Clinical trial NCT05579301: Study of Comprehensive ANd Multimodal Marker-based Cohort of Progressive Supranuclear Palsy(PSP)
Official title: Biomarker Development for Progressive Supranuclear Palsy Through Multi-dimensional SNU-PSP Cohort Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Progressive Supranuclear Palsy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2022-10-13
Enrollment: 130
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Number of Target population

Patient group: 100, Healthy control group: 30

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.

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

Primary outcomes:
measure: Change in the Progressive Supranuclear Palsy Rating Scale (PSP-RS)
timeFrame: From the baseline to 6 months and 12 months follow-up
Secondary outcomes:
measure: Change in the Schwab & England Activity of Daily Living scale (SEADL)
timeFrame: From the baseline to 6 months and 12 months follow-up
measure: Change in cognitive battery for seoul neuropsychological screening battery (SNSB-2) scale
timeFrame: From the baseline to 6 months and 12 months follow-up
measure: Change in MoCA (Montreal cognitive assessment)
timeFrame: From the baseline to 6 months and 12 months follow-up
measure: Change in MMSE(Mini-mental state examination)
timeFrame: From the baseline to 6 months and 12 months follow-up
Other outcomes:
measure: FDG PET (18Fluorodeoxyglucose)
timeFrame: From the baseline to 12 months follow-up
measure: Tau PET (18F-taucipir)
timeFrame: From the baseline to 12 months follow-up
measure: Structural analysis by 3T MRI
timeFrame: From the baseline to 12 months follow-up
measure: Change in p-tau 181
timeFrame: From the baseline to 12 months follow-up
measure: total tau (T-tau)
timeFrame: From the baseline to 12 months follow-up
measure: Amyloid beta 42 (Aβ-42)
timeFrame: From the baseline to 12 months follow-up
measure: Proteomic markers
timeFrame: From the baseline to 12 months follow-up
measure: Genomic markers
timeFrame: Baseline
measure: Retina biomarkers by OCT imaging
timeFrame: From the baseline to 12 months follow-up
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jee-Young Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: