Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

Official title

Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment: the COG-FIT Pragmatic Trial

Overview

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.

Detailed description

The COG-FIT study is a pragmatic, single-blind, randomized controlled trial designed to assess the effectiveness of RICORDO, a CE-marked digital cognitive rehabilitation intervention, in improving patient activation and autonomy in individuals with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD).

The study is sponsored by the University of Modena and Reggio Emilia and funded under the Italian National Recovery and Resilience Plan (PNC0000007 - FIT4MEDROB). It is a post-marketing clinical investigation of a certified medical device software, conducted in accordance with EU Regulation 2017/745.

Participants (n=100) will be recruited from two outpatient centres in Modena and Milan, Italy. Eligible individuals will be randomly assigned (1:1) to either:

RICORDO group: 15 home-based sessions (3/week, 45 minutes each) using a personalized digital training program delivered via tablet, guided by adaptive algorithms based on the patient's MoCA profile, baseline clinical information and performance over time.

Active control group (S.A.M.B.A.): 15 sessions with video and printed materials on lifestyle domains (Social interaction, Nutrition, Physical activity, Psychological well-being, Environment), matched for duration and frequency.

Primary and secondary outcome measures will be collected at baseline (T0) and after 5 weeks (T1) by blinded assessors. The primary endpoint is the change in Patient Activation Measure (PAM). Secondary endpoints include cognitive function (MoCA, CRIq), functional status (WHODAS 2.0), quality of life (EQ-5D-5L), and neuropsychiatric symptoms (STAI-Y, BDI-II, MBI-C). Usability (SUS) and technology acceptance (TAM) will be assessed in the RICORDO group at T1.

Participants' adherence will be tracked digitally (RICORDO) or via logbooks (S.A.M.B.A.), with weekly phone support. Data will be pseudonymized and entered into REDCap servers hosted in Italy, which are managed in accordance with GDPR and national privacy laws.

The study is powered to detect a mean PAM difference of 8.8 points (SD = 12) based on previous trials. With α = 0.05, power = 90%, and a 20% dropout rate, the total sample size is set at 100. Statistical analyses will be conducted on an intention-to-treat basis, with imputation of missing data and sensitivity checks.

No invasive procedures or pharmacological interventions are planned. All participants will provide informed consent. Risk is minimal due to the non-invasive nature of the intervention, and adverse events will be closely monitored.

The total duration of the study is 12 months, with 9 months of recruitment and a 5-week intervention per participant. Results will be disseminated through open-access publications, public events, and the project's website.

Interventions

• Device RICORDO
  RICORDO is a CE-marked digital therapeutic for cognitive rehabilitation, delivered via tablet. The program consists of home-based sessions, each lasting approximately 45 minutes. Tasks are automatically adapted based on the participant's baseline cognitive profile and real-time performance. Clinicians remotely monitor adherence and adjust the prescription through a web platform.
• Behavioral S.A.M.B.A.
  S.A.M.B.A. (Socialisation, Alimentazione, Movimento, Benessere psicologico, Ambiente) is a structured, home-based lifestyle education program. Participants receive printed and video materials and complete sessions covering key domains of brain-healthy behavior. This arm is matched in duration and frequency to the experimental arm but includes no cognitive training.

Primary outcome measures

• Patient Activation Measure [Time frame: Baseline (T0) and 5 weeks (T1)]

Secondary outcome measures (9)

• Montreal Cognitive Assessment [Time frame: Baseline (T0) and 5 weeks (T1)]
• Cognitive Reserve Index questionnaire [Time frame: Baseline (T0) only]
• World Health Organization Disability Assessment Schedule 2.0 [Time frame: Baseline (T0) and 5 weeks (T1)]
• EuroQol-5 Dimension [Time frame: Baseline (T0) and 5 weeks (T1)]
• State-Trait Anxiety Inventory Form Y [Time frame: Baseline (T0) and 5 weeks (T1)]
• Beck Depression Inventory [Time frame: Baseline (T0) and 5 weeks (T1)]
• Mild Behavioral Impairment Checklist [Time frame: Baseline (T0) and 5 weeks (T1)]
• System Usability Scale [Time frame: 5 weeks (T1 only)]
• Technology Acceptance Model [Time frame: 5 weeks only (T1)]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Italy · 2 centers

• Azienda Ospedaliero Universitaria di Modena — Modena
• IRCCS "S. Maria Nascente" — Milan

Identifiers

NCT: NCT07286448 · 14610/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗