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
Sponsors and collaborators
Giovanna Zamboni
Lead sponsor
University of Modena and Reggio Emilia
Sponsor institution
IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan
Collaborator