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The purpose of this study is to learn about the character and course of rapid eye movement (REM) sleep behavior disorder (RBD) and REM sleep without atonia (RSWA).
In this study we hope to monitor you over a period of three years to observe any long-term changes in your clinical symptoms and to determine if they indicate the development of a neurodegenerative disorder, such as Parkinson’s disease.
The relationship between these disorders and RBD/RSWA is not well understood, beyond the occurrence of RBD/RSWA in patients with Parkinson’s disease. There is no current tool or method to predict whether people with these sleep disorders will develop a neurodegenerative disorder, and through this study we hope to find indicators that can be used to recognize and predict the risk of development.
In this study we will observe certain clinical and laboratory characteristics of patients with RBD or RSWA over a three-year period. We anticipate this will provide data to aid in developing tools that will accurately predict the likelihood of development of Parkinson’s disease in similar patients.
Inclusion Criteria:
- Diagnosis of RBD and/or a diagnosis of RSWA confirmed by polysomnography
- Aged 21 years and older at time of enrollment
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
- Willing and able to comply with scheduled visits, required study procedures including MRI, and laboratory tests.
Exclusion Criteria:
- Diagnosis of a neurodegenerative disorder, including: Parkinson’s disease, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, Alzheimer’s disease, frontotemporal dementia, dementia with Lewy bodies, and other rare neurodegenerative disorders.
- Other serious neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, encephalitis, clinically significant sequelae of head trauma).
- Diagnosis of congestive heart failure, clinically significant cardiac arrhythmia
- Active cancer or a history of cancer within the last 1 year (excluding squamous and basal cell skin cancers),
- Diagnosis of uncontrolled diabetes; uncontrolled thyroid disease; an autoimmune disorder active or within the last 5 years
- Presence of liver disease or renal failure
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
- Use of investigational drugs or devices within 60 days prior to baseline.
- Diagnosis of supra-nuclear gaze palsy, cerebellar abnormalities, or corticospinal tract signs.
- History of brain surgery including pallidotomy, thalamotomy, subthalamotomy or deep brain stimulator (DBS) implantation.
Upper East Side - Manhattan
Open to Enrollment
