develop a reliable biomarker in progressive nuclear palsy (PSP).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 28, 2025
• Est. primary completion date: December 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boramae Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	FDG PET (18Fluorodeoxyglucose)	Evaluation of metabolic activity and patterns of the brain	From the baseline to 12 months follow-up
Other	Tau PET (18F-taucipir)	Evaluation of the tau aggregation in the brain	From the baseline to 12 months follow-up
Other	Structural analysis by 3T MRI	Evaluation of the degenerative change in the brain	From the baseline to 12 months follow-up
Other	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
Other	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
Other	Amyloid beta 42 (Aß-42)	Change in serum and/or plasma Amyloid beta 42 (Aß-42) in PSP patients	From the baseline to 12 months follow-up
Other	Proteomic markers	Change in blood-based proteomic markers	From the baseline to 12 months follow-up
Other	Genomic markers	Identification of genetic markers in PSP that differentiates individuals with different clinical presentation and progression.	Baseline
Other	Retina biomarkers by OCT imaging	Exploratory analysis of OCT and OCTA imaging	From the baseline to 12 months follow-up
Primary	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	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
Secondary	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
Secondary	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
Secondary	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