UMIN-CTR Clinical Trial

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

REM sleep behavior disorder

Classification by specialty

Neurology

Psychiatry

Classification by malignancy

Others

Genomic information

YES

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

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

Study type

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Japanese Government offices

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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.

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2015

Year

03

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

03

Month

09

Day

Last modified on

2015

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019167