Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04450992
Study type Observational
Source NYU Langone Health
Contact
Status Active, not recruiting
Phase
Start date June 17, 2020
Completion date July 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT03593512 - Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy N/A
Recruiting NCT03648905 - Clinical Laboratory Evaluation of Chronic Autonomic Failure
Active, not recruiting NCT05699460 - Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
Recruiting NCT02897063 - Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Phase 1
Not yet recruiting NCT00758849 - Fipamezole in Neurogenic Orthostatic Hypotension Phase 2
Completed NCT01155492 - Increased Gut Permeability to Lipopolysaccharides (LPS) in Parkinson's Disease N/A
Recruiting NCT04431713 - Exenatide Once-weekly as a Treatment for Multiple System Atrophy Phase 2
Completed NCT04184063 - Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA) Phase 2
Recruiting NCT05121012 - Synaptic Loss in Multiple System Atrophy
Terminated NCT03589976 - A Futility Trial of Sirolimus in Multiple System Atrophy Phase 2
Recruiting NCT04706234 - Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies
Completed NCT00368199 - Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes N/A
Recruiting NCT04472130 - Neurodegenerative Diseases Registry
Recruiting NCT04876326 - Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy N/A
Recruiting NCT04680065 - GDNF Gene Therapy for Multiple System Atrophy Phase 1
Completed NCT03753763 - Safinamide for Multiple System Atrophy (MSA) Phase 2
Recruiting NCT04250493 - Insulin Resistance in Multiple System Atrophy N/A
Recruiting NCT06072105 - Medical Decision Making in Multiple System Atrophy N/A
Terminated NCT02149901 - Water and Sudafed in Autonomic Failure Early Phase 1
Terminated NCT00997672 - Lithium in Multiple System Atrophy Phase 2