NCT04450992

TRACK-MSA: A Longitudinal Study to Define Outcome Measures in Multiple System Atrophy

TRACK-MSA: An Observational Longitudinal Oligo-Center Study to Define Clinical, Biofluid, Imaging and Digital Outcome Measures in Multiple System Atrophy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: —

Summary

TRACK-MSA is an observational, non-interventional, longitudinal natural history study to define changes in clinical, neurological, blood, CSF, and neuroimaging biomarkers in patients with multiple system atrophy (MSA) comparing baseline to 6-month and 1-year assessments. The study will enroll 50 patients with MSA-P or MSA-C at 2 or more participating sites.

Detailed description

TRACK-MSA is designed to relate phenotypic characteristics of participants with MSA using several modalities (i.e., clinical, quantitative motor, imaging, laboratory) in order to relate phenotypic characteristics with data derived from the study of blood and CSF ("wet biomarkers") and imaging or wearables ("dry biomarkers"). It is possible that the cohort enrolled in this study will, after study completion, be recruited into the earliest multicenter biomarker-driven clinical trials of disease modifying agents for MSA. As such, the data collected in the TRACK-MSA study could constitute a valuable observational non-interventional arm of potential disease-modifying treatments. The objective of the study will therefore be to determine the combination of measures that most sensitively detects changes over the natural course of MSA, with a goal of validating these measures for use in future clinical trials. TRACK-MSA will be a 1-year observational, longitudinal, non-interventional natural history study of patients with MSA. The study will be carried out at least at 2 sites (NYU being the primary site). All participants will be assessed at baseline, 6-month and 1-year visits. Participants will undergo clinical, neurological, quantitative motor, MRI assessments, in addition to donating blood and CSF samples at some or all of the visits. For a given participant, the same investigator should carry out the clinical assessment throughout the study where possible. It is anticipated that the study will complete enrollment in 2 years since startup, and complete all the follow-up evaluations within 3 years from startup.

Conditions

• Multiple System Atrophy

Timeline

• Start date: 2020-06-17
• Primary completion: 2024-06-19
• Completion: 2024-06-19
• First posted: 2020-06-30
• Last updated: 2024-07-31

Locations

1 site across 1 country: United States