Observing the progression of synucleinopathies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on the natural history of synucleinopathies, a group of neurodegenerative diseases characterized by the abnormal accumulation of the protein α-synuclein. It aims to track the clinical progression of these conditions, which can begin with autonomic dysfunction and later develop into more severe neurological deficits. Patients aged 18 and older with symptoms of orthostatic intolerance will be monitored across multiple participating sites to gather data on their symptoms and disease progression. The study seeks to enhance understanding of how these diseases manifest and evolve over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Both male and female patients will be included
2. Aged 18 or over
3. Referred to any of the participating consortium sites with orthostatic intolerance, defined as symptoms of dizziness or lightheadedness in the standing position that disappear when supine.

Exclusion Criteria:

1. Diabetes according to the American Diabetes Association criteria
2. Congestive heart failure
3. Lupus or other collagen vascular disease
4. Systemic illness thought to be responsible for the orthostatic intolerance
5. Drug-induced orthostatic hypotension (i.e., the use of alpha-blockers, diuretics, tricyclic antidepressants or others thought by the investigator to play an important role in the patient's orthostatic hypotension)
6. Isolated vasovagal syncope
7. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.

Where it's running

• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• NYU Medical Center
  New York, New York, United States Recruiting
• Vanderbilt Univeristy
  Nashville, Tennessee, United States Recruiting
• FLENI - Fundación para la Lucha contras las Enfermedades Neurológicas
  Buenos Aires, Argentina Recruiting

Study contacts

• Principal investigator: Horacio C Kaufmann, MD — NYU Medical Center
• Study coordinator: Horacio Kaufmann, MD
• Email: horacio.kaufmann@nyulangone.org
• Phone: 212-263-7225

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.