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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016755
Receipt No. R000019167
Scientific Title Detection of biomarkers in the prodromal phase of Parkinson's disease (The Japan Parkinson's Progression Markers Initiative; J-PPMI)
Date of disclosure of the study information 2015/03/16
Last modified on 2015/03/09

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Basic information
Public title Detection of biomarkers in the prodromal phase of Parkinson's disease (The Japan Parkinson's Progression Markers Initiative; J-PPMI)
Acronym Detection of biomarkers in the prodromal phase of Parkinson's disease (The Japan Parkinson's Progression Markers Initiative; J-PPMI)
Scientific Title Detection of biomarkers in the prodromal phase of Parkinson's disease (The Japan Parkinson's Progression Markers Initiative; J-PPMI)
Scientific Title:Acronym Detection of biomarkers in the prodromal phase of Parkinson's disease (The Japan Parkinson's Progression Markers Initiative; J-PPMI)
Region
Japan

Condition
Condition REM sleep behavior disorder
Classification by specialty
Neurology Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Longitudinal, multi-center study to assess the progression of clinical features, imaging and biological markers in the prodromal phase of synucleinopathy in RBD patients.
1. Observe the differences of decrease rate in DAT SPECT uptake (caused by age, sex and the period up to onset).
2. Observe the progression of motor or non-motor symptoms after the uptake decrease in DAT SPECT starts.
3. Observe the differences in the progression of clinical symptoms depending on the reduction of the MIBG uptake in early stage.
4. Observe the neural network changes before and after the onset of motor symptoms by structural and functional MRI (VBM, DTI and rsfMRI).
5. Reveal the predictor of progression to PD, DLB or MSA.
6. Construct the repository containing imaging, biospecimen and clinical information.
Basic objectives2 Others
Basic objectives -Others This study is a natural history study of RBS patients.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To establish the predictive value of early clinical features, baseline imaging (MRI, DAT SPECT and MIBG cardiac scintigraphy) and biomic outcomes for future course of synucleinopathy. Collection and storage of the samples for identification of new biomarkers.
Key secondary outcomes

Base
Study type

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 Prevention
Type of intervention
Other
Interventions/Control_1 DaT SPECT, MIBG cardiac scintigraphy and lumbar tap
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Male or female RBD patients, who are 60 years or older.
2)A clinical diagnosis of RBD as determined by the sleep specialist (Diagnostic criteria is ISCD-3).
3)Ability to provide written informed consent.
4)Willing and able to comply with scheduled visits, required study procedures and laboratory tests.
Decreased DAT SPECT (N=100) and normal DAT SPECT (N=100).
Key exclusion criteria 1)Current or active clinically significant neurological disorder (in the opinion of the Investigator).
2)GDS score greater than or equal to 10 (GDS score of 5-9 requires Investigator discretion to enter study).
3)STAI Form Y-1 greater than or equal to 65 requires Investigator discretion to enter study(STAI Form Y-1 score of 55-64 requires Investigator discretion to enter study).
4)A clinical diagnosis of dementia as determined by the investigator.
5)A clinical diagnosis of Parkinson's disease at the Screening visit as determined by the Investigator.
6)Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
7)Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
8)Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
9)Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
10)Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
11)Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miho Murata
Organization National Center Hospital, National Center of Neurology and Psychiatry
Division name Department of Neurology
Zip code
Address 4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL 042-341-2711
Email mihom@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Sakamoto
Organization National Center Hospital, National Center of Neurology and Psychiatry
Division name Executive office of J-PPMI
Zip code
Address 4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL 042-341-2712-2339
Homepage URL
Email jppmi@ncnp.go.jp

Sponsor
Institute Executive office of J-PPMI,
National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Japanese Government offices
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Neurology, Juntendo University Graduate School of Medicine
Department of Neurology, Kyoto University Graduate School of Medicine
Department of Neurology, Osaka University Graduate School of Medicine
Department of Neurology, Nagoya University Graduate School of Medicine
Brain Research Institute, Niigata University
Name of secondary funder(s) Nihon Medi-Physics Co., Ltd.
FUJIFILM RI Pharma Co., Ltd.

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 国立精神・神経医療研究センター病院(東京都)、順天堂大学医学部附属順天堂医院(東京都)、京都大学医学部附属病院(京都府)、大阪大学医学部附属病院(大阪府)、名古屋大学医学部附属病院(愛知県)
National Center Hospital, Juntendo University Hospital, Kyoto University Hospital, Osana University Hospital, Nagoya University Hospital

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 16 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 Preinitiation
Date of protocol fixation
2015 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 09 Day
Last modified on
2015 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019167

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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