Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

Summary

The goal of this clinical trial is to determine whether a home-based digital cognitive-training program called RICORDO can enhance patients' ability to manage their own health and daily life when they have Mild Cognitive Impairment (MCI) or Subjective Cognitive Decline (SCD) and are 50 years of age or older. The main questions it aims to answer are: Does using RICORDO for five weeks raise the Patient Activation Measure (PAM) score more than an at-home paper-and-video education program called S.A.M.B.A.? Does RICORDO also improve cognition, everyday functioning, quality of life and mood compared with S.A.M.B.A.? Researchers will compare individuals who train with RICORDO to those who follow S.A.M.B.A. to determine which approach is more effective. Participants will be randomly assigned to one of the two groups and complete three 45-minute sessions per week at home for five weeks. They will also visit the clinic at the beginning and end of the program to complete questionnaires and take brief thinking tests.

Interventions

• RICORDO · DEVICE

  RICORDO is a CE-marked digital therapeutic for cognitive rehabilitation, delivered via tablet. The program consists of home-based sessions, each lasting approximately 45 minutes. Tasks are automatically adapted based on the participant's baseline cognitive profile and real-time performance. Clinicians remotely monitor adherence and adjust the prescription through a web platform.

• S.A.M.B.A. · BEHAVIORAL

  S.A.M.B.A. (Socialisation, Alimentazione, Movimento, Benessere psicologico, Ambiente) is a structured, home-based lifestyle education program. Participants receive printed and video materials and complete sessions covering key domains of brain-healthy behavior. This arm is matched in duration and frequency to the experimental arm but includes no cognitive training.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Diagnosis of Mild Cognitive Impairment (MCI) based on Petersen (1999) and Winblad (2004), or Subjective Cognitive Decline (SCD) according to Jessen (2014)
* Mini-Mental State Examination (MMSE) \> 18 and Clinical Dementia Rating (CDR) ≤ 1
* Age ≥ 50 years
* Formal education \> 3 years
* Signed informed consent
* Stable neurotropic pharmacological therapy in the past 3 months (if applicable)
* Preserved mental capacity (i.e., not under legal guardianship or protective supervision)
* Preserved ability to understand and produce written and spoken Italian

Exclusion Criteria:

* Severe sensory or communication impairments
* Recent participation (\< 3 months) in cognitive or rehabilitation programs
* Failure to provide or withdrawal of informed consent
* History or evidence of central nervous system disorders that may affect cognition and are unrelated to the study (e.g., major stroke, brain tumors, normal pressure hydrocephalus, traumatic brain injury)
* History or evidence of major psychiatric disorders
* Presence of medical conditions that may interfere with cognitive function (e.g., renal or hepatic failure, obstructive sleep apnea, hypothyroidism, vitamin B12 deficiency)

Sites (2)

• Azienda Ospedaliero Universitaria di Modena, Modena, Reggio Nell'Emilia (RE), Italy · RECRUITING
• IRCCS "S. Maria Nascente", Milan, Italy · RECRUITING