ClinicalTrials.gov record NCT05253560

Prodromal Parkinsonian Features in GBA1 Mutation Carriers

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Prodromal Parkinsonian Features in GBA1 Mutation Carriers

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age40 years old to 75 years old
SexAll
LocationIsrael
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study compares non-invasive tests for early signs of Parkinson's disease in three groups: GBA1 mutation carriers, people with Gaucher disease, and healthy non-carrier controls. Participants complete a set of sensory tests, blood tests, blood pressure measurements, brain ultrasound, neurological examinations, and questionnaires. The study aims to find patterns that could help identify carriers at higher risk of developing Parkinson's.

What it is studying. The study looks for early (prodromal) signs of Parkinson's disease across several domains—anatomy, thinking and mood, sleep, and motor function—and combines test results with risk factors (age, sex, GBA1 variant type, caffeine and tobacco use, chemical exposures, family history) to build a model that may identify carriers at higher risk of developing Parkinson's.

What the researchers hope to learn. To determine how often prodromal Parkinson signs occur in GBA1 carriers and in Gaucher patients versus healthy controls, and to build a model using test results and risk factors to identify carriers at greater risk of developing Parkinson's.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Objective of the trial. To define a sub-population which is at increased risk of developing Parkinson, beyond the fact of carrying Gaucher; in this sub-population the investigators shall conduct a comprehensive evaluation that includes a variety of non-invasive tests, whose purpose is to evaluate the state of the pre- Parkinson's disease signs, signs which can appear, even twenty years before the appearance of the disease, and also to compare them to a group of diagnosed Gaucher patients and a group of healthy people who are not carriers of Gaucher disease. A group of those carriers will be available for trial or for treatment, if there will be a medicine for the prevention of the development of Parkinson, obtainable.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • The investigators aim to identify prodromal PD in a cohort of carriers of Gaucher disease.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Willing to participate

Exclusion criteria

  • PD patients
  • Dementia

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The carriers, the healthy people and the Gaucher patients will undergo a number of non-invasive tests, which test the pre-Parkinson signs. The tests are based on various sense tests, blood tests, measuring of blood pressure, lying and standing, ultra-sound of the brain and a neurological test (test of the nervous system and various questionnaires).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants undergo a set of predefined non-invasive tests (about 15 tests) to look for early signs of Parkinson disease. Tests described in the record include sensory tests, blood tests, lying-and-standing blood-pressure measurements, brain ultrasound, a neurological exam, and questionnaires about symptoms, sleep and cognition. Results and risk-factor information (for example age, sex, variant type, and exposures) are recorded for comparison across carriers, Gaucher patients, and healthy controls.

How the study is structured. An observational cohort study with a cross-sectional design. Three groups (GBA1 carriers, Gaucher patients, and healthy non-carrier controls) undergo a one-time battery of non-invasive tests and questionnaires to compare signs of prodromal Parkinson's between groups.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Israel. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 16, 2017
Primary completion
Jan 16, 2030 (estimated)
Study completion
Dec 31, 2030 (estimated)
Target enrollment
600 participants (estimated)
Last updated on registry
Apr 29, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Shaare Zedek Medical Center
Principal investigator
Ari Zimran, Prof.
Shaare Zedek Medical Center

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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