Validation of a Digital Intervention to Rehabilitate Cognitive Resources

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

Interventions

OTHER

RICORDO

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.

OTHER

Treatment as Usual (TAU)

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.

Sponsors & Collaborators

• Università Carlo Cattaneo , Castellanza

  collaborator UNKNOWN

• ASTIR

  collaborator UNKNOWN

• Fondazione Don Carlo Gnocchi Onlus

  lead OTHER

Principal Investigators

• Valeria Blasi, Medical Doctor · IRCCS Fondazione Don Carlo Gnocchi ONLUS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-06

Primary Completion

2027-08-31

Completion

2027-09-30

Countries

• Italy

Study Locations