Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT06621602
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tissue of the skin that is collected from three locations using a skin punch biopsy.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-09-28', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months', 'timeFrame': '18 months', 'description': 'The accuracy of the pathological test in detecting α-synuclein aggregation and deposition in skin punch biopsies.\n\nMeasurement 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 .'}, {'measure': 'Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months', 'timeFrame': '18 months', 'description': '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 .\n\nTime Frame: 18 months'}, {'measure': 'Changes in phosphorylated alpha-synuclein and clinical assessments from Baseline at 18 months', 'timeFrame': '18 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD', 'RBD'], 'conditions': ['REM Behavior Disorder', 'Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '38506839', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject will be enrolled from approximately 15-20 sites across the US from academic institutions and private clinics.', 'genderDescription': 'sex at birth', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female 50 to 100 years of age\n2. Clinical confirmed diagnosis of Parkinson\\'s disease or REM Sleep Behavior\n\nExclusion Criteria:\n\n1. Clinical evidence of severe vascular disease (history of ulceration, poor wound healing or vascular claudication)\n2. History of allergic reaction to Lidocaine for local anesthesia needed for skin biopsies\n3. Use of blood thinners (Plavix or Aspirin used separately is allowed)\n4. Significantly impaired wound healing or history of scarring or keloid formation'}, 'identificationModule': {'nctId': 'NCT06621602', 'acronym': 'Syn-Q', 'briefTitle': "Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'CND Life Sciences'}, 'officialTitle': "Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'MJFF-025208'}}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Irma Ramos-Ramirez', 'role': 'CONTACT', 'email': 'iramos-ramirez@cndlifesciences.com', 'phone': '480-569-2679'}, {'name': 'Farah Ismail', 'role': 'CONTACT', 'email': 'fismail@cndlifesciences.com', 'phone': '480-434-6382'}, {'name': 'Todd Levine, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CND Life Sciences', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danica Evidente', 'role': 'CONTACT', 'email': 'danica@movementdisorders.us', 'phone': '480-526-5441'}, {'name': 'Virgilio Evidente, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Movement Disorders Center of Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92656', 'city': 'Aliso Viejo', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sujitha Senthil', 'role': 'CONTACT', 'email': 'ssenthil@parkinsonscenter.org', 'phone': '949-738-1613'}, {'name': 'Janne Ho', 'role': 'CONTACT', 'email': 'jho@parkinsonscenter.org', 'phone': '949-712-7498'}, {'name': 'Mindy K Bixby, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Parkinson's Research Centers of America - Orange County", 'geoPoint': {'lat': 33.56504, 'lon': -117.72712}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michele L Gregorio, PhD', 'role': 'CONTACT', 'email': 'michele.gregorio@cshs.org', 'phone': '424-315-0021'}, {'name': 'Michele Tagliati, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars Sinai', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leeana Bade', 'role': 'CONTACT', 'email': 'lbade@parkinsonscenter.org', 'phone': '408-838-5581'}, {'name': 'Salima Brillman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Parkinson's Research Centers of America - Palo Alto", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Neurology Research Partners', 'role': 'CONTACT', 'email': 'Neuroresearch@cuanschutz.edu', 'phone': '303-724-4644'}, {'name': 'Sana Aslam, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emily Forbes, DO', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Flores', 'role': 'CONTACT', 'email': 'jflores@vintrials.com', 'phone': '786-850-2920'}, {'name': 'Jonathan Cross, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aventura Neurologic Associates, LLC', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chelsea English', 'role': 'CONTACT', 'email': 'cenglish@parkinsonscenter.org', 'phone': '561-392-1818'}, {'name': 'Stuart H Isaacson, MD, FAAN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Parkinson's Disease and Movement Disorders Center - Boca Raton", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '30327', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erika Abney, RN, CRC', 'role': 'CONTACT', 'email': 'eabney@atlneuroinstitute.org', 'phone': '404-351-0205', 'phoneExt': '104'}, {'name': 'Yulia Salamatova, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atlanta NeuroScience Institute ANI', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Lee, LPN, MSM', 'role': 'CONTACT', 'email': 'klee9@kumc.edu', 'phone': '913-588-0013'}, {'name': 'Rajesh Pahwa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Parkinson's Disease and Movement Disorders Center at KUMC", 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrea Gambrell, BSN, RN, CCM', 'role': 'CONTACT', 'email': 'andrea.gambrell@nortonhealthcare.org', 'phone': '502-446-8544'}, {'name': 'Jason L Crowell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurology Multidisciplinary Clinic at Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20832', 'city': 'Olney', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yemisrach Tadesse', 'role': 'CONTACT', 'email': 'yemisrach.g.tadesse@medstar.net', 'phone': '301- 570- 8508'}, {'name': 'Osirelis Sanchez', 'role': 'CONTACT', 'email': 'osirelis.sanchez@medstar.net', 'phone': '301-570-7678'}, {'name': 'Patel Sanskruti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anvi Gadani, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'MedStar Montgomery Medical Center', 'geoPoint': {'lat': 39.15316, 'lon': -77.06692}}, {'zip': '02747', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine Lemmertz', 'role': 'CONTACT', 'email': 'klemmertz@bostonneuroresearch.com', 'phone': '508-925-7403'}, {'name': 'Jessica Necchi-Dumas', 'role': 'CONTACT', 'email': 'jdumas@bostonneuroresearch.com', 'phone': '508-925-7403'}, {'name': 'Mushtaque Chachar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boston Neuro Research Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Tropiano', 'role': 'CONTACT', 'email': 'stropiano@parkinsonscenter.org', 'phone': '631-462-7774'}, {'name': 'David L Kreitzman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Parkinson's Research Centers of America - Long Island", 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Jackson, BS', 'role': 'CONTACT', 'email': 'lauren_jackson@urmc.rochester.edu', 'phone': '585-341-7515'}, {'name': 'Frederick Marshall, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Sell, DO', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sandra Wilson', 'role': 'CONTACT', 'email': 'Wilsosan@musc.edu', 'phone': '843-792-4616'}, {'name': 'Lisa Heidelberg', 'role': 'CONTACT', 'email': 'Heidelbe@musc.edu', 'phone': '843-792-4616'}, {'name': 'Christine Cooper, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38157', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Veracity Neuroscience LLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Omalys Biggs Rodriguez, BS', 'role': 'CONTACT', 'email': 'biggsrodrigu@uthscsa.edu', 'phone': '210-450-8456'}, {'name': 'Carolyn Paiz', 'role': 'CONTACT', 'email': 'paizc@uthscsa.edu', 'phone': '210-450-8830'}, {'name': 'Okeanis Eleni Vaou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pablo Coss, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sarah Horn, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Leila Saadatpour, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jessica Grimaldo, PA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sarah Erskine, NP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brian Seegmiller, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UT Health San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Clinical Research', 'role': 'CONTACT', 'email': 'clinicalresearch@cndlifesciences.com', 'phone': '480-569-2902'}], 'overallOfficials': [{'name': 'Todd Levine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CND Life Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CND Life Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': "Michael J. Fox Foundation for Parkinson's Research", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}