North American Prodromal Synucleinopathy (NAPS) Consortium
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-004722
NCT ID: NCT03623672
Sponsor Protocol Number: R34 AG056639
About this study
The purpose of this study is to establish a registry of RBD patients, develop quantitative biological and functional measures of synucleinopathy burden, and establish a formal process to evaluate candidate neuroprotective agents.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Undergone an overnight polysomnogram that was used to diagnose REM Sleep Behavior Disorder.
- 18 years of age or older.
- Capable of providing informed consent using the current IRB approved consent document.
Exclusion Criteria:
- Known diagnosis of PD, dementia of any type, or MSA,
- RBD associated with narcolepsy or suspected due to another neurological etiology (i.e. non-idiopathic RBD),
- For Lumbar puncture only: Anticoagulant medication or bleeding disorder,
- For Lumbar puncture only: Prior lumbar surgery or procedure that precludes LP.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bradley Boeve, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available