REM sleep behavior disorder
Conditions
Interventions
DaT SPECT, MIBG cardiac scintigraphy and lumbar tap
Sponsors
Executive office of J-PPMI, National Center Hospital, National Center of Neurology and Psychiatry
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
Eligibility
Sex/Gender
All
Inclusion criteria
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).
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTakashi Sakamoto
National Center Hospital, National Center of Neurology and Psychiatry Executive office of J-PPMI
Outcome results
None listed