UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036570 |
|---|---|
| Receipt number | 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 | 2023/04/11 14:23:37 |
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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
crgou@neurol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Ogawa |
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
crgou@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
| 2025 | 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
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041617
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
