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Neuro-immune Interactome in Parkinson's Disease

NCT07026929 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2025-06-18

No results posted yet for this study

Summary

This study will be observational and have a prospective case-control longitudinal design. Eligible subjects with idiopathic REM behavior disorder (RBD), Parkinson's disease with RBD, and healthy controls will be recruited. Subjects will undergo a sleep study to determine eligibility for the study and then in the study will undergo clinical assessments, including cognitive, sensory and motor clinical assessment, dopamine transporter scanning, and smell testing. Eligible subjects will undergo phlebotomy, lumbar puncture, stool and saliva collection, and genome-wide association scans at baseline and then undergo yearly sensory and motor clinical assessment to assess for phenoconversion to neurodegenerative disease.

From blood and CSF samples, investigators will isolate mononuclear cells, and using cell immunologic and single cell genomic procedures, will look for the presence of T cells which autoreact with alpha-synuclein. Investigators will also look for the presence of increased clonality of T cells reflecting increased immune cell activation and the presence of cross reactivity of anti-alpha-synuclein T cells with microbial agents from subject gut stool samples.

Conditions

  • Parkinson Disease

Sponsors & Collaborators

  • Fox (Michael J.) Foundation for Parkinson's Research

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Principal Investigators

  • Jesse Cedarbaum · Yale University

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2024-06-27
Completion
2031-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07026929 on ClinicalTrials.gov