Validation of a Digital Intervention to Rehabilitate Cognitive Resources (MI-RICORDO)

Don Carlo Gnocchi Onlus Foundation

Status: Not yet enrolling

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

Treatments: Other: Treatment as Usual (TAU); Other: RICORDO

Study type: Interventional

Funder types: Other

Identifiers

NCT07064226

MI-RICORDO

FP-1321 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

RICORDO

Experimental group

Description:

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

Treatment:

Other: RICORDO

Treatment as Usual (TAU)

Active Comparator group

Description:

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

Treatment:

Other: Treatment as Usual (TAU)