Actively Recruiting

Age: 18Years +
All Genders
ID01799915

Natural History Study of Synucleinopathies

Led by NYU Langone Health · Updated on 2025-06-11

800

Participants Needed

8

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Synucleinopathies are rare neurodegenerative diseases that involve abnormal buildup of the protein alpha-synuclein in the nervous system, often leading to worsening neurological problems. These diseases usually start in late adulthood, typically after age 50, and can cause movement slowing, coordination issues, or mild cognitive problems. Common diagnoses include Parkinson disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). In some cases, symptoms begin with autonomic nerve issues such as unexplained constipation or urinary problems before brain involvement develops. This study aims to understand how these diseases progress and identify biological markers that predict their evolution. The study is observational and follows patients diagnosed with synucleinopathies, including those in the early "pre-motor" stage showing mainly autonomic impairments or REM sleep behavior disorder (RBD). Participants will be monitored over time through a series of follow-up visits at participating centers. The study will document clinical features, track disease markers, and define the natural history of MSA, which is noted as the most aggressive form. Different patient groups include those with RBD, MSA, pure autonomic failure, PD, and DLB. Participants will undergo clinical evaluations to observe symptoms and disease progression. Researchers will collect data on autonomic function and biomarkers to help predict which patients develop motor or cognitive problems. The primary goal is to create a detailed database of autonomic disorders over five years, with a focus on defining disease milestones and identifying predictive biomarkers. This long-term monitoring will help guide future clinical trials and improve understanding of these complex disorders.

CONDITIONS

Brief Title

Natural History Study of Synucleinopathies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Both male and female patients
  • Aged 18 or over
  • Referred to participating sites with orthostatic intolerance symptoms such as dizziness or lightheadedness when standing that improve when lying down
Not Eligible

You will not qualify if you...

  • Diabetes according to American Diabetes Association criteria
  • Congestive heart failure
  • Lupus or other collagen vascular diseases
  • Systemic illnesses causing orthostatic intolerance
  • Drug-induced orthostatic hypotension (due to certain medications like alpha-blockers, diuretics, tricyclic antidepressants)
  • Isolated vasovagal syncope
  • Inability to comply with the study protocol, including uncooperative behavior or inability to attend follow-up visits

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 5 years

Participants are observed over time to understand the natural progression of synucleinopathies and to identify biomarkers predicting disease spread.

Regular follow-up visits over the study period

Trial Site Locations

Total: 8 locations

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Actively Recruiting

2

University of Michigan

Ann Arbor, Michigan, United States

Actively Recruiting

3

Mayo Clinic

Rochester, Minnesota, United States

Actively Recruiting

4

NYU Medical Center

New York, New York, United States, 10016

Actively Recruiting

5

Vanderbilt Univeristy

Nashville, Tennessee, United States

Actively Recruiting

6

FLENI - Fundación para la Lucha contras las Enfermedades Neurológicas

Buenos Aires, Argentina

Actively Recruiting

7

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

8

BioCruces Research Institute - Hospital Universitario de Cruces

Bilbao, Spain

Actively Recruiting

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Research Team

H

Horacio Kaufmann, MD

G

Grace Nkrumah

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Published Research Related To This Trial

Limitations of the Unified Multiple System Atrophy Rating Scale as outcome measure for clinical trials and a roadmap for improvement.

Jose-Alberto Palma, Patricio Millar Vernetti, Miguel A Perez...

https://pubmed.ncbi.nlm.nih.gov/33554315

Orthostatic heart rate changes in patients with autonomic failure caused by neurodegenerative synucleinopathies.

Lucy Norcliffe-Kaufmann, Horacio Kaufmann, Jose-Alberto Palma...

https://pubmed.ncbi.nlm.nih.gov/29405350