NCT07286448 · RECRUITING
Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment
This trial tests a home-based digital brain-training app called RICORDO against a paper-and-video education program called S.A.M.B.A. in people aged 50 and older with mild cognitive impairment or subjective cognitive decline. The main goal is to see whether RICORDO better helps participants manage their own health and daily life. It is a Phase NA trial — meaning it is evaluating a device or behavioral approach rather than a drug, so it follows a different regulatory path than a pharmaceutical study.
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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-04-29