Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT06329739
Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Clinical examinations and clinical scales administration
Diagnostic TestPsychometric assessment of cognitive and behavioral outcomes
Primary outcomes
-
Montreal Cognitive Assessment
Time frame: Annual assessments up to 5 years
Cognitive impairment change from baseline until 5 years in Montreal Cognitive Assessment (MoCA; min. 0, max. 30, higher score means better outcome)
-
Beck Depression Inventory
Time frame: Annual assessments up to 5 years
Depressive symptoms change from baseline to 5 year (BDI-II, min 0, max 63, higher score means worse outcome)
-
State-Trait Anxiety Inventory
Time frame: Annual assessments up to 5 years
Anxiety symptoms change from baseline to 5 year (STAI, min 20, max 80, higher score means worse outcome)
-
Questionnaire for Impulsive-Compulsive Disorders in Parkinson
Time frame: Annual assessments up to 5 years
Impulsivity change from baseline to 5 years (QUIP, min 0, max 112, higher score means worse outcome)
-
Pittsburgh Sleep Quality Index
Time frame: Annual assessments up to 5 years
Sleep Quality change (PSQI, min 0, max 21, higher score means poorer sleep quality)
-
Parkinson's Disease Questionnaire-8
Time frame: Annual assessments up to 5 years
Quality of life change from baseline to 5 years (PDQ-8, min 0, max 100, higher score means worse outcome)
-
Minnesota Multiphasic Personality Inventory 2-RF
Time frame: Annual assessments up to 5 years
Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T>65 for clinical scales)
Study contacts
Contact information is provided by the study sponsor or research team.
Fabiana Ruggiero, Dr
CONTACT
Francesca Mameli, Dr
CONTACT
Sponsors and collaborators
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Other
Registry information
Official study title
Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes in Patients Undergoing Dopaminergic Treatment
Important dates
- Study start
- 2021
- Primary completion
- 2031
- Study completion
- 2031
- First posted
- Mar 26, 2024
- Registry last updated
- Mar 26, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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