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

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    NYU Langone Health
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Updated on 19 February 2024
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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.

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.

Details
Condition Multiple System Atrophy, Shy-Drager Syndrome
Age 40-80 years
Clinical Study IdentifierNCT04450992
SponsorNYU Langone Health
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

\. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable privacy regulations 2. Diagnosis of probable or possible multiple system atrophy (MSA-P or MSA-C) according to current consensus diagnostic criteria [8]. 3\. Aged 40-80 with anticipated survival of at least 3 years (in the opinion of the Investigator) 4. Able to walk for, at least, 10 meters with or without assistance 5. Willingness and ability to participate in all study procedures. 6. Ability to tolerate and no contraindications for brain MRI. 7. Ability to tolerate and no contraindications for CSF collection. Participants with contraindication to the CSF procedure will be given the option to participate in the study and opt out the CSF collection. An effort will be made to ensure that at least 50% of patients enrolled in the study undergo CSF collection

Exclusion Criteria

\. Presence of supranuclear gaze palsy. 2. Known presence of hyposmia (i.e., reduced ability to smell and detect odors). 3\. Presence of cognitive dysfunction (defined as MoCA score <20). 4. Severe-to-complete dependence on caregivers (score >3 on UMSARS Part IV, Global Disability), severe impairment of swallowing (score 3 on UMSARS Part I, Question 2), or frequent falls (score 3 on UMSARS Part I, Question 8) at Baseline. 5\. Family history or a known genetic cause of ataxia or parkinsonism. 6. Clinically significant neuropathy. 7. Hallucinations not induced by drugs. 8. Unstable psychiatric illness, including psychosis, suicidal ideation, or untreated major depression within 90 days before Baseline, as determined by the Investigator. 9\. History or Baseline MRI results showing evidence of structural abnormalities that could contribute to the participant's clinical state other than findings typical of MSA, or any finding that might pose a risk to the participant. 10\. Any contraindications to having a brain MRI (e.g., pacemaker; MRI-incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed without requiring general anesthesia, etc.). 11\. Transient ischemic attack or stroke, or any unexplained loss of consciousness within 1 year before Baseline. 12\. History of any brain surgery for MSA (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplant) or a history of focused ultrasound treatment or neuromodulation procedures, including but not limited to transcranial magnetic stimulation (TMS) and transcranial direct or alternating current stimulation (tDCS/tACS) that have been performed within 90 days of Baseline
Infection Risk 13. History of human immunodeficiency virus or hepatitis C
virus antibody. 14\. Chronic, recurrent, or serious infection (e.g
pneumonia, septicemia, recurrent urinary tract infection), as determined by
the Investigator, within 8 weeks before Day 1
Cardiovascular 15. History of unstable angina, myocardial infarction, chronic
heart failure (New York Heart Association Class 3 or 4), or clinically
significant conduction abnormalities (e.g., unstable atrial fibrillation)
within 1 year before Baseline
\. Chronic, sustained, uncontrolled supine hypertension (unrelated to
pharmacological treatment of orthostatic hypotension) defined by an average of
three SBP readings of >180 mmHg or DBP readings of >110 mmHg at baseline
\. In participants treated pharmacologically for orthostatic hypotension
any documented sitting or standing SBP reading 180 mmHg or DBP reading 110
mmHg within the 3 months before Day 1 or on Day 1)
\. Severe orthostatic hypotension despite optimal medical management
(defined as a score of 3 on UMSARS Part I, Question 9)
Oncology 19. History of, or ongoing, malignant disease, including solid tumors
and hematologic malignancies (with the exception of basal cell carcinomas and
squamous cell carcinomas that have been completely excised and considered
cured at least 12 months prior to Day -1). Participants with cancers in
remission for greater than 5 years prior to Day -1 may be included
Metabolic 20. Poorly controlled diabetes mellitus, as defined by having dosage
adjustment of diabetic medication within 3 months before dosing (Day 1) or
glycated hemoglobin value 8% at Baseline
Hypersensitivity 21. Clinically significant allergies, as determined by the
Investigator, to anesthetics that will be used for the LP per institutional
practice, or iodine
Other Medical History or Health Status 22. History of any clinically
significant endocrinologic, hematologic, hepatic, immunologic, metabolic
urologic, pulmonary, neurologic, dermatologic, renal ischemic, or other major
diseases, as determined by the Investigator
\. Surgery within 12 weeks before Day 1 (other than minor cosmetic surgery
and minor dental surgery, as determined by the Investigator)
Any contraindications to LP procedures, including but not limited to
\. Known or suspected structural abnormality of the lumbar spine, including
but not limited to X-ray, MRI, or myelographic evidence of significant lumbar
spine abnormalities, or other anatomical factors at or near the LP site that
in the opinion of the Investigator, may interfere with the performance of the
LP, render repeated LPs difficult, or increase the risk of the procedure for
the participant
\. Presence of risk for increased or uncontrolled bleeding and/or risk of
bleeding that is not managed optimally and might place a participant at an
increased risk for intraoperative or postoperative bleeding. These could
include, but are not limited to, anatomical factors at or near the LP site
(e.g., vascular abnormalities, neoplasms, or other abnormalities), known
underlying disorders of the coagulation cascade, platelet function, or
platelet count (e.g., hemophilia, von Willebrand's disease, liver disease)
\. Unwillingness or inability to comply with the requirements of this
protocol
\. Other unspecified reasons that, in the opinion of the Investigator, make
the participant unsuitable for enrollment
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