RecruitingNCT04239079

Autoimmune Features of Neurodegenerative Disorders

Sponsor

Columbia University

Enrollment

120 participants

Start Date

May 1, 2019

Study Type

OBSERVATIONAL

Conditions

Alzheimer Disease Parkinson Disease Mild Cognitive Impairment

Summary

This study is being conducted to better understand the role of inflammation in Parkinson's disease (PD) and Alzheimer's disease (AD). The investigators plan to recruit 30 PD, 30 AD/Amnestic Mild Cognitive Impairment (aMCI), and 60 age matched healthy controls in this study to study the role of immune response in PD and AD. The study involves up to two study visits involving brief questionnaires and blood draw of up to 250cc (approximately 17 tablespoons) to be collected. More ways to participate, including 1) smaller amount blood donation (up to 100cc per visit for 1-2 visits); and 2) participation via tele-visit and mobile phlebotomy visits (blood donation up to 50cc, \~5 tubes, by a certified mobile phlebotomist at home/location of choice) now available.

Eligibility

Min Age: 55 YearsMax Age: 90 Years

Inclusion Criteria19

PD and age matched controls:
For PD participants (n=30):
Clinical diagnosed PD based on UK Brain Bank criteria for the clinical diagnosis of PD. And must demonstrate two of the following three, as modified from BioFIND criteria: rest tremor, rigidity, or bradykinesia, with dopaminergic medication benefit
Age at recruitment ≥ 55
Age at motor onset \> 45
PD onset age between 50-75 years
Willingness to have genotyping and genetic studies
Ages ≥55 years old
With lack of PD in first-degree blood relatives
Montreal Cognitive Assessment (MoCA): ≥26
Willingness to have genotyping and genetic studies
Clinically diagnosed mild AD/amnestic MCI. The severity will be accessed through the Clinical Dementia Rating Scale (CDR). CDR equal to 0.5 or 1 will be necessary to meet criteria. Participants with advanced AD stage will not be capable to give their consent.
Age ≥55 years old
Mini-Mental State Exam (MMSE): 20-26
Willingness to have genotyping and genetic studies
Healthy volunteers ≥55 years old
CDR: 0
MoCA: ≥26
Willingness to have genotyping and genetic studies

Exclusion Criteria29

Atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure, neuroleptic treatment at time of onset of parkinsonism, active treatment with a neuroleptic at time of study entry, history of repeated strokes with stepwise progression of parkinsonism, history of repeated head injury, history of definite encephalitis, prominent gait imbalance early in the course (\< 5 years)
History of Dementia
Recent history of cancer (past 3 years), except skin cancer
Autoimmune disease
Disease of the immune system (e.g. chronic leukemia, HIV)
On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
Inability to provide informed consent.
For age-matched control participants (n=30):
Recent history of cancer (past 3 years), except skin cancer
Autoimmune disease
Disease of the immune system (e.g. chronic leukemia, HIV)
On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
Inability to provide informed consent
AD/aMCI and age matched controls:
For AD/aMCI participants (n=30):
Other forms of dementia including frontotemporal dementia or other dementia associated with parkinsonism such as Dementia with Lewy bodies (DLB), or Parkinson's disease Dementia (PDD), Progressive Supranuclear Palsy or corticobasal degeneration.
History of Parkinson's disease (PD)
Recent history of cancer (past 3 years), except skin cancer
Autoimmune disease
Disease of the immune system (e.g. chronic leukemia, HIV)
On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
Inability to provide informed consent
For age-matched control participants (n=30):
History of Parkinson's disease (PD)
Recent history of cancer (past 3 years), except skin cancer
Autoimmune disease
Disease of the immune system (e.g. chronic leukemia, HIV)
On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
Inability to provide informed consent