Personalized digital training for cognitive fitness in people with mild cognitive impairment
Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment: the COG-FIT Pragmatic Trial
This study tests whether a personalized home-based digital program (RICORDO) helps people aged 50 and older with mild cognitive impairment or subjective cognitive decline manage their health and daily life better than a paper-and-video education program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Modena and Reggio Emilia Academic / other |
| Locations | 2 sites (Modena, Reggio Nell'Emilia (RE) and 1 other locations) |
| Trial ID | NCT07286448 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 or older with a diagnosis of MCI or SCD, MMSE > 18 and CDR ≤ 1, at least 3 years of formal education, Italian language ability, preserved capacity to consent, and stable neurotropic medication if applicable.
Not a fit: Patients with severe sensory or communication impairments, recent participation in cognitive rehabilitation, major unrelated CNS disorders, inability to use Italian-language tablet content, or more advanced dementia are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, RICORDO could increase patient activation and autonomy and lead to better daily functioning and quality of life for people with MCI or SCD.
How similar studies have performed: Previous digital cognitive-training programs have shown modest cognitive and functional benefits in MCI populations, but using an adaptive, CE-marked software specifically to boost patient activation is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Modena, Reggio Nell'Emilia (RE) and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.