Status:
TERMINATED
A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients With Synucleinopathies
Lead Sponsor:
Stony Brook University
Conditions:
Parkinson Disease
Multiple System Atrophy
Eligibility:
All Genders
50-75 years
Brief 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 Disord...
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 (R...
Eligibility Criteria
Inclusion
- For PD subjects:
- Age 50-75
- Diagnosis of idiopathic PD as confirmed by a movement disorder specialist
- Age of onset of motor symptoms between 50 - 75
- Well-established response to dopaminergic agents and/or amantadine
- Ability to complete questionnaires
- Ability to provide informed consent
- Willingness to go off parkinsonian medication for 12 hours prior to "off" assessment
- Medical record includes a brain MRI taken within the past 12 months showing no evidence of a tumor or abscess
Exclusion
- Symptomatic (secondary) parkinsonism (ie. drug induced)
- Atypical parkinsonian variants
- History of cancer (except basal or squamous cell skin cancer) within 5 years
- Known liver disease
- Hematological disorders
- History of stereotactic or ablative brain surgery
- Treatment with an investigational drug or device within the last 30 days
- Pregnancy
- Inability to comply with or tolerate study procedures
- Conditions precluding the safe performance of lumbar puncture (LP): use of anticoagulants and hematologic abnormalities (INR\>1.3;platelet count \<80,000)
- MSA Subjects:
- Inclusion Criteria:
- Age 50-75
- Age of onset of motor symptoms between 50-75
- Diagnosis of probable or possible MSA as confirmed by a movement disorders specialist
- Ability to complete questionnaires
- Ability to provide informed consent
- Willingness to go off parkinsonian medications for 12 hours prior to "off" assessment
- Medical record indicates a brain MRI taken within the past 12 months showing no evidence of a tumor or abscess
- Exclusion Criteria
- Symptomatic (secondary) parkinsonism (ie. drug induced)
- History of cancer (except basal or squamous cell skin cancer) within 5 years
- Known liver disease
- Hematological disorders
- History of stereotactic or ablative brain surgery
- Treatment with an investigational drug or device within the last 30 days
- Pregnancy
- Inability to comply with or tolerate study procedures
- Conditions precluding the safe performance of lumbar puncture (LP): use of anticoagulants and hematologic abnormalities (INR\>1.3;platelet count \<80,000)
- For RBD Subjects:
- Inclusion Criteria:
- Age 50-75
- Diagnosis of RBD using current consensus criteria
- Ability to provide informed consent
- Ability to complete questionnaires
- Medical record indicates a brain MRI taken within the past 12 months showing no evidence of a tumor or abscess
- Exclusion Criteria
- Signs for symptoms suggestive of parkinsonian disorder
- History of cancer (except basal or squamous cell skin cancer) within 5 years
- Known liver disease
- Hematological disorders
- History of stereotactic or ablative brain surgery
- Treatment with an investigational drug or device within the last 30 days
- Pregnancy
- Inability to comply with or tolerate study procedures
- Conditions precluding the safe performance of lumbar puncture (LP): use of anticoagulants and hematologic abnormalities (INR\>1.3;platelet count \<80,000)
- For NPH:
- Inclusion Criteria:
- Age 50-75
- Scheduled to undergo an LP to evaluate diagnosis of NPH at Stony Brook Neurological Associates
- Ability to complete questionnaires
- Ability to provide informed consent
Key Trial Info
Start Date :
January 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 19 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04020198
Start Date
January 15 2020
End Date
October 19 2022
Last Update
April 6 2025
Active Locations (1)
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1
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-8121