Immune cells may hold the key to Parkinson's origins

NCT ID NCT07026929

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Recruiting now
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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 This study
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 Results may not be published yet.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)

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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

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Status unknown
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First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study explores whether the immune system plays a role in starting and driving Parkinson's disease. Researchers will collect blood, spinal fluid, stool, and saliva from people with REM sleep behavior disorder (a strong early sign of Parkinson's), people already diagnosed with Parkinson's, and healthy volunteers. They will look for immune cells that mistakenly attack a protein called alpha-synuclein, which is linked to Parkinson's, and check whether gut microbes might trigger this immune response. The goal is to understand how Parkinson's begins and progresses, which could lead to earlier detection or new prevention strategies.

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 successful, this could reveal early immune triggers of Parkinson's disease, pointing toward new ways to detect or prevent it before motor symptoms appear.
What could go wrong
This is an observational study, not a treatment trial. It may not prove cause and effect, and findings might not translate into clinical tools or therapies.

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Study facts

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

Participants

94 people

The number who actually took part.

Started

May 2021

Expected to finish

Jun 2031

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

Subjects will be recruited from outpatient neurology and sleep medicine clinics and from the community using flyers and social media postings. Subjects in general will be healthy adults seen in an outpatient research setting. There will be no limitation in ability to move or walk as most subjects will be pre-clinical except for Group 4 which will include persons with only minor motor symptoms (which never includes gait disturbance) of PD.

Ages

40 years and older

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.

Inclusion Criteria: General: * English Speaking * Able and willing to provide informed consent REM behavior disorder: * Repeated episodes of sleep-related vocalization and/or complex motor behaviors. These behaviors are documented by polysomnography to occur during REM sleep or, based on clinical history of dream enactment, are presumed to occur during REM sleep. * Polysomnographic recording demonstrates REM sleep without atonia (RWA). * The disturbance is not better explained by another sleep disorder, mental disorder, medication, or substance abuse. Parkinson's disease: * Meets the Movement Disorders Society criteria for Clinically Probable Parkinson's disease. * Disease duration \< 10 years 10 years from PD diagnosis at the time subject was first identified to be screened for the study. Healthy controls: * No clinical evidence of Parkinson's disease or RBD. * Normosmic. Exclusion Criteria: General: * Known immune deficiency disorder. * Personal history of any neurological disorder, including but not limited to: Multiple Sclerosis, Alzheimer's disease, Multiple System Atrophy, Progressive Supranuclear Palsy, Amyotrophic Lateral Sclerosis, or repeated head trauma. * Solid or hematological malignancy other than in-situ carcinoma of the cervix or basal cell carcinoma of the skin unless the subject has no evidence of active disease and has not received treatment, including chemotherapy, immunotherapy or radiation treatment within previous 12 months. * Known blood clotting disorder (with increased likelihood of bleeding). * Short Bowel Syndrome, Ileostomy, or colostomy * History of vagotomy. * Taking anticoagulant or antiplatet medication (coumadin, heparin, apixaban (Eliquis ®), rivaroxaban (Xalreto®), edoxaban (Lixiana®), or dabigatran (Praxeda®). Low-dose (100 mg/day or less) aspirin is allowed. Taking certain drugs that can interfere with interpretation of DaT scan, such as methylphenidate (Ritalin®), stimulant drugs such as phentermine or ephedrine, certain antidepressants, including mazindol, or radaraxine, benztropine (Cogentin®) within 5 half-lives prior to the date of the scheduled DaT scan. Subjects taking a potentially interfering medication can only be included if the medication is stopped with the concurrence of the subject and the prescribing health care provider. Persons taking bupropion or amphetamine will be asked to hold the medicine on the morning of the scan. They will be able to take the medicine the same day after the scan. Inability to hold bupropion or an amphetamine for the scan, however, will not exclude an individual from participating. * Receiving chemotherapy agents with ability to affect the immune system, or radiation therapy (within the past 12 months). * Receiving potent immunosuppressant agents (e.g., anti-TNF, or IL-6 antibodies, JAK/STAT inhibitors, chemotherapy agents such as methotrexate or Cytoxan used to induce immunosuppression), Use of low, maintenance doses of corticosteroids may be permitted, depending on the underlying disease indication. * Treatment with an experimental agent within 3 months of screening. * Pregnancy or actively breast feeding. * Treatment of thyroid disease with radioactive iodine. * Lidocaine allergy. Additional Exclusion Criteria for Subjects with diagnosis of PD: * Meets any of the MDS exclusionary criteria for PD diagnosis. Additional Exclusion Criteria for Subjects with RBD * An identified secondary cause of RBD. * Neurodegenerative Disease: Neurological examination must be performed to exclude parkinsonism (according to MDS PD criteria), and clinically evident dementia. * Secondary RBD, caused by antidepressant medications (antidepressant- triggered RBD can be included provided that diagnosis is documented of antidepressant medications, and patients can be taking antidepressants during the study). * Diagnosis of narcolepsy. Additional Exclusion Criteria for Healthy Control Subjects * History of Parkinson's disease in a first-degree blood relative.

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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.

Contacts and locations

Locations

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520, United States

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