Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes

NCT ID: NCT06329739

Last Updated: 2024-03-26

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

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-14

Study Completion Date

2031-12-14

Brief Summary

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The genetic landscape of Parkinson's disease (PD) is characterised by rare high penetrance pathogenic variants causing familial disease, genetic risk factor variants driving PD risk in a significant minority in PD cases and high frequency, low penetrance variants, which contribute a small increase of the risk of developing sporadic PD. This knowledge has the potential to have a major impact in the clinical care of people with PD.

The goal of this observational study is to evaluate the impact of genetic mutation on behavior and cognition in PD patients.

Patients will be assessed over time using test, questionnaire and standardised clinica scales. An initial assessment and annual follow-up assessments will be carried out for 5 years.

Researchers will compare data collected from patients with genetic mutation versus patients without mutation.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

Parkinson's Disease patients with genetic mutation

Clinical examinations and clinical scales administration

Intervention Type DIAGNOSTIC_TEST

Psychometric assessment of cognitive and behavioral outcomes

Control group

Parkinson's Disease patients without genetic mutation

Clinical examinations and clinical scales administration

Intervention Type DIAGNOSTIC_TEST

Psychometric assessment of cognitive and behavioral outcomes

Interventions

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Clinical examinations and clinical scales administration

Psychometric assessment of cognitive and behavioral outcomes

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* diagnosed with Parkinson's Disease (PD)
* in use of dopaminergic medication (L-Dopa and/or dopamine agonists)
* genetic testing for mendelian forms of PD
* able to provide informed consent to participate in the study

Exclusion Criteria

* Patients underwent Deep Brain Stimulation (DBS) treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesca Mameli, Dr

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesca Mameli, Dr

Role: CONTACT

0255033621

Fabiana Ruggiero, Dr

Role: CONTACT

0255033621

Facility Contacts

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Francesca Mameli

Role: primary

0255033621

Other Identifiers

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NeuroPsico_Dopa&PD

Identifier Type: -

Identifier Source: org_study_id

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