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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036570
Receipt No. R000041617
Scientific Title Prospective and exploratory study for disease specific biomarkers and objective indicators in neurodegenerative diseases
Date of disclosure of the study information 2019/04/22
Last modified on 2019/04/16

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Basic information
Public title Prospective and exploratory study for disease specific biomarkers and objective indicators in neurodegenerative diseases
Acronym Prospective study for biomarkers in neurodegenerative diseases
Scientific Title Prospective and exploratory study for disease specific biomarkers and objective indicators in neurodegenerative diseases
Scientific Title:Acronym Prospective study for biomarkers in neurodegenerative diseases
Region
Japan

Condition
Condition All Neurodegenerative diseases specifically Parkinson's disease, corticobasal degeneration and progressive supranuclear palsy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to establish imaging, biochemical or physiological biomarkers, which can provide diagnosis, staging and prediction for prognosis of neurodegenerative diseases including/?specifically Parkinson's syndrome/?parkinsonian symptoms
Basic objectives2 Others
Basic objectives -Others Exploratory
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Assessment of parkinsonism (MDS-UPDRS score, Hoehn-Yahr stage)
Key secondary outcomes Cognitive evaluation (MMSE, Visual Perspective test, etc.), Brain imaging evaluation (structural MRI , functional MRI, etc.) and biochemical markers of cerebrospinal fluid and serum (catecholamine concentration, alpha-synuclein concentration, cerebrospinal fluid amyloid aggregation, etc.)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients over 18 years old with parkinsonism, who provided (by own or by a representative) a written informed consent. Parkinsonism is defined as two or more symptoms in tremor, akinesia, muscular rigidity, and postural reflex disorder, which show a slow progressive course. As a disease control, this study also targets at patients who receive spinal fluid drainage to prevent spinal cord ischemia among thoracoabdominal surgery.
Key exclusion criteria None
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Mochizuki
Organization Osaka University Graduate School of Medicine
Division name Neurology
Zip code 565-0871
Address 2-2, Yamadaoka, Suita City, Osaka Prefecture
TEL +(81)-6-6879-3571
Email crgou@neurol.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Noriaki
Middle name
Last name Hattori
Organization Osaka University Graduate School of Medicine
Division name Neurology
Zip code 565-0871
Address 2-2, Yamadaoka, Suita City, Osaka Prefecture
TEL +(81)-6-6879-3571
Homepage URL
Email crgou@neurol.med.osaka-u.ac.jp

Sponsor
Institute Department of Neurology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address Center of Medical Innovation and Translational Research 4F, 2-2, Yamadaoka, Suita City, Osaka Prefecture
Tel 06-6210-8289
Email rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 08 Day
Date of IRB
2014 Year 05 Month 08 Day
Anticipated trial start date
2014 Year 05 Month 08 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients over 18 years old with parkinsonism, who provided (by own or by a representative) a written informed consent. Parkinsonism is defined as two or more symptoms in tremor, akinesia, muscular rigidity, and postural reflex disorder, which show a slow progressive course. As a disease control, this study also targets at patients who receive spinal fluid drainage to prevent spinal cord ischemia among thoracoabdominal surgery.
Recruitment is conducted for patients who visit Department of Neurology, Osaka University Hospital after May 8, 2014.

Management information
Registered date
2019 Year 04 Month 22 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041617

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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