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RECRUITING
NCT07286448
NA

Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

Sponsor: Giovanna Zamboni

View on ClinicalTrials.gov

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.

Official title: Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment: the COG-FIT Pragmatic Trial

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-11-28

Completion Date

2026-11-30

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DEVICE

RICORDO

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.

BEHAVIORAL

S.A.M.B.A.

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.

Locations (1)

Azienda Ospedaliero Universitaria di Modena

Modena, Reggio Nell'Emilia (RE), Italy