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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030396
Receipt No. 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

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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
Email 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
Email makochan.0401@gmail.com

Sponsor
Institute Nagoya University, Department of Neurology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034576

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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