NCT06323278Recruiting
Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease
Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 21 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 68 (estimated)
- First submitted
- 6 Mar 2024
- Start date
- 21 Dec 2021
- Primary completion date
- Dec 2026
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Diseases
- Parkinson disease
- NCT number
- NCT06323278
What you commit to
- Study type: Observational
- Planned participants: 68
- From 21 Dec 2021 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with a diagnosis of MP and cognitive profile of dementia;
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.