Autoimmune Features of Neurodegenerative Disorders

Launched by COLUMBIA UNIVERSITY · Jan 21, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how inflammation might affect conditions like Parkinson's disease (PD) and Alzheimer's disease (AD). Researchers want to learn more about the immune system's role in these diseases by comparing the blood and health information of people with PD and AD to that of healthy individuals. They are looking to recruit a total of 120 participants: 30 with Parkinson's disease, 30 with Alzheimer’s or Mild Cognitive Impairment (aMCI), and 60 healthy age-matched controls.

To participate, you need to be at least 55 years old and meet specific health criteria related to your condition. For example, those with Parkinson's must have a confirmed diagnosis and show certain symptoms, while those with Alzheimer’s or aMCI must have a clinical diagnosis and a specific level of cognitive function. Participants will attend up to two visits where they will answer some brief questionnaires and provide blood samples (up to about 17 tablespoons total, but smaller options are available). There are also options for participating from home, including having a certified professional come to collect blood. If you decide to take part, you will be contributing valuable information that may help improve our understanding of these neurodegenerative conditions.

Gender

ALL

Eligibility criteria

• PD and age matched controls:
• For PD participants (n=30):
• Inclusion criteria:
• • 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
• Exclusion criteria:
• • 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):
• Inclusion criteria:
• • 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
• Exclusion criteria:
• • 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):
• Inclusion criteria:
• • 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
• Exclusion criteria:
• • 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):
• Inclusion criteria:
• • Healthy volunteers ≥55 years old
• • CDR: 0
• • MoCA: ≥26
• • Willingness to have genotyping and genetic studies
• Exclusion criteria:
• • 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