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

Executive office of J-PPMI, National Center Hospital, National Center of Neurology and Psychiatry0 sites200 target enrollmentMarch 16, 2015

ConditionsREM sleep behavior disorder

Overview

Phase: 未知
Intervention: Not specified
Conditions: REM sleep behavior disorder
Sponsor: Executive office of J-PPMI, National Center Hospital, National Center of Neurology and Psychiatry
Enrollment: 200
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 16, 2015

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional,observational

Sex

All

Investigators

Sponsor

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

Eligibility Criteria

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).