UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012988 |
|---|---|
| Receipt number | R000015032 |
| Scientific Title | Pathophysiological analysis of Parkinson disease using DAT scan and MRI |
| Date of disclosure of the study information | 2014/01/28 |
| Last modified on | 2016/08/02 09:34:06 |
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Basic information
Public title
Pathophysiological analysis of Parkinson disease using DAT scan and MRI
Acronym
Neuroimaging analysis of Parkinson disease
Scientific Title
Pathophysiological analysis of Parkinson disease using DAT scan and MRI
Scientific Title:Acronym
Neuroimaging analysis of Parkinson disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology | Radiology | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know the role of dopamine in vivo
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine lesions of decrease of dopamine
Key secondary outcomes
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy control
Patients with Parkinson disease
Key exclusion criteria
1. communication disorder
2. serious condition of vital sign
3. no consent
4. cardiac pacemaker
5. implanted metallic or electrical devices
6. taking medicine which affects the uptake of [123I]-Ioflupane
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryosuke Takahashi |
Organization
Kyoto University Graduated School of Medicine
Division name
Department of Neurology
Zip code
Address
Kawara-machi 54, Shogo-in, Sakyo-ku, Kyoto, Japan
TEL
075-751-3771
sawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobukatsu Sawamoto |
Organization
Kyoto University Graduated School of Medicine
Division name
Department of Neurology
Zip code
Address
Kawara-machi 54, Shogo-in, Sakyo-ku, Kyoto, Japan
TEL
075-751-3771
Homepage URL
sawa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Kyoto University Graduated School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Neurotransmission and research of brain function
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 01 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 01 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2014 | Year | 01 | Month | 28 | Day |
Last modified on
| 2016 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015032
