Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorGiovanna Zamboni

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: RICORDO - Digital Cognitive RehabilitationExperimental treatment 1 intervention
Group B: S.A.M.B.A. - Lifestyle Education ProgramActive comparator 1 intervention

Trial outcomes

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).

Time frame
Baseline (T0) and 5 weeks (T1)

Secondary outcomes

1

Montreal Cognitive Assessment

The MoCA is a brief cognitive screening tool used to detect mild cognitive impairment. It assesses multiple domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, abstract reasoning, calculation, and orientation. The test takes approximately 10 minutes to administer and has a maximum score of 30 points; scores of 26 or above are generally considered within the normal range. Tasks include the Trail Making Test, complex figure copying, object naming, word and sentence repetition, attention and verbal fluency tests, abstraction, and orientation questions. Each item is scored according to standardized criteria, allowing for reliable evaluation of a participant's cognitive performance.

Time frame
Baseline (T0) and 5 weeks (T1)
2

Cognitive Reserve Index questionnaire

The CRIq is a psychometric tool designed to assess the cumulative cognitive reserve developed across the lifespan. It evaluates three main domains: education, working activity, and leisure time, and provides an overall composite score of an individual's cognitive reserve. The CRIq is widely used in clinical and neuropsychological research to investigate the protective role of cognitive reserve in age-related cognitive decline and neurodegenerative diseases. Due to its simplicity, reliability, and validity, it is considered a useful tool in both clinical and epidemiological settings.

Time frame
Baseline (T0) only
3

World Health Organization Disability Assessment Schedule 2.0

The WHODAS 2.0 is a standardized, cross-culturally applicable instrument developed by the World Health Organization to assess health and disability in the general adult population and in clinical settings. WHODAS 2.0 assesses functioning across six key domains: cognition, mobility, self-care, social interaction, daily activities, and participation in society. Grounded in the framework of the International Classification of Functioning, Disability and Health (ICF), it measures health and disability as a continuum, regardless of the underlying medical condition. WHODAS 2.0 is available in two main versions-a 36-item full form and a 12-item short form-administered via interview, self-report, or proxy. It provides a composite score reflecting the functional impact of different health conditions and supports monitoring and planning of healthcare interventions.

Time frame
Baseline (T0) and 5 weeks (T1)
4

EuroQol-5 Dimension

The EQ-5D-5L is a standardized and quick-to-administer instrument designed to assess health-related quality of life (HRQL) from the patient's perspective. It evaluates five key dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated across five severity levels, generating up to 3,125 unique health states and providing a detailed picture of an individual's health status. The EQ-5D-5L also includes a visual analogue scale (VAS) ranging from 0 (the worst imaginable health state) to 100 (the best imaginable health state), allowing patients to provide a global rating of their perceived health. Due to its simplicity and versatility, it is widely used in clinical practice, economic evaluations, and epidemiological research, enabling comparisons across conditions and populations.

Time frame
Baseline (T0) and 5 weeks (T1)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Giovanna Zamboni

Lead sponsor

University of Modena and Reggio Emilia

Sponsor institution

IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan

Collaborator