Clinical trial NCT06323278: Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease
Official title: Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
GBA gene mutation
Cognitive training
Psychological and behavioral aspects
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Experimental group: 34 PD patients with GBA gene mutation and undergoing cognitive stimulation treatment;
* Control group: 34 patients with idiopathic PD without known genetic mutation undergoing cognitive stimulation treatment.

The allocation of subjects to the two groups will be paired (1:1) by age ( 2 aa), sex, staging and duration of the disease.

Brief summary: The goal of this observational study is to evaluate the relationship between GBA mutation and cognitive stimulation treatment response in patients with Parkinson's disease. The main questions it aim to answer are: • assess whether the GBA mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of PD patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment.

Participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. Researchers will compare PD patients with GBA mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's disease according to the Gelb et al. criteria;
* Patients who have carried out genetic screening for MP;
* Patients who have a raw score in the range 15.50 to 22.23 at Montreal cognitive assessment (MoCA);
* Patients who have signed the informed consent and the Privacy Policy;
* Patients who are included in cognitive stimulation programs according to regular clinical practice.

Exclusion Criteria:

* Patients with the initial suspicion of MP that during the diagnostic work-up they were suffering from a different pathology;
* Patients who have refused consent to participate in the study;
* Patients with a diagnosis of MP and cognitive profile of dementia;
* Patients undergoing deep brain neurostimulation (DBS-STN) treatment. Patients treated with DBS-STN were excluded because such treatment involves a surgical procedure whose effects on cognitive functioning could represent an interfering variable.

Primary outcomes:
measure: Efficacy of the cognitive training on cognitive function in PD patients with GBA mutation compared to a control group of PD patients without genetic mutations.
timeFrame: Baseline and Six months follow-up post cognitive training
Secondary outcomes:
measure: The effect of cognitive training on behavioural aspects in PD patients.
timeFrame: Baseline and Six months follow-up post cognitive training
measure: The effect of cognitive training on behavioural aspects in PD patients.
timeFrame: Baseline and Six months follow-up post cognitive training
measure: The effect of cognitive training on behavioural aspects in PD patients.
timeFrame: Baseline and Six months follow-up post cognitive training
measure: The effect of cognitive training on behavioural aspects in PD patients.
timeFrame: Baseline and Six months follow-up post cognitive training
measure: The effect of cognitive training on behavioural aspects in PD patients.
timeFrame: Baseline and Six months follow-up post cognitive training
measure: The effect of cognitive training on behavioural aspects in PD patients.
timeFrame: Baseline and Six months follow-up post cognitive training
measure: The effect of cognitive training on behavioural aspects in PD patients.
timeFrame: Baseline and Six months follow-up post cognitive training
measure: The effect of cognitive training on behavioural aspects in PD patients.
timeFrame: Baseline and Six months follow-up post cognitive training
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
References: