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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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This study aims to assess the levels of phosphorylated alpha-synuclein (P-SYN) in patients with Parkinson's disease and REM Behavior Disorder using a minimally invasive skin punch biopsy. It seeks to understand the natural progression of P-SYN deposition over time to explore the potential of P-SYN quantification as a biomarker for disease progression.
This is a prospective, longitudinal study involving 75 Parkinson's disease patients and 25 patients with REM Behavior Disorder. Each participant will undergo a baseline evaluation followed by follow-ups every six months over an 18-month period. The evaluations will include clinical assessments, neurologic exams, and skin biopsies from three locations. Data will be collected on disease progression and the amount of P-SYN in cutaneous nerve fibers.
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months | The accuracy of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time . | 18 months |
| Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months | The precision of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time . Time Frame: 18 months | 18 months |
| Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months | The sensitivity of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies. Measurement of the quantity of phosphorylated alpha-synuclein (P-SYN) in each biopsy to determine whether cutaneous biopsies can serve as a biomarker for changes in P-SYN deposition over time . Time Frame: 18 months Time Frame: 18 months | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
sex at birth
Subjects will be enrolled from 18 sites across the US from academic institutions and private clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Todd Levine | CND Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CND Life Sciences | Scottsdale | Arizona | 85258 | United States | ||
| Movement Disorders Center of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38506839 | Result | Gibbons CH, Levine T, Adler C, Bellaire B, Wang N, Stohl J, Agarwal P, Aldridge GM, Barboi A, Evidente VGH, Galasko D, Geschwind MD, Gonzalez-Duarte A, Gil R, Gudesblatt M, Isaacson SH, Kaufmann H, Khemani P, Kumar R, Lamotte G, Liu AJ, McFarland NR, Miglis M, Reynolds A, Sahagian GA, Saint-Hillaire MH, Schwartzbard JB, Singer W, Soileau MJ, Vernino S, Yerstein O, Freeman R. Skin Biopsy Detection of Phosphorylated alpha-Synuclein in Patients With Synucleinopathies. JAMA. 2024 Apr 16;331(15):1298-1306. doi: 10.1001/jama.2024.0792. | |
| 42057930 |
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Tissue of the skin that is collected from three locations using a skin punch biopsy.
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Parkinson's Research Centers of America - Orange County | Aliso Viejo | California | 92656 | United States |
| Cedars Sinai | Los Angeles | California | 90048 | United States |
| Parkinson's Research Centers of America - Palo Alto | Palo Alto | California | 94301 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Aventura Neurologic Associates, LLC | Aventura | Florida | 33180 | United States |
| Parkinson's Disease and Movement Disorders Center - Boca Raton | Boca Raton | Florida | 33486 | United States |
| Atlanta NeuroScience Institute ANI | Atlanta | Georgia | 30327 | United States |
| Parkinson's Disease and Movement Disorders Center at KUMC | Kansas City | Kansas | 66160 | United States |
| Neurology Multidisciplinary Clinic at Norton Healthcare | Louisville | Kentucky | 40241 | United States |
| MedStar Montgomery Medical Center | Olney | Maryland | 20832 | United States |
| Boston Neuro Research Center | Boston | Massachusetts | 02747 | United States |
| Parkinson's Research Centers of America - Long Island | Commack | New York | 11725 | United States |
| University of Rochester | Rochester | New York | 14618 | United States |
| The Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
| Veracity Neuroscience LLC | Memphis | Tennessee | 38157 | United States |
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
| Derived |
| Parent JH, Levine T, Freeman R, Gibbons CH. The Syn-Q study: detection of cutaneous phosphorylated alpha-synuclein in Parkinson's disease progression: a trial protocol. Front Neurol. 2026 Apr 14;17:1823991. doi: 10.3389/fneur.2026.1823991. eCollection 2026. |
| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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