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Could the immune system hold clues to brain diseases?

NCT ID NCT04239079

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study looks at whether the immune system's T-cells react differently in people with Parkinson's disease or Alzheimer's disease compared to healthy older adults. Researchers will collect blood samples from 120 participants—30 with Parkinson's, 30 with Alzheimer's or mild cognitive impairment, and 60 healthy controls—to measure T-cell responses to certain antigens. The goal is to better understand how inflammation and immune responses may be involved in these neurodegenerative conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If immune responses are found to differ, it could point toward new ways to understand or treat these brain diseases.
What could go wrong
This is an observational study, so it won't directly test a treatment. It may only show associations, not cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

55 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

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