Christopher H Gibbons, Douglas Galasko, Daniel Press, Daniel Claassen, Todd Levine, Roy Freeman
{"title":"Syn-D研究：轻度认知障碍患者皮肤磷酸化α -突触核蛋白检测试验方案。","authors":"Christopher H Gibbons, Douglas Galasko, Daniel Press, Daniel Claassen, Todd Levine, Roy Freeman","doi":"10.1080/17520363.2025.2520154","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Skin biopsies have >95% sensitivity and specificity to detect the presence of phosphorylated alpha-synuclein (P-SYN).</p><p><strong>Objective: </strong>To determine the frequency of cutaneous P-SYN in patients with mild cognitive impairment (MCI) due to suspected Alzheimer's disease (AD) and dementia with Lewy bodies (DLB).</p><p><strong>Design, setting and participants: </strong>The Syn-D study is a multicenter prospective clinical trial from ~10 centers across the United States that includes patients with MCI-AD or MCI-DLB.</p><p><strong>Methods: </strong>Patients will undergo skin biopsies for detection of P-SYN and plasma biomarkers for ptau-217 to determine biomarker positivity rates at the MCI stage and will be followed longitudinally to determine final clinical diagnosis as defined by an expert panel of clinicians blinded to biomarker results.</p><p><strong>Main outcomes and measures: </strong>The co-primary outcomes include: 1) The sensitivity of skin biopsy detection of P-SYN in patients with clinical diagnoses of MCI due to DLB or AD at baseline and at 12-month follow-up 2) To report the frequency with which cutaneous deposition of P-SYN and blood-based AD biomarkers co-exist in a population of patients with MCI.</p><p><strong>Discussion: </strong>This will be the first <i>in-vivo</i> study to determine the co-existence of biomarkers for both diseases as a surrogate for co-pathology.</p><p><strong>Trial registration: </strong>NCT05479552.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"1-8"},"PeriodicalIF":1.9000,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Syn-D study: detection of cutaneous phosphorylated alpha-synuclein in mild cognitive impairment a trial protocol.\",\"authors\":\"Christopher H Gibbons, Douglas Galasko, Daniel Press, Daniel Claassen, Todd Levine, Roy Freeman\",\"doi\":\"10.1080/17520363.2025.2520154\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Skin biopsies have >95% sensitivity and specificity to detect the presence of phosphorylated alpha-synuclein (P-SYN).</p><p><strong>Objective: </strong>To determine the frequency of cutaneous P-SYN in patients with mild cognitive impairment (MCI) due to suspected Alzheimer's disease (AD) and dementia with Lewy bodies (DLB).</p><p><strong>Design, setting and participants: </strong>The Syn-D study is a multicenter prospective clinical trial from ~10 centers across the United States that includes patients with MCI-AD or MCI-DLB.</p><p><strong>Methods: </strong>Patients will undergo skin biopsies for detection of P-SYN and plasma biomarkers for ptau-217 to determine biomarker positivity rates at the MCI stage and will be followed longitudinally to determine final clinical diagnosis as defined by an expert panel of clinicians blinded to biomarker results.</p><p><strong>Main outcomes and measures: </strong>The co-primary outcomes include: 1) The sensitivity of skin biopsy detection of P-SYN in patients with clinical diagnoses of MCI due to DLB or AD at baseline and at 12-month follow-up 2) To report the frequency with which cutaneous deposition of P-SYN and blood-based AD biomarkers co-exist in a population of patients with MCI.</p><p><strong>Discussion: </strong>This will be the first <i>in-vivo</i> study to determine the co-existence of biomarkers for both diseases as a surrogate for co-pathology.</p><p><strong>Trial registration: </strong>NCT05479552.</p>\",\"PeriodicalId\":9182,\"journal\":{\"name\":\"Biomarkers in medicine\",\"volume\":\" \",\"pages\":\"1-8\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-06-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biomarkers in medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/17520363.2025.2520154\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biomarkers in medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17520363.2025.2520154","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
The Syn-D study: detection of cutaneous phosphorylated alpha-synuclein in mild cognitive impairment a trial protocol.
Background: Skin biopsies have >95% sensitivity and specificity to detect the presence of phosphorylated alpha-synuclein (P-SYN).
Objective: To determine the frequency of cutaneous P-SYN in patients with mild cognitive impairment (MCI) due to suspected Alzheimer's disease (AD) and dementia with Lewy bodies (DLB).
Design, setting and participants: The Syn-D study is a multicenter prospective clinical trial from ~10 centers across the United States that includes patients with MCI-AD or MCI-DLB.
Methods: Patients will undergo skin biopsies for detection of P-SYN and plasma biomarkers for ptau-217 to determine biomarker positivity rates at the MCI stage and will be followed longitudinally to determine final clinical diagnosis as defined by an expert panel of clinicians blinded to biomarker results.
Main outcomes and measures: The co-primary outcomes include: 1) The sensitivity of skin biopsy detection of P-SYN in patients with clinical diagnoses of MCI due to DLB or AD at baseline and at 12-month follow-up 2) To report the frequency with which cutaneous deposition of P-SYN and blood-based AD biomarkers co-exist in a population of patients with MCI.
Discussion: This will be the first in-vivo study to determine the co-existence of biomarkers for both diseases as a surrogate for co-pathology.
期刊介绍：
Biomarkers are physical, functional or biochemical indicators of physiological or disease processes. These key indicators can provide vital information in determining disease prognosis, in predicting of response to therapies, adverse events and drug interactions, and in establishing baseline risk. The explosion of interest in biomarker research is driving the development of new predictive, diagnostic and prognostic products in modern medical practice, and biomarkers are also playing an increasingly important role in the discovery and development of new drugs. For the full utility of biomarkers to be realized, we require greater understanding of disease mechanisms, and the interplay between disease mechanisms, therapeutic interventions and the proposed biomarkers. However, in attempting to evaluate the pros and cons of biomarkers systematically, we are moving into new, challenging territory.
Biomarkers in Medicine (ISSN 1752-0363) is a peer-reviewed, rapid publication journal delivering commentary and analysis on the advances in our understanding of biomarkers and their potential and actual applications in medicine. The journal facilitates translation of our research knowledge into the clinic to increase the effectiveness of medical practice.
As the scientific rationale and regulatory acceptance for biomarkers in medicine and in drug development become more fully established, Biomarkers in Medicine provides the platform for all players in this increasingly vital area to communicate and debate all issues relating to the potential utility and applications.
Each issue includes a diversity of content to provide rounded coverage for the research professional. Articles include Guest Editorials, Interviews, Reviews, Research Articles, Perspectives, Priority Paper Evaluations, Special Reports, Case Reports, Conference Reports and Company Profiles. Review coverage is divided into themed sections according to area of therapeutic utility with some issues including themed sections on an area of topical interest.
Biomarkers in Medicine provides a platform for commentary and debate for all professionals with an interest in the identification of biomarkers, elucidation of their role and formalization and approval of their application in modern medicine. The audience for Biomarkers in Medicine includes academic and industrial researchers, clinicians, pathologists, clinical chemists and regulatory professionals.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
