Parkinson's Disease Trial, Recruiting NCT04239079 Sponsor: Columbia University Condition: Parkinson's Disease
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Parkinson's Disease Trial, Recruiting

NCT04239079
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

This trial has four separate groups. Each group has its own criteria:

Group 1 – People with Parkinson's disease (PD):

  • A doctor has diagnosed Parkinson's disease based on established UK Brain Bank criteria, and the person has at least two of these three symptoms: resting tremor (shaking at rest), muscle stiffness, or slowness of movement — and those symptoms respond to Parkinson's medication
  • Age 55 or older at the time of joining the trial
  • Motor symptoms (movement problems) began after age 45
  • Parkinson's disease first appeared between the ages of 50 and 75
  • Willingness to take part in genetic testing and studies

Group 2 – Healthy people (age-matched controls for the PD group):

  • Age 55 or older
  • No close blood relatives (parents, siblings, children) diagnosed with Parkinson's disease
  • A score of 26 or higher on a standard memory and thinking test called the MoCA
  • Willingness to take part in genetic testing and studies

Group 3 – People with mild Alzheimer's disease or mild memory-related cognitive impairment (AD/aMCI):

  • A doctor has diagnosed mild Alzheimer's disease or amnestic mild cognitive impairment (early-stage memory problems), with a Clinical Dementia Rating (CDR) score of 0.5 or 1 (confirm with trial site)
  • Age 55 or older
  • A score between 20 and 26 on a standard thinking and memory test called the MMSE
  • Willingness to take part in genetic testing and studies

Group 4 – Healthy people (age-matched controls for the AD/aMCI group):

  • Healthy volunteers age 55 or older
  • A CDR score of 0 (meaning no signs of dementia) (confirm with trial site)
  • A score of 26 or higher on the MoCA memory and thinking test
  • Willingness to take part in genetic testing and studies

Who may not be able to join:

For people with Parkinson's disease (Group 1):

  • Signs suggesting a different, more complex movement disorder (such as PSP, MSA, or CBD), including problems with balance and coordination, certain eye movement difficulties, or significant loss of automatic body functions (such as blood pressure control)
  • Currently taking or having started antipsychotic (neuroleptic) medications around the time movement symptoms began
  • History of multiple strokes that caused a step-by-step worsening of movement symptoms
  • History of repeated serious head injuries
  • History of a definite brain infection (encephalitis)
  • Significant balance or walking problems appearing early in the disease (within the first 5 years)
  • A history of dementia
  • A cancer diagnosis in the past 3 years (skin cancer is not an exclusion)
  • An autoimmune disease (where the immune system attacks the body)
  • A disease affecting the immune system, such as chronic leukaemia or HIV
  • Currently on long-term medication that affects the immune system, such as oral steroids, azathioprine, or rituximab
  • Unable to give informed consent to participate

For healthy controls in the PD group (Group 2):

  • A cancer diagnosis in the past 3 years (skin cancer is not an exclusion)
  • An autoimmune disease
  • A disease affecting the immune system, such as chronic leukaemia or HIV
  • Currently on long-term medication that affects the immune system, such as oral steroids, azathioprine, or rituximab
  • Unable to give informed consent to participate

For people with AD/aMCI (Group 3):

  • A different type of dementia, such as frontotemporal dementia, Dementia with Lewy bodies, Parkinson's disease dementia, PSP, or corticobasal degeneration
  • A history of Parkinson's disease
  • A cancer diagnosis in the past 3 years (skin cancer is not an exclusion)
  • An autoimmune disease
  • A disease affecting the immune system, such as chronic leukaemia or HIV
  • Currently on long-term medication that affects the immune system, such as oral steroids, azathioprine, or rituximab
  • Unable to give informed consent to participate

For healthy controls in the AD/aMCI group (Group 4):

  • A history of Parkinson's disease
  • A cancer diagnosis in the past 3 years (skin cancer is not an exclusion)
  • An autoimmune disease
  • A disease affecting the immune system, such as chronic leukaemia or HIV
  • Currently on long-term medication that affects the immune system, such as oral steroids, azathioprine, or rituximab
  • Unable to give informed consent to participate

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Karen Marder, MD, MPH, Columbia University

Phone: 646-774-5064

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 May 2019
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percentage of subjects with T-cell immune response

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov