Tests cognitive training in people with Parkinson's disease who carry a GBA gene change
Compares how people with Parkinson's and a GBA gene change respond to cognitive training.
Key facts
- Who runs it
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Where
- Milan, ItalySee the site
- Trial code
- Registry title
- Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease
- Status
- Recruiting
- People taking part
- 68 people, planned
- Started
- 21 Dec 2021
- Expected to end
- Dec 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- Cognitive training
- Record updated
- 21 March 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Parkinson's disease who have had genetic screening and are in a cognitive stimulation program as part of regular care.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Parkinson's disease diagnosed by the Gelb et al. criteria, with a Montreal cognitive assessment (MoCA) raw score from 15.50 to 22.23.
- Earlier treatment
- Must be in a cognitive stimulation program as part of regular clinical practice. People treated with deep brain stimulation (DBS-STN) cannot join.
- Biomarker or test result
- Must have had genetic screening. The study compares people with a GBA mutation to people without a genetic mutation.
Main reasons for not taking part
- Suspected Parkinson's disease later found to be a different illness
- A diagnosis of Parkinson's disease with a cognitive profile of dementia
- Deep brain stimulation (DBS-STN) treatment
- Refusing consent to take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Patients with a diagnosis of MP and cognitive profile of dementia
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Italy
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyContact: Fabiana Ruggiero, MSc in PsychologyTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- PD with GBA gene mutation
Patients with Parkinson's disease and GBA gene mutation treated with cognitive training
Treatment: Cognitive training
- PD without genetic mutation
Patients with Parkinson's disease without genetic mutation treated with cognitive training
Treatment: Cognitive training
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease
- Plain-language title
- Tests cognitive training in people with Parkinson's disease who carry a GBA gene changeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06323278, who can take part
- Record updated
- 21 March 2024