Autoimmune Features of Neurodegenerative Disorders

NCT04239079 | Recruiting

• 2 other identifiers: AAAS16691R01NS095 435-01A1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Alzheimer Disease; Mild Cognitive Impairment

Keywords

Autoimmune features; Parkinson's disease; Alzheimer's disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with T-cell immune response

  Blood samples from patients and controls will be processed. The presence of T cell response against the candidate antigens by patient blood-derived peripheral blood mononuclear cells (PBMC) will be assessed using an enzyme-linked immunosorbent spot (ELISPOT) assay.

  Week 1-2

Study Arms (2)

PD and Controls

50% of the participants will be healthy controls and 50% will be patients diagnosed with Parkinson's disease

AD/aMCI and Controls

50% of the participants will be healthy controls and 50% will be patients diagnosed with Alzheimer's disease or Amnestic Mild Cognitive Impairment (aMCI)

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinically confirmed Parkinson's disease and age matched controls; Patients with clinically confirmed Alzheimer's disease/ amnestic Mild Cognitive Impairment and age matched controls

You may qualify if:

• 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

You may not qualify if:

• 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):
• 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
• Recent history of cancer (past 3 years), except skin cancer
• Autoimmune disease
• Disease of the immune system (e.g. chronic leukemia, HIV)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (5)

• Sulzer D, Alcalay RN, Garretti F, Cote L, Kanter E, Agin-Liebes J, Liong C, McMurtrey C, Hildebrand WH, Mao X, Dawson VL, Dawson TM, Oseroff C, Pham J, Sidney J, Dillon MB, Carpenter C, Weiskopf D, Phillips E, Mallal S, Peters B, Frazier A, Lindestam Arlehamn CS, Sette A. T cells from patients with Parkinson's disease recognize alpha-synuclein peptides. Nature. 2017 Jun 29;546(7660):656-661. doi: 10.1038/nature22815. Epub 2017 Jun 21.

  PMID: 28636593 BACKGROUND

• Garretti F, Agalliu D, Lindestam Arlehamn CS, Sette A, Sulzer D. Autoimmunity in Parkinson's Disease: The Role of alpha-Synuclein-Specific T Cells. Front Immunol. 2019 Feb 25;10:303. doi: 10.3389/fimmu.2019.00303. eCollection 2019.

  PMID: 30858851 BACKGROUND

• Lindestam Arlehamn CS, Garretti F, Sulzer D, Sette A. Roles for the adaptive immune system in Parkinson's and Alzheimer's diseases. Curr Opin Immunol. 2019 Aug;59:115-120. doi: 10.1016/j.coi.2019.07.004. Epub 2019 Aug 17.

  PMID: 31430650 BACKGROUND

• Lindestam Arlehamn CS, Pham J, Alcalay RN, Frazier A, Shorr E, Carpenter C, Sidney J, Dhanwani R, Agin-Liebes J, Garretti F, Amara AW, Standaert DG, Phillips EJ, Mallal SA, Peters B, Sulzer D, Sette A. Widespread Tau-Specific CD4 T Cell Reactivity in the General Population. J Immunol. 2019 Jul 1;203(1):84-92. doi: 10.4049/jimmunol.1801506. Epub 2019 May 13.

  PMID: 31085590 BACKGROUND

• Lindestam Arlehamn CS, Dhanwani R, Pham J, Kuan R, Frazier A, Rezende Dutra J, Phillips E, Mallal S, Roederer M, Marder KS, Amara AW, Standaert DG, Goldman JG, Litvan I, Peters B, Sulzer D, Sette A. alpha-Synuclein-specific T cell reactivity is associated with preclinical and early Parkinson's disease. Nat Commun. 2020 Apr 20;11(1):1875. doi: 10.1038/s41467-020-15626-w.

  PMID: 32313102 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Parkinson Disease; Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Karen Marder, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• David Sulzer, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Julian P Agin-Liebes, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Kanter

CONTACT

646-774-5064; ek289@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 23, 2020
• Study Start: May 1, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)