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

NCT05579301 | Unknown

• 1 other identifier: SNUH_2022_0117
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the Schwab & England Activity of Daily Living scale (SEADL)

  From the baseline to 6 months and 12 months follow-up

• Change in cognitive battery for seoul neuropsychological screening battery (SNSB-2) scale

  From the baseline to 6 months and 12 months follow-up

• Change in MoCA (Montreal cognitive assessment)

  From the baseline to 6 months and 12 months follow-up

• Change in MMSE(Mini-mental state examination)

  From the baseline to 6 months and 12 months follow-up

Other Outcomes (9)

• FDG PET (18Fluorodeoxyglucose)

  From the baseline to 12 months follow-up

• Tau PET (18F-taucipir)

  From the baseline to 12 months follow-up

• Structural analysis by 3T MRI

  From the baseline to 12 months follow-up

Study Arms (2)

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

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Number of Target population Patient group: 100, Healthy control group: 30

You may qualify if:

• 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)

You may not qualify if:

• 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)
• Age 50 to 80 years, male or female
• Those who agreed to participate in this study
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (2)

Seoul National University Boramae Hospital

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jee-Young Lee, M.D.

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jee-Young Lee, M.D.

CONTACT

82-2-870-2476; wieber77@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: October 13, 2022
• Study Start: December 19, 2021
• Primary Completion: December 19, 2024
• Study Completion: February 28, 2025
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)