Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

NCT07286448 | Recruiting

• 1 other identifier: 14610/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Subjective Cognitive Decline (SCD); Mild Cognitive Impairment (MCI)

Keywords

Mild Cognitive Impairment; Digital Therapeutics; Cognitive Rehabilitation; Patient Activation; Home-Based Intervention

Outcome Measures

Primary Outcomes (1)

• Patient Activation Measure

  The Patient Activation Measure (PAM) is a validated and highly reliable scale designed to assess a person's level of activation, defined as their ability to manage their own health and actively participate in care. The PAM identifies four progressive levels of activation: (1) awareness of the importance of one's role in managing health, (2) acquisition of the knowledge and confidence to take action, (3) initiation of health-related behaviors, and (4) consistent maintenance of those behaviors even under stress (Hibbard et al., 2004).

  Baseline (T0) and 5 weeks (T1)

Secondary Outcomes (9)

• Montreal Cognitive Assessment

  Baseline (T0) and 5 weeks (T1)

• Cognitive Reserve Index questionnaire

  Baseline (T0) only

• World Health Organization Disability Assessment Schedule 2.0

  Baseline (T0) and 5 weeks (T1)

• EuroQol-5 Dimension

  Baseline (T0) and 5 weeks (T1)

• State-Trait Anxiety Inventory Form Y

  Baseline (T0) and 5 weeks (T1)

Study Arms (2)

RICORDO - Digital Cognitive Rehabilitation

EXPERIMENTAL

Participants assigned to this arm will receive a 5-week personalized cognitive training program using the CE-marked digital therapeutic RICORDO. The intervention consists of 15 tablet-based home sessions (3 per week, 45 minutes each), tailored to the participant's cognitive profile and performance, and remotely monitored by clinicians via a web platform.

Device: RICORDO

S.A.M.B.A. - Lifestyle Education Program

ACTIVE COMPARATOR

Participants assigned to this arm will follow a 5-week home-based educational program called S.A.M.B.A., which includes 15 sessions (3 per week) using printed and video materials focused on socialization, healthy nutrition, physical activity, psychological well-being, and environmental stimulation. This arm is matched for contact time and format but does not include cognitive training.

Behavioral: S.A.M.B.A.

Interventions

S.A.M.B.A. BEHAVIORAL

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.

S.A.M.B.A. - Lifestyle Education Program

RICORDO DEVICE

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.

RICORDO - Digital Cognitive Rehabilitation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Giovanna Zamboni: lead
• IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan: collaborator

Study Sites (2)

Azienda Ospedaliero Universitaria di Modena

Modena, Reggio Nell'Emilia (RE), 42122, Italy

RECRUITING

IRCCS "S. Maria Nascente"

Milan, 20148, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Patient Participation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Giovanna Zamboni, M.D, PhD

CONTACT

+39 059/3962201; giovanna.zamboni@unimore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor of Neurology at the Department of Biomedical, Metabolic and Neural Sciences of the University of Modena and Reggio Emilia

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)