Detection of biomarkers in the prodromal phase of Parkinson's disease (The Japan Parkinson's Progression Markers Initiative; J-PPMI)

Not Applicable

• Conditions: REM sleep behavior disorder

• Registration Number: JPRN-UMIN000016755
• Lead Sponsor: Executive office of J-PPMI, National Center Hospital, National Center of Neurology and Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: Interventional,observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.