NCT04239079Recruiting
Autoimmune Features of Neurodegenerative Disorders
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 21 Jan 2020
- Start date
- 1 May 2019
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Columbia University
- Diseases
- Alzheimer disease, Parkinson disease
- NCT number
- NCT04239079
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 May 2019 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
- On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
- On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
- On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)
Other illness
- 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)
- Recent history of cancer (past 3 years), except skin cancer
- Autoimmune disease
- Disease of the immune system (e.g. chronic leukemia, HIV)
- 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)
- 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)
Age
- Inability to provide informed consent.
- For age-matched control participants (n=30):
- Inability to provide informed consent
- AD/aMCI and age matched controls:
- For AD/aMCI participants (n=30):
- Inability to provide informed consent
- For age-matched control participants (n=30):
Other
- Inability to provide informed consent
Who the study is looking for
- 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
Criteria the registry did not label
- PD and age matched controls:
- For PD participants (n=30):
Age in the registry: 55 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.