Understanding inflammation in Parkinson's and Alzheimer's diseases

Autoimmune Features of Neurodegenerative Disorders

This study is trying to understand how inflammation affects people with Parkinson's and Alzheimer's diseases by looking at their immune responses and comparing them to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 55 Years to 90 Years
• Sex: All
• Sponsor: Columbia University (other)
• Drugs / interventions: rituximab
• Locations: 1 site (New York, New York)
• Trial ID: NCT04239079 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the role of inflammation in Parkinson's disease (PD) and Alzheimer's disease (AD) by recruiting participants with these conditions and age-matched healthy controls. The study will involve up to two visits where participants will complete brief questionnaires and provide blood samples to analyze immune responses related to neurodegeneration. Researchers will focus on identifying specific proteins that may trigger inflammation and the T cells involved in recognizing these proteins. The ultimate goal is to uncover antigenic responses associated with PD and AD to better understand their autoimmune features.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease or Alzheimer's disease, as well as age-matched healthy controls aged 55 and older.

Not a fit: Patients with atypical Parkinsonian features or those with significant comorbidities that may confound results may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new insights into the autoimmune aspects of neurodegenerative diseases, potentially guiding future therapeutic strategies.

How similar studies have performed: Preliminary studies have indicated autoimmune features in neurodegenerative diseases, suggesting that this approach may yield valuable insights, although this specific study's methodology is relatively novel.

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

Where this trial is running

New York, New York

• Columbia University Medical Center — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Karen Marder, MD, MPH — Columbia University
• Study coordinator: Ellen Kanter

Conditions: Parkinson Disease, Alzheimer Disease, Mild Cognitive Impairment, Autoimmune features, Parkinson's disease, Alzheimer's disease