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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06329739
Other study ID # NeuroPsico_Dopa&PD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 14, 2021
Est. completion date December 14, 2031

Study information

Verified date March 2024
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Francesca Mameli, Dr
Phone 0255033621
Email francesca.mameli@policlinico.mi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date December 14, 2031
Est. primary completion date December 14, 2031
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Clinical examinations and clinical scales administration
Psychometric assessment of cognitive and behavioral outcomes

Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montreal Cognitive Assessment Cognitive impairment change from baseline until 5 years in Montreal Cognitive Assessment (MoCA; min. 0, max. 30, higher score means better outcome) Annual assessments up to 5 years
Primary Beck Depression Inventory Depressive symptoms change from baseline to 5 year (BDI-II, min 0, max 63, higher score means worse outcome) Annual assessments up to 5 years
Primary State-Trait Anxiety Inventory Anxiety symptoms change from baseline to 5 year (STAI, min 20, max 80, higher score means worse outcome) Annual assessments up to 5 years
Primary Questionnaire for Impulsive-Compulsive Disorders in Parkinson Impulsivity change from baseline to 5 years (QUIP, min 0, max 112, higher score means worse outcome) Annual assessments up to 5 years
Primary Pittsburgh Sleep Quality Index Sleep Quality change (PSQI, min 0, max 21, higher score means poorer sleep quality) Annual assessments up to 5 years
Primary Parkinson's Disease Questionnaire-8 Quality of life change from baseline to 5 years (PDQ-8, min 0, max 100, higher score means worse outcome) Annual assessments up to 5 years
Primary Minnesota Multiphasic Personality Inventory 2-RF Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T>65 for clinical scales) Annual assessments up to 5 years
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