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In collaboration with approximately 8 centers that specialize in iRBD we will recruit a total of 80 individuals for the study. All subjects will be enrolled into a 2-year longitudinal study where skin biopsies will be performed at 3 sites on each patient at 12-month intervals (baseline, year 1, year 2). Plasma blood collection will be performed at 12-month intervals (baseline, year 1, year 2). Detailed quantified examination, cognitive evaluation, medical history, and questionnaires will be performed at each visit. Additional biomarker, imaging and clinical information (if available) will be obtained for the purpose of determining phenoconversion to clinically apparent synucleinopathy.
Subjects enrolled in the study will have baseline evaluations and follow up visits at 12 and 24 months to define any changes to clinical diagnosis (clinical phenoconversion). Skin biopsies will be repeated at the 12- and 24-month follow up visits to determine the rate of P-SYN accumulation over time and the rates of nerve fiber degeneration within punch skin biopsies.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Syn-One Test | Diagnostic Test | Participating subjects will have three small skin punch biopsies. |
| Measure | Description | Time Frame |
|---|---|---|
| Advance the diagnostic utility of the Syn-One Test | Advance the diagnostic utility of the Syn-One Testâ„¢ by defining the metrics of P-SYN deposition and nerve fiber degeneration that predict phenoconversion in iRBD patients. | 3 years |
| Enhance pathological reading through digital quantitative analysis of the Syn-One Test | Enhance pathological reading through digital quantitative analysis of the Syn-One Testâ„¢ using an AI-augmented detection system. Whole slide imaging with extraction of representative neural structures, target stain detection, segmentation, stain quantification and pattern recognition will be performed using deep learning algorithms. Results will be compared against pathologist readings and actual follow-up data to further refine model accuracy. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with MoCA < 19, Hoehn and Yahr score >/=1, contraindications to skin biopsy
Diagnosis of Parkinson's disease
Diagnosis of dementia of any type
Diagnosis of multiple system atrophy
REM sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and Parkinson's disease)
Contra-indications to skin biopsy:
Gender at birth
80 subjects diagnosed with iRBD
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| Name | Affiliation | Role |
|---|---|---|
| Todd Levine | CND Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD First Research | Chandler | Arizona | 85286 | United States | ||
| Banner Health |
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| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| ID | Term |
|---|---|
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Phoenix |
| Arizona |
| 85006 |
| United States |
| CND Life Sciences | Scottsdale | Arizona | 85258 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Stanford Neuroscience Health Center | Palo Alto | California | 94304 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Mount Sinai | New York | New York | 10003 | United States |
| Texas Institute for Neurological Disorders | Sherman | Texas | 75092 | United States |
| D001523 |
| Mental Disorders |