Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT07286448

Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

Led by Giovanna Zamboni · Updated on 2026-04-29

100

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

G

Giovanna Zamboni

Lead Sponsor

I

IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Azienda Ospedaliero Universitaria di Modena

Modena, Reggio Nell'Emilia (RE), Italy, 42122

Actively Recruiting

2

IRCCS "S. Maria Nascente"

Milan, Italy, 20148

Actively Recruiting

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Research Team

G

Giovanna Zamboni, M.D, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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