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The Synuclein-One Study will be evaluating α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.
Phosphorylated α-synuclein pathology in the diagnosis of synucleinopathies through qualitative and quantitative measurements of cutaneous phosphorylated α-synuclein in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. An effective tissue biomarker will provide an accurate diagnosis of α-synuclein in clinical practice, will differentiate between synucleinopathies, enable assessment of target engagement in the development of disease modifying and neuroprotective therapies and accelerate the development of neuroprotective and disease modifying therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's disease | Looking for 105 patients with a clinically established diagnosis of Parkinson's disease between 40-99 years of age. |
| |
| Multiple System Atrophy | Looking for 40 patients with a clinically established diagnosis of Multiple System Atrophy between 40-99 years of age. |
| |
| Dementia with Lewy bodies | Looking for 95 patients with a clinically established diagnosis of Dementia with Lewy bodies between 40-99 years of age. |
| |
| Pure Autonomic Failure | Looking for 60 patients with a clinically established diagnosis of Pure Autonomic Failure between 40-99 years of age. |
| |
| Healthy Controls | No history of clinical or symptoms suggestive of Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies or Pure Autonomic Failure between 40-99 years of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Biopsy | Diagnostic Test | Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome 1 | To define test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein. | 2 years |
| Primary Outcome 2 | To define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein. | 2 years |
| Primary Outcome 3 | To differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible men and women, age 40-99 years, will undergo a screening evaluation that includes a thorough medical history, physical and neurologic exam, orthostatic vitals, questionnaires and skin biopsy completed in one visit.
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| Name | Affiliation | Role |
|---|---|---|
| Todd Levine, MD | CND Life Sciences: www.cndlifesciences.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD First Research | Chandler | Arizona | 85286 | United States | ||
| CND Life Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41449577 | Derived | Gibbons CH, Levine T, Adler CH, Bellaire B, Wang N, Agarwal P, Aldridge GM, Barboi A, Claassen D, Evidente VGH, Galasko D, Gonzalez-Duarte A, Gil R, Gudesblatt M, Isaacson SH, Kaufmann H, Khemani P, Kumar R, Lamotte G, Liu AJ, McFarland NR, Miglis MG, Reynolds A, Sahagian GA, Saint-Hilaire MH, Schwartzbard JB, Singer W, Soileau MJ, Vernino S, Millar Vernetti P, Yerstein O, Freeman R. Cutaneous Phosphorylated Alpha-Synuclein in Lewy Body Dementia. Ann Clin Transl Neurol. 2026 May;13(5):1041-1051. doi: 10.1002/acn3.70291. Epub 2025 Dec 25. | |
| 35272481 |
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IPD will be shared with researchers that are involved in the study.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 22, 2024 | |
| Reset | Sep 26, 2024 |
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Skin Biopsy
|
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Movement Disorders Center of Arizona | Scottsdale | Arizona | 85258 | United States |
| The Neuro Center | Carlsbad | California | 92011 | United States |
| Providence St. John's Health | Santa Monica | California | 90404 | United States |
| Rocky Mountain Movement Disorders Center, PC | Englewood | Colorado | 80113 | United States |
| Aventura Neurology | Aventura | Florida | 33180 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| UF College of Medicine | Gainesville | Florida | 32608 | United States |
| Parkinson's Disease Treatment Center SWFL | Port Charlotte | Florida | 33980 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Beth Israel Lahey Health | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| NYU Medical Center | New York | New York | 10016 | United States |
| SouthShore Neurologic | Patchogue | New York | 11772 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Providence Brain & Spine Institute | Portland | Oregon | 97225 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| UTSouthwestern | Dallas | Texas | 75390 | United States |
| Texas Movement Disorders Specialists | Georgetown | Texas | 78628 | United States |
| Evergreen Health | Kirkland | Washington | 98034 | United States |
| Swedish Neuroscience Research | Seattle | Washington | 98122 | United States |
| Derived |
| Gibbons CH, Freeman R, Bellaire B, Adler CH, Moore D, Levine T. Synuclein-One study: skin biopsy detection of phosphorylated alpha-synuclein for diagnosis of synucleinopathies. Biomark Med. 2022 May;16(7):499-509. doi: 10.2217/bmm-2021-0646. Epub 2022 Mar 11. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2024 | Sep 26, 2024 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D019578 | Multiple System Atrophy |
| D020961 | Lewy Body Disease |
| D054970 | Pure Autonomic Failure |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D003704 | Dementia |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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