Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes

Parkinson Disease Clinical Trial

Official title:

Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes in Patients Undergoing Dopaminergic Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329739
• Other study ID #: NeuroPsico_Dopa&PD
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Parkinson Disease

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