Personalized digital training for cognitive fitness in people with mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

COG-FIT is a single-blind, randomized controlled trial enrolling 100 participants across two outpatient centers in Modena and Milan, Italy, to compare a personalized tablet-based cognitive rehabilitation program (RICORDO) with an active paper-and-video control (S.A.M.B.A.). Participants are randomly assigned 1:1 and complete 15 home sessions (three 45-minute sessions per week) over five weeks, with baseline and post-intervention clinic visits for outcome measurement. RICORDO is a CE-marked, adaptive digital therapeutic that individualizes exercises using cognitive profiles and ongoing performance, while S.A.M.B.A. delivers matched-duration lifestyle education. The primary endpoint is change in the Patient Activation Measure (PAM) with secondary endpoints including cognition, everyday functioning, quality of life, and mood assessed by blinded raters.

Why it matters

Who can join: the full rules

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)

Where it's running

• Azienda Ospedaliero Universitaria di Modena
  Modena, Reggio Nell'Emilia (RE), Italy Recruiting
• IRCCS "S. Maria Nascente"
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Giovanna Zamboni, M.D, PhD
• Email: giovanna.zamboni@unimore.it
• Phone: +39 059/3962201

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.