Condition or disease | Intervention/treatment |
---|---|
Parkinson Disease Multiple System Atrophy Rapid Eye Movement Sleep Behavior Disorder Normal Pressure Hydrocephalus | Other: Biomarker assay |
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.
Study Type : | Observational |
Estimated Enrollment : | 24 participants |
Observational Model: | Other |
Time Perspective: | Other |
Official Title: | A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients With Synucleinopathies |
Actual Study Start Date : | January 15, 2020 |
Estimated Primary Completion Date : | February 1, 2022 |
Estimated Study Completion Date : | June 1, 2022 |
Group/Cohort | Intervention/treatment |
---|---|
Parkinson's Disease
Subjects who have a PD diagnosis
|
Other: Biomarker assay
Biomarker assay will be used to quantify levels of misfolded alpha-synuclein aggregates in biofluid samples from patients with Parkinson's disease, multiple system atrophy, rapid eye movement sleep behavior disorder, normal pressure hydrocephalus and controls.
|
Multiple System Atrophy
Subjects who have an MSA diagnosis
|
Other: Biomarker assay
Biomarker assay will be used to quantify levels of misfolded alpha-synuclein aggregates in biofluid samples from patients with Parkinson's disease, multiple system atrophy, rapid eye movement sleep behavior disorder, normal pressure hydrocephalus and controls.
|
Age-matched controls
Subjects who do not have a diagnosed parkinsonian disorder
|
Other: Biomarker assay
Biomarker assay will be used to quantify levels of misfolded alpha-synuclein aggregates in biofluid samples from patients with Parkinson's disease, multiple system atrophy, rapid eye movement sleep behavior disorder, normal pressure hydrocephalus and controls.
|
Rapid Eye Movement Sleep Behavior Disorder (RBD)
Subjects who have a diagnosis of RBD
|
Other: Biomarker assay
Biomarker assay will be used to quantify levels of misfolded alpha-synuclein aggregates in biofluid samples from patients with Parkinson's disease, multiple system atrophy, rapid eye movement sleep behavior disorder, normal pressure hydrocephalus and controls.
|
Normal Pressure Hydrocephalus
Subjects who are prescribed a lumbar puncture to treat normal pressure hydrocephalus
|
Other: Biomarker assay
Biomarker assay will be used to quantify levels of misfolded alpha-synuclein aggregates in biofluid samples from patients with Parkinson's disease, multiple system atrophy, rapid eye movement sleep behavior disorder, normal pressure hydrocephalus and controls.
|
Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
For PD subjects:
Inclusion Criteria:
Exclusion Criteria:
MSA Subjects:
Inclusion Criteria:
Exclusion Criteria
For RBD Subjects:
Inclusion Criteria:
Exclusion Criteria
For NPH:
Inclusion Criteria:
Exclusion Criteria:
For Controls:
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandra L Skinner, PhD | 631-444-7513 | sandra.skinner@stonybrookmedicine.edu |
United States, New York | |
Stony Brook University Medical Center | Recruiting |
Stony Brook, New York, United States, 11794-8121 | |
Contact: Sandra Skinner, PhD 631-444-7513 sandra.skinner@stonybrookmedicine.edu | |
Principal Investigator: Carine Maurer, MD,PhD |
Principal Investigator: | Carine W. Maurer, MD, PhD | Stony Brook University Medical Center |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | July 10, 2019 | ||||
First Posted Date | July 15, 2019 | ||||
Last Update Posted Date | March 29, 2021 | ||||
Actual Study Start Date | January 15, 2020 | ||||
Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Compare levels of misfolded alpha-synuclein aggregates in participants with PD, MSA, RBD, NPH and controls [ Time Frame: 3 weeks ] Levels of misfolded alpha-synuclein in CSF, serum, plasma, saliva, and urine will be quantified using the protein misfolding cyclic amplification (PMCA) technology
|
||||
Original Primary Outcome Measures |
Compare levels of misfolded alpha-synuclein aggregates in participants with PD, MSA, and controls [ Time Frame: 3 weeks ] Levels of misfolded alpha-synuclein in CSF, serum, plasma, saliva, and urine will be quantified using the protein misfolding cyclic amplification (PMCA) technology
|
||||
Change History | |||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients With Synucleinopathies | ||||
Official Title | A Pilot Biomarker Study Assessing Alpha-synuclein Aggregates Across Biofluid Reservoirs in Patients With Synucleinopathies | ||||
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 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. |
||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Other |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description:
CSF, plasma, serum, urine
|
||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Subjects with PD, MSA, RBD, NPH and controls | ||||
Condition |
|
||||
Intervention | Other: Biomarker assay
Biomarker assay will be used to quantify levels of misfolded alpha-synuclein aggregates in biofluid samples from patients with Parkinson's disease, multiple system atrophy, rapid eye movement sleep behavior disorder, normal pressure hydrocephalus and controls.
|
||||
Study Groups/Cohorts |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
24 | ||||
Original Estimated Enrollment |
18 | ||||
Estimated Study Completion Date | June 1, 2022 | ||||
Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
For PD subjects: Inclusion Criteria:
Exclusion Criteria:
MSA Subjects: Inclusion Criteria:
Exclusion Criteria
For RBD Subjects: Inclusion Criteria:
Exclusion Criteria
For NPH: Inclusion Criteria:
Exclusion Criteria:
For Controls: Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | 50 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
|
||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04020198 | ||||
Other Study ID Numbers | SNCA | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement |
|
||||
Responsible Party | Carine Maurer, Stony Brook University | ||||
Study Sponsor | Stony Brook University | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | Stony Brook University | ||||
Verification Date | March 2021 |