Validation of a Digital Intervention to Rehabilitate Cognitive Resources
Recruiting · NCT07064226 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione Don Carlo Gnocchi ETS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to learn if the use of a digital cognitive rehabilitation system named RICORDO, that is flexible and capable of adapting the rehabilitation pathway according to the needs and capacity of the patients will prove effective for subjects with Subjective Memory Complaint or with Mild Cognitive Impairment or with Mild Dementia. The main questions it aims to answer are: Will the RICORDO rehabilitation treatment, lead to an improvement in the global cognitive level? Will the RICORDO rehabilitation treatment lead to improved activation of participants in managing their own health and healthcare? Researchers will compare the multidomain cognitive rehabilitation strategy of RICORDO digital solution, with a standard paper pencil rehabilitation care (usual care). Participants will undergo a comprehensive neuropsychological evaluation immediately before, immediately after and six months after the completion of the rehabilitation program. Both interventions, the experimental and the usual care, will last 5 weeks, with 3 weekly sessions of 45 minutes each and can be done autonomously by the patient at home.
Who can take part
Inclusion criteria
- Montreal Cognitive Assessment (MoCA) score \> 17.79;
- Clinical Dementia Rating (CDR) Scale score ≤ 1;
- Education level \> 3 years;
- Age ≥ 65 years;
- Informed consent to participate, confirmed by signing the consent form;
- Availability of a caregiver/study partner able to support the participant;
- Stable pharmacological treatment (past 3 months) with acetylcholinesterase inhibitors, if applicable.
Exclusion criteria
- Presence of dysmetria or marked auditory/visual or communication disorders preventing the participation to the trial;
- Presence of ongoing rehabilitation program at the time of enrollment or in the 3 months prior to enrollment;
Where it is running
1 location listed.
- IRCCS Fondazione Don Carlo Gnocchi ONLUS; Center of Advance Diagnostic and Therapy ( CADiTeR) - Milan, Italy