---
title: Find immune signs identifying Parkinson
nct_id: NCT04239079
status: RECRUITING
sponsor: Columbia University
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT04239079"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04239079"
last_fetched: "2026-05-10T14:03:26.145Z"
source: "Parkinson's Pathways (curated)"
---
# Find immune signs identifying Parkinson

**Goal (in five words):** Find immune signs identifying Parkinson

**Official Title:** Autoimmune Features of Neurodegenerative Disorders

**Trial ID:** [NCT04239079](https://clinicaltrials.gov/study/NCT04239079)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Columbia University
- **Target Enrollment:** 120 participants
- **Start Date:** 2019-05-01
- **Completion Date:** 2026-06
- **Conditions:** Parkinson Disease, Alzheimer Disease, Mild Cognitive Impairment

## Summary For Families

The goal is to look for autoimmune or immune-system patterns that might be linked to Parkinson's, Alzheimer's, and amnestic mild cognitive impairment, to better understand whether immune responses play a role in these brain disorders. Instead of testing a treatment, researchers will collect genetic data and immune-related measurements along with clinical assessments to compare immune markers and genotypes across people with PD, AD/aMCI, and age-matched healthy volunteers. The idea is to identify immune pathways or biomarkers that could guide future treatments or help distinguish disease types. Enrollment is for people aged 55 to 90, with about 30 in each group: PD participants with motor onset between 50 and 75 who show classic signs and dopaminergic benefit, people with mild AD/aMCI (MMSE about 20,26), and healthy controls; anyone with autoimmune disease, major immune disorders, recent cancer, or on chronic immune-modulating therapy is excluded.

## Eligibility

- **Minimum age:** 55 Years
- **Maximum age:** 90 Years
- **Sex:** ALL

### Full 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
```

## Locations (1)

- Columbia University Medical Center, New York, New York, United States _(40.7143, -74.0060)_
  - Kim Tran — (CONTACT) — 646-774-5023 — nkt2118@cumc.columbia.edu

## Central Contacts

- Ellen Kanter — (CONTACT) — 646-774-5064 — ek289@cumc.columbia.edu

---

*Canonical: https://parkinsonspathways.com/trial/NCT04239079*  
*HTML version: https://parkinsonspathways.com/trial/NCT04239079*  
*Source data: https://clinicaltrials.gov/study/NCT04239079*