Natural History Study of Synucleinopathies

Biomarkers and Brain Imaging Related Dementias

Overall Status

Recruiting

Brief Description

In this observational study, researchers will document the clinical features and biological markers of people with synucleinopathies (Parkinson's disease, dementia with Lewy bodies, or multiple system atrophy) and those in a pre-dementia stage to better understand how these disorders evolve over time.

Patient Qualifications

Minimum Age	Maximum Age	Gender	Healthy Volunteers
18 Years	N/A	All	No

Study Start Date:

June 2011

Study End Date:

July 2020

Enrollment:

800

Inclusion Criteria

Referred to any study site with orthostatic intolerance (dizziness or lightheadedness when standing that disappears when lying face upward)

Exclusion Criteria

Diabetes
Congestive heart failure
Lupus or other collagen vascular disease
Systemic illness thought to be responsible for orthostatic intolerance
Drug-induced orthostatic hypotension (e.g., the use of alpha-blockers, diuretics, and/or tricyclic antidepressants)
Isolated vasovagal syncope (fainting as a result of a sudden drop in blood pressure and heart rate)

Detailed Description

Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and abnormal accumulation of the protein alpha-synuclein in the nervous system. Researchers will follow people diagnosed with a synucleinopathy and those believed to be in a pre-dementia stage over a 5-year period. The study aims to find biological clues of disease progression that would allow for testing of disease-modifying strategies to delay or stop the neurodegenerative process.

Locations

Name	City	State	Zip	Status	Primary Contact
Beth Israel Deaconess Medical Center	Boston	Massachusetts		Recruiting	Sharika Rajan 617-632-0864 srajan@bidmc.harvard.edu
University of Michigan	Ann Arbor	Michigan		Recruiting	Arijit Bhaumik, BA 734-936-8281 arijit@umich.edu
Mayo Clinic	Rochester	Minnesota		Recruiting	Tonette Gehrking 507-284-0336 adc.research@mayo.edu
NYU Medical Center	New York	New York	10016	Recruiting	Jose Martinez, MA 212-263-7225 jose.martinez@nyumc.org
Vanderbilt Univeristy	Nashville	Tennessee		Recruiting	Emily Garland, PhD 615-936-1748 emily.garland@Vanderbilt.Edu

Lead Sponsor Agency

Investigators

Name	Role	Affiliation
Horacio C. Kaufmann, MD	Principal Investigator	NYU Medical Center

ClinicalTrials.gov ID: NCT01799915

Official Title: Natural History Study of Synucleinopathies