Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment (NCT07286448) | Clinical Trial Compass
RecruitingNot Applicable
Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment
Italy100 participantsStarted 2025-11-28
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.