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

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Stony Brook University

Status

Terminated

Conditions

Multiple System Atrophy
Parkinson Disease
Normal Pressure Hydrocephalus
Rapid Eye Movement Sleep Behavior Disorder

Treatments

Other: Biomarker assay

Study type

Observational

Funder types

Other

Identifiers

NCT04020198
SNCA 1355881

Details and patient eligibility

About

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.

Full 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.

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Enrollment

8 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

For PD subjects:

Inclusion Criteria:

  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

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)

MSA Subjects:

Inclusion Criteria:

  1. Age 50-75
  2. Age of onset of motor symptoms between 50-75
  3. Diagnosis of probable or possible MSA as confirmed by a movement disorders specialist
  4. Ability to complete questionnaires
  5. Ability to provide informed consent
  6. Willingness to go off parkinsonian medications for 12 hours prior to "off" assessment
  7. Medical record indicates a brain MRI taken within the past 12 months showing no evidence of a tumor or abscess

Exclusion Criteria

  1. Symptomatic (secondary) parkinsonism (ie. drug induced)
  2. History of cancer (except basal or squamous cell skin cancer) within 5 years
  3. Known liver disease
  4. Hematological disorders
  5. History of stereotactic or ablative brain surgery
  6. Treatment with an investigational drug or device within the last 30 days
  7. Pregnancy
  8. Inability to comply with or tolerate study procedures
  9. 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:

  1. Age 50-75
  2. Diagnosis of RBD using current consensus criteria
  3. Ability to provide informed consent
  4. Ability to complete questionnaires
  5. Medical record indicates a brain MRI taken within the past 12 months showing no evidence of a tumor or abscess

Exclusion Criteria

  1. Signs for symptoms suggestive of parkinsonian disorder
  2. History of cancer (except basal or squamous cell skin cancer) within 5 years
  3. Known liver disease
  4. Hematological disorders
  5. History of stereotactic or ablative brain surgery
  6. Treatment with an investigational drug or device within the last 30 days
  7. Pregnancy
  8. Inability to comply with or tolerate study procedures
  9. 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:

  1. Age 50-75
  2. Scheduled to undergo an LP to evaluate diagnosis of NPH at Stony Brook Neurological Associates
  3. Ability to complete questionnaires
  4. Ability to provide informed consent

Exclusion Criteria:

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

For Controls:

Inclusion Criteria:

  1. Age 50-75
  2. Scheduled to undergo an LP at Stony Brook Neurological Associates
  3. Ability to complete questionnaires
  4. Ability to provide informed consent

Exclusion Criteria:

  1. Signs or symptoms suggestive of parkinsonian disorder
  2. History of rapid eye movement (REM) Sleep Behavior Disorder (RBD)
  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)

Trial design

8 participants in 5 patient groups

Parkinson's Disease
Description:
Subjects who have a PD diagnosis
Treatment:
Other: Biomarker assay
Multiple System Atrophy
Description:
Subjects who have an MSA diagnosis
Treatment:
Other: Biomarker assay
Age-matched controls
Description:
Subjects who do not have a diagnosed parkinsonian disorder
Treatment:
Other: Biomarker assay
Rapid Eye Movement Sleep Behavior Disorder (RBD)
Description:
Subjects who have a diagnosis of RBD
Treatment:
Other: Biomarker assay
Normal Pressure Hydrocephalus
Description:
Subjects who are prescribed a lumbar puncture to treat normal pressure hydrocephalus
Treatment:
Other: Biomarker assay

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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