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Transcultural and Multidimensional Validation of dIgital Rehabilitation Intervention of COgnitive Resources Domain-Oriented - Work Package 4

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Fondazione Don Carlo Gnocchi ONLUS; Center of Advance Diagnostic and Therapy ( CADiTeR)
RECRUITING
Milan
Contact Information
Primary
Valeria Blasi, MD
vblasi@dongnocchi.it
+390240308952
Backup
Chiara Pagliari, PhD
cpagliari@dongnocchi.it
+390240308952
Time Frame
Start Date: 2025-10-06
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 102
Treatments
Experimental: RICORDO
Participants will carry out telerehabilitation using a digital platform \[http://www.ricordo-dtx.com/\], at home, autonomously.
Active_comparator: Treatment as Usual (TAU)
Participants will follow a traditional paper-and-pencil rehabilitation protocol at home, autonomously.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Don Carlo Gnocchi Onlus
Collaborators: ASTIR, Università Carlo Cattaneo , Castellanza

This content was sourced from clinicaltrials.gov