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NCT07026929

Neuro-immune Interactome in Parkinson's Disease

Sponsor: Yale University

View on ClinicalTrials.gov

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.

Official title: Tracing the Origin and Progression of Parkinson's Disease Through the Neuro-Immune Interactome

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

94

Start Date

2021-05-10

Completion Date

2031-06

Last Updated

2025-06-18

Healthy Volunteers

Yes

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States