RICORDO digital cognitive rehabilitation program for older adults

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

This project will test whether the RICORDO digital rehabilitation program can help people aged 65 and older with subjective memory complaints, mild cognitive impairment, or mild Alzheimer's dementia improve thinking skills and better manage their own health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Fondazione Don Carlo Gnocchi Onlus (other)
• Locations: 1 site (Milan)
• Trial ID: NCT07064226 on ClinicalTrials.gov

What this trial studies

This interventional comparison tests RICORDO, an adaptive digital telerehabilitation system, against standard paper-and-pencil cognitive rehabilitation (treatment as usual). Participants aged 65+ with subjective memory complaints, mild cognitive impairment, or mild dementia receive a tailored multidomain rehabilitation pathway delivered by RICORDO or by usual care, supported by a caregiver as needed. Neuropsychological evaluations are performed immediately before, immediately after, and six months after the program to measure changes in global cognition and patient activation. The protocol requires stable medications and excludes people with major sensory, motor, or communication barriers or those already engaged in rehabilitation.

Who should consider this trial

Good fit: Ideal candidates are people aged 65 or older with MoCA scores above 17.79, CDR ≤ 1, at least three years of education, a willing caregiver/study partner, and stable pharmacologic treatment for the past three months if applicable.

Not a fit: Patients with moderate-to-severe dementia, marked auditory/visual/communication impairments, significant motor problems, or those currently enrolled in another rehabilitation program are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, RICORDO could improve overall cognitive function and patient engagement while providing a scalable, adaptable telerehabilitation option.

How similar studies have performed: Earlier telerehabilitation and digital cognitive-training studies in MCI and early dementia have shown modest benefits, but fully adaptive systems like RICORDO are relatively novel and less well-established.

Eligibility criteria

Inclusion Criteria:

1. Montreal Cognitive Assessment (MoCA) score \> 17.79;
2. Clinical Dementia Rating (CDR) Scale score ≤ 1;
3. Education level \> 3 years;
4. Age ≥ 65 years;
5. Informed consent to participate, confirmed by signing the consent form;
6. Availability of a caregiver/study partner able to support the participant;
7. Stable pharmacological treatment (past 3 months) with acetylcholinesterase inhibitors, if applicable.

Exclusion criteria:

1. Presence of dysmetria or marked auditory/visual or communication disorders preventing the participation to the trial;
2. Presence of ongoing rehabilitation program at the time of enrollment or in the 3 months prior to enrollment;

Where this trial is running

Milan

• IRCCS Fondazione Don Carlo Gnocchi ONLUS; Center of Advance Diagnostic and Therapy ( CADiTeR) — Milan, Italy (RECRUITING)

Study contacts

• Principal investigator: Valeria Blasi, Medical Doctor — IRCCS Fondazione Don Carlo Gnocchi ONLUS
• Study coordinator: Valeria Blasi, MD

Conditions: Mild Cognitive Impairment, Subjective Memory Complaint, Dementia Alzheimer Type, telerehabilitation, Alzheimer disease, cognitive decline, cognitive rehabilitation, Digital medicine