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Prodromal Parkinsonian Features in GBA1 Mutation Carriers

NCT ID: NCT05253560

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-16

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Gaucher Disease, Type 1 Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Carriers of Gaucher disease

Family of patients with Gaucher disease, sequenced for the GBA1 gene.

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

Intervention Type DIAGNOSTIC_TEST

Tests to help identify prodromal PD in a cohort of carriers of Gaucher disease

Gaucher patients

Patients from the Gaucher clinic in Shaare Zedek Medical Center, Jerusalem, Israel

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

Intervention Type DIAGNOSTIC_TEST

Tests to help identify prodromal PD in a cohort of carriers of Gaucher disease

Healthy controls

Family members of Gaucher patients who are not carriers of Gaucher disease

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

Intervention Type DIAGNOSTIC_TEST

Tests to help identify prodromal PD in a cohort of carriers of Gaucher disease

Interventions

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

Tests to help identify prodromal PD in a cohort of carriers of Gaucher disease

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Willing to participate

Exclusion Criteria

* PD patients
* Dementia
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ari Zimran

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ari Zimran, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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Michal Becker- Cohen

Jerusalem, Please Select..., Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ari Zimran, MD

Role: CONTACT

[email protected]
+972-509149149

Michal Becker- Cohen, M.Sc.

Role: CONTACT

[email protected]
+972-504606310

Facility Contacts

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Ari Zimran, M.D.

Role: primary

[email protected]
+97226555143

Michal Becker- Cohen, M.Sc.

Role: backup

[email protected]
+97226555143

Other Identifiers

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SZMC-0168-17

Identifier Type: -

Identifier Source: org_study_id