Validation of a Digital Intervention to Rehabilitate Cognitive Resources

NCT07064226 | Recruiting

• 2 other identifiers: MI-RICORDOFP-1321
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the use of a digital cognitive rehabilitation system named RICORDO, that is flexible and capable of adapting the rehabilitation pathway according to the needs and capacity of the patients will prove effective for subjects with Subjective Memory Complaint or with Mild Cognitive Impairment or with Mild Dementia. The main questions it aims to answer are: Will the RICORDO rehabilitation treatment, lead to an improvement in the global cognitive level? Will the RICORDO rehabilitation treatment lead to improved activation of participants in managing their own health and healthcare? Researchers will compare the multidomain cognitive rehabilitation strategy of RICORDO digital solution, with a standard paper pencil rehabilitation care (usual care). Participants will undergo a comprehensive neuropsychological evaluation immediately before, immediately after and six months after the completion of the rehabilitation program. Both interventions, the experimental and the usual care, will last 5 weeks, with 3 weekly sessions of 45 minutes each and can be done autonomously by the patient at home.

Conditions

Mild Cognitive Impairment (MCI); Subjective Memory Complaint; Dementia Alzheimer Type

Keywords

telerehabilitation; Alzheimer disease; cognitive decline; cognitive rehabilitation; Digital medicine; Dementia; Mild Cognitive Impairment; neuroimaging

Outcome Measures

Primary Outcomes (2)

• Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment MoCA

  MoCA is a screening test for cognitive deficits. It measures the global cognitive functioning and includes several tasks involving different domains: visuospatial/executive function, language, selective and sustained attention, abstraction, memory and orientation. Score ranges from 0 to 30 with higher scores indicating better general cognitive performance.

  Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)

• Change in Activation level of Patients measured by Patient Activation Measure 13 (PAM13)

  The Patient Activation Measure (PAM-13) is a 13-item instrument designed to evaluate an individual's knowledge, skills, and confidence in effectively managing their health and healthcare. The total PAM-13 score ranges from 0 to 100, with higher scores indicating greater levels of activation and more favorable outcomes. Individuals classified in the lowest activation level typically lack awareness of their role in managing their health, demonstrate limited health-related knowledge, and possess underdeveloped self-management abilities. In contrast, those in the highest activation level exhibit proactive health behaviors, possess well-established self-management competencies, and demonstrate resilience in response to stress or health-related changes.

  Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)

Secondary Outcomes (11)

• Change in memory in everyday situations measured by Everyday Memory Questionnaire Revised

  Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)

• Change in depressive symptoms measured by Beck Depression Inventory II

  Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)

• Change in mood measured by Positive and Negative Affect Scale (PANAS)

  Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)

• Change in anxiety level measured by State-Trait Anxiety Inventory (STAI- Y state)

  Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)

• Change in Language and Executive Functions evaluated by Phonemic/Semantic alternate fluency test

  Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)

Other Outcomes (2)

• Changes in Fractional Anisotropy (FA) and Mean Diffusivity (MD) as detected by Diffusion Weighted Magnetic Resonance Imaging (DWI).

  Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)

• Changes in Functional Connectivity (FC) as detected by resting state functional Magnetic Resonance Imaging (rs-fMRI)

  Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)

Study Arms (2)

RICORDO

EXPERIMENTAL

Participants will carry out telerehabilitation using a digital platform \[http://www.ricordo-dtx.com/\], at home, autonomously.

Other: RICORDO

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants will follow a traditional paper-and-pencil rehabilitation protocol at home, autonomously.

Other: Treatment as Usual (TAU)

Interventions

RICORDO OTHER

During the RICORDO intervention, participants will engage in a multidomain cognitive telerehabilitation program using a digital platform (\[http://www.ricordo-dtx.com/\]), which allows for personalized interventions through an adaptive algorithm allowing an increment in task difficulties according to patients' needs. The treatment can be self-administered by the patient at home. The program lasts five weeks, with three treatment sessions per week, each lasting approximately 45 minutes. The active control group (TAU) will undergo the same type of treatment with the following differences: the digital platform will not be used, as the treatment will consist solely of paper-and-pencil exercises; and there will be no personalization of the exercises, since automatic adaptation is not possible.

RICORDO

Treatment as Usual (TAU) OTHER

As described above, this type of intervention will consist in a multidomain cognitive rehabilitation treatment to be self administered by the participants at home with pencil paper excercises. Treatment will last 5 weeks, 3 sessions per week, each lasting approximately 45 minutes. The treatment will follow a predefined incremental difficulty structure since no personalization is available.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Montreal Cognitive Assessment (MoCA) score \> 17.79;
• Clinical Dementia Rating (CDR) Scale score ≤ 1;
• Education level \> 3 years;
• Age ≥ 65 years;
• Informed consent to participate, confirmed by signing the consent form;
• Availability of a caregiver/study partner able to support the participant;
• Stable pharmacological treatment (past 3 months) with acetylcholinesterase inhibitors, if applicable.

You may not qualify if:

• Presence of dysmetria or marked auditory/visual or communication disorders preventing the participation to the trial;
• Presence of ongoing rehabilitation program at the time of enrollment or in the 3 months prior to enrollment;

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Università Carlo Cattaneo , Castellanza: collaborator
• ASTIR: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi ONLUS; Center of Advance Diagnostic and Therapy ( CADiTeR)

Milan, 20148, Italy

RECRUITING

Related Publications (14)

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  BACKGROUND

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  PMID: 21029744 BACKGROUND

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  PMID: 23963806 BACKGROUND

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• Royle J, Lincoln NB. The Everyday Memory Questionnaire-revised: development of a 13-item scale. Disabil Rehabil. 2008;30(2):114-21. doi: 10.1080/09638280701223876.

  PMID: 17852284 BACKGROUND

• Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.

  PMID: 15230939 BACKGROUND

• Dapor C, Devita M, Iannizzi P, Arbia E, Bruzzano A, Dessi M, Lupi D, Rolandino GM, Rossi M, Saccomano A, Siccardi E, Simonetto A, Vuerich G, Zuliani S, Priftis K. The Montreal cognitive assessment (MoCA) 8.1 version, including the memory index score (MoCA-MIS): Italian norms. Neurol Sci. 2025 Jun;46(6):2581-2589. doi: 10.1007/s10072-025-08066-1. Epub 2025 Mar 17.

  PMID: 40095163 BACKGROUND

• Blasi V, Isernia S, Rossetto F, Pagliari C, Borgnis F, Pirastru A, Marzulli M, Foglia E, Garagiola E, Baglio F. Study protocol for a randomized controlled trial assessing clinical efficacy of digital cognitive rehabilitation for preclinical and mild clinical stages of alzheimer's disease continuum: the MI-RICORDO project. BMC Psychiatry. 2025 Nov 11;25(1):1075. doi: 10.1186/s12888-025-07531-7.

  PMID: 41219714 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Valeria Blasi, Medical Doctor

  IRCCS Fondazione Don Carlo Gnocchi ONLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valeria Blasi, MD

CONTACT

+390240308952; vblasi@dongnocchi.it

Chiara Pagliari, PhD

CONTACT

+390240308952; cpagliari@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control study with 2 groups: experimental rehabilitation intervention (Ricordo) vs Treatment as usual

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)