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New study aims to unravel Parkinson's protein mysteries

NCT ID NCT07474779

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how abnormal proteins, like alpha-synuclein and tau, build up and affect brain function in people with Parkinson's disease. Researchers will use brain scans, blood tests, and skin biopsies to track these changes. The goal is to find better ways to diagnose and understand the disease, not to test a new treatment.

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 research could identify new biomarkers and improve understanding of how Parkinson's disease progresses, potentially guiding future treatments.
What could go wrong
This is an early-stage observational study, not a treatment trial. It may not directly lead to new therapies, and results may not apply to all Parkinson's patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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.

Ages

18 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 for Parkinson's disease cohorts (GBA-PD and nonGBA-PD): * Diagnosis of PD according to MDS-PD criteria and, for the GBA-PD group, presence of heterozygous GBA mutations (with a balanced distribution of severe, risk, mild, and complex variants); * Disease duration between 3 and 7 years; * Disease stage according to Hoehn \& Yahr ≤ 3; * Absence of mutations in other known genes associated with PD susceptibility; * Age \> 18 Years; * Ability to understand and voluntarily sign informed consent and to comply with study procedures. Exclusion criteria for Parkinson's disease cohorts: * Diagnosis of atypical and/or secondary parkinsonism; * Diagnosis of dementia according to DSM-5 criteria; * Presence of other neurological disorders and/or essential tremor; * Presence of systemic inflammatory or infectious diseases, autoimmune diseases, or malignant tumors at the time of enrollment. Inclusion criteria for unaffected subjects (GBA-nonPD and nonGBA-nonPD): * Age \> 18 Years; * Ability to understand and voluntarily sign informed consent and to comply with study procedures; * No diagnosis of PD or other neurological disorders; * Presence of a heterozygous GBA mutation for the GBA-nonPD group and absence of such mutation for control subjects (nonGBA-nonPD); * Absence of mutations in other known genes associated with PD susceptibility. Exclusion criteria for unaffected subjects (GBA-nonPD and nonGBA-nonPD): * Presence of systemic inflammatory or infectious diseases, autoimmune diseases, or malignant tumors at the time of enrollment; * Diagnosis of atypical and/or secondary parkinsonism; * Diagnosis of dementia according to DSM-5 criteria. Inclusion criteria for subjects with idiopathic REM Sleep Behavior Disorder (GBA-iRBD and nonGBA-iRBD): * Diagnosis of idiopathic REM Sleep Behavior Disorder according to ICSD-3; * Age \> 18 Years; * Ability to understand and voluntarily sign informed consent and to comply with study procedures; * No diagnosis of PD or other neurological disorders; * Presence of a heterozygous GBA mutation for the GBA-iRBD group and absence of such mutation for the nonGBA-iRBD group; * Absence of mutations in other known genes associated with PD susceptibility. Exclusion criteria for subjects with idiopathic REM Sleep Behavior Disorder (GBA-iRBD and nonGBA-iRBD): * Presence of systemic inflammatory or infectious diseases, autoimmune diseases, or malignant tumors at the time of enrollment; * Diagnosis of atypical and/or secondary parkinsonism; * Diagnosis of dementia according to DSM-5 criteria.

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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

    2 sites. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Neurological Institute Foundation Casimiro Mondino

    Pavia, PV, 27100, Italy

  • University of Pavia

    Pavia, PV, 27100, Italy

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