Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Montreal Cognitive Assessment — 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 — 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 — 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 — 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 — 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 — 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 — Annual assessments up to 5 years
  Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T\>65 for clinical scales)

Trial sites (1)

More Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials in Italy

Other trials for the same condition