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Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

NCT07286448 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Mild Cognitive Impairment (MCI)
  • Subjective Cognitive Decline (SCD)

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.

Sponsors & Collaborators

  • IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan

    collaborator UNKNOWN

  • Giovanna Zamboni

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-28
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286448 on ClinicalTrials.gov