UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030396 |
|---|---|
| Receipt number | R000034576 |
| Scientific Title | Prospective study on early diagnosis of Parkinson's disease in medical checkup examinees with non-motor symptoms |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2018/06/19 11:47:03 |
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Basic information
Public title
Prospective study on early diagnosis of Parkinson's disease in medical checkup examinees with non-motor symptoms
Acronym
NaT-PROBE
Scientific Title
Prospective study on early diagnosis of Parkinson's disease in medical checkup examinees with non-motor symptoms
Scientific Title:Acronym
NaT-PROBE
Region
| Japan |
Condition
Condition
Parkinson's disease
Dementia with Lewy Bodies
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the incidence of Parkinson's disease between the two groups
1) examinees of medical checkups who have two or more non-motor symptoms
2) examinees of medical checkups without non-motor symptoms
Basic objectives2
Others
Basic objectives -Others
Diagnosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Parkinson's disease during the 10 year follow-up period
Key secondary outcomes
Changes in H/M ratio of MIBG scintigraphy during the 10 year follow-up period
Changes in SBR of DaT scan during the 10 year follow-up period
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Skin biopsy, MIBG scintigraphy and DaT scan
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Examinees of medical checkups who answered the questionnaire about non-motor symptoms of Parkinson disease
Subjects who can make a outpatient visit regularly
Subjects who agreed to participate in this study
Subjects who fulfill one of the following criteria
1) participants who have two or more non-motor symptoms: SCOPAAUT, 9 or more; SAOQ, 85 or less; RBDSQ, 4 or more.
2) participants who don't have any non-motor symptoms: SCOPA-AUT, SAOQ, RBDSQ, BDI-2 and JESS scores are all normal.
Key exclusion criteria
Subjects who have mental and neurological disorders other than depression
Subjects who are inappropriate to participate in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahisa Katsuno |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi, Japan
TEL
052-744-2391
ka2no@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Hattori |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi, Japan
TEL
052-744-2391
Homepage URL
makochan.0401@gmail.com
Sponsor or person
Institute
Nagoya University, Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | 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
| 2017 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 14 | Day |
Last modified on
| 2018 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034576
| 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 |
