Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorGiovanna Zamboni

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • RICORDO
  • S.A.M.B.A.

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Giovanna Zamboni

Lead sponsor

University of Modena and Reggio Emilia

Sponsor institution

IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan

Collaborator