Observing the progression of synucleinopathies

Natural History Study of Synucleinopathies

This study is tracking how synucleinopathies, a group of brain diseases, progress in adults with symptoms like dizziness when standing up to better understand their development over time.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 8 sites (Boston, Massachusetts and 7 other locations)
• Trial ID: NCT01799915 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older experiencing symptoms of orthostatic intolerance.

Not a fit: Patients with conditions such as diabetes, congestive heart failure, or other systemic illnesses causing orthostatic intolerance may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and management strategies for patients with synucleinopathies.

How similar studies have performed: While the study's approach is observational and builds on existing knowledge, similar studies have provided valuable insights into the progression of neurodegenerative diseases.

Eligibility criteria

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 this trial is running

Boston, Massachusetts and 7 other locations

• 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)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• BioCruces Research Institute - Hospital Universitario de Cruces — Bilbao, Spain (Recruiting)

Study contacts

• Principal investigator: Horacio C Kaufmann, MD — NYU Medical Center
• Study coordinator: Horacio Kaufmann, MD

Conditions Patients With Synucleinopathies; Neurogenic Orthostatic Hypotension; Pure Autonomic Failure; REM Sleep Behavior Disorder; Parkinson Disease; Dementia With Lewy Bodies; Multiple System Atrophy; Shy-Drager Disease