UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005475 |
|---|---|
| Receipt number | R000006495 |
| Scientific Title | Mapping of brain cholinergic and dopaminergic alternations in rapid eye movement (REM) sleep behavior disorder by PET |
| Date of disclosure of the study information | 2011/04/21 |
| Last modified on | 2020/05/11 18:17:42 |
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Basic information
Public title
Mapping of brain cholinergic and dopaminergic alternations in rapid eye movement (REM) sleep behavior disorder by PET
Acronym
Mapping of brain cholinergic and dopaminergic alternations in RBD by PET
Scientific Title
Mapping of brain cholinergic and dopaminergic alternations in rapid eye movement (REM) sleep behavior disorder by PET
Scientific Title:Acronym
Mapping of brain cholinergic and dopaminergic alternations in RBD by PET
Region
| Japan |
Condition
Condition
Healthy volunteer, RBD and Parkinson's disease (50<=age<=88)
Classification by specialty
| Neurology | Psychiatry | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize brain dopaminergic and cholinergic deficits in REM related behavior disorders (RBD) and Parkinson disease (PD).
Basic objectives2
Others
Basic objectives -Others
To characterize brain dopaminergic and cholinergic deficits in REM related behavior disorders (RBD) and Parkinson disease (PD).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative measurement of brain dopamine transporter binding and brain acetylcholinesterase activity in PET
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET/MRI/psychological batteries/neurological examinations
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
| 50 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[healthy volunteer]
50y.o.<=Age<=88y.o., cognitive normal subjects without severe physical complication
[Rapid eye movement behavior disorder (RBD)]
50y.o.<=Age<=88y.o., patients diagnosed with RBD according to the International Clasiffication of Sleep Disorders: second edition (ICSD-2) [Westchester.2005]
[Parkinson's disease (PD)]
50y.o.<=Age<=88y.o., patients diagnosed with PD according to UK brain bank Parkinson's disease diagnostic criteria [Hughes AJ.1992]
Key exclusion criteria
[RBD]
[PD]
1.psychiatric complications such as drug abuse
2.other organic brain complications such as symptomatic stroke, PD-related disorders and other neurodegenrative diseases
3.severe physical complications
4.exclude the patients who are recognized as inadequate patients by doctors with resposibility in this study
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | hitoshi |
| Middle name | |
| Last name | Shimada |
Organization
National Institute of Radiological Sciences (NIRS), National Institutes for Quantum and Radiological Science and Technology (QST)
Division name
Department of Functional Brain Imaging Research
Zip code
263-8555
Address
Chiba
TEL
0432063251
shimada.hitoshi@qst.go.jp
Public contact
Name of contact person
| 1st name | kazuko |
| Middle name | |
| Last name | Suzuki |
Organization
QST Hospital, National Institutes for Quantum and Radiological
Division name
Clinical Research Support Section
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
+81-(0)43-206-3025
Homepage URL
suzuki.kazuko@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences (NIRS), National Institutes for Quantum and Radiological Science and Technology (QST)
Institute
Department
Personal name
Funding Source
Organization
a consignment expense for Molecular Imaging Program on "Research Base for PET diagnosis" from the Ministry of Education,
Culture, Sports, Science and Technology (MEXT), Japanese Government
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
QST
Address
4-9-1 Anagawa, Inage-ku
Tel
0432063251
shimada.hitoshi@qst.go.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
http://www.nirs.qst.go.jp/seika/brain/english/index.html
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
36
Results
NA
Results date posted
| 2020 | Year | 05 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
none
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 21 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006495
