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A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients With Synucleinopathies | Clinical Trials | Clareo Health

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A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients With Synucleinopathies

NCT04020198•Stony Brook University

View on ClinicalTrials.gov

Summary

This will be an observational study looking at clinical and biomarker characteristics in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Rapid Eye Movement Sleep Behavior Disorder (RBD), Normal Pressure Hydrocephalus and matched controls. Saliva, plasma, serum, urine, and cerebrospinal fluid (CSF) samples will be collected from participants.

Detailed Description

This is an observational study looking at clinical and biomarker characteristics in patients with Parkinson's disease (PD), Multiple System Atrophy (MSA), Rapid Eye Movement Sleep Behavior Disorder (RBD), Normal Pressure Hydrocephalus (NPH) and matched controls. Saliva, plasma, serum, urine, and cerebrospinal fluid samples will be collected from participants. Samples will be assessed for levels of misfolded alpha-synuclein aggregates. Clinical characteristics will also be assessed. Misfolded alpha-synuclein aggregates have the potential to serve as an early biomarker for PD and MSA, increasing the ability to diagnose and treat individuals with these diseases earlier. This study examines the effectiveness of using a novel technique for distinguishing between different parkinsonian disorders by measuring small misfolded α-synuclein aggregates in different biofluids.

Eligibility

Age

50 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•For PD subjects:
•1. Age 50-75
•2. Diagnosis of idiopathic PD as confirmed by a movement disorder specialist
•3. Age of onset of motor symptoms between 50 - 75
•4. Well-established response to dopaminergic agents and/or amantadine
•5. Ability to complete questionnaires
•6. Ability to provide informed consent
•7. Willingness to go off parkinsonian medication for 12 hours prior to "off" assessment
•8. Medical record includes a brain MRI taken within the past 12 months showing no evidence of a tumor or abscess
•1. Age 50-75
+19 more criteria

Exclusion Criteria

•1. Symptomatic (secondary) parkinsonism (ie. drug induced)
•2. Atypical parkinsonian variants
•3. History of cancer (except basal or squamous cell skin cancer) within 5 years
•4. Known liver disease
•5. Hematological disorders
•6. History of stereotactic or ablative brain surgery
•7. Treatment with an investigational drug or device within the last 30 days
•8. Pregnancy
•9. Inability to comply with or tolerate study procedures
•10. Conditions precluding the safe performance of lumbar puncture (LP): use of anticoagulants and hematologic abnormalities (INR\>1.3;platelet count \<80,000)
+40 more criteria

Locations (1)

Stony Brook University Medical Center

Stony Brook, New York, United States

Key Dates

Start Date

January 15, 2020

Primary Completion Date

October 19, 2022

Completion Date

October 19, 2022

Last Updated

April 6, 2025

Enrollment

ACTUAL participants

Conditions

Parkinson DiseaseMultiple System AtrophyRapid Eye Movement Sleep Behavior DisorderNormal Pressure Hydrocephalus

Interventions

Biomarker assay

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients With Synucleinopathies

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

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