Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical examinations and clinical scales administration.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes in Patients Undergoing Dopaminergic Treatment
Overview
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.
Interventions
- Diagnostic test Clinical examinations and clinical scales administration
Psychometric assessment of cognitive and behavioral outcomes
Primary outcome measures
- Montreal Cognitive Assessment [Time frame: Annual assessments up to 5 years]
- Beck Depression Inventory [Time frame: Annual assessments up to 5 years]
- State-Trait Anxiety Inventory [Time frame: Annual assessments up to 5 years]
- Questionnaire for Impulsive-Compulsive Disorders in Parkinson [Time frame: Annual assessments up to 5 years]
- Pittsburgh Sleep Quality Index [Time frame: Annual assessments up to 5 years]
- Parkinson's Disease Questionnaire-8 [Time frame: Annual assessments up to 5 years]
- Minnesota Multiphasic Personality Inventory 2-RF [Time frame: Annual assessments up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
Identifiers
NCT: NCT06329739 · NeuroPsico_Dopa&PD