Validation of a Digital Intervention to Rehabilitate Cognitive Resources

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

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.

Eligibility criteria

Qualifiers

Montreal Cognitive Assessment (MoCA) score > 17.79;

Clinical Dementia Rating (CDR) Scale score ≤ 1;

Education level > 3 years;

Age ≥ 65 years;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • RICORDO
  • Treatment as Usual (TAU)

Treatment groups

102 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Università Carlo Cattaneo , Castellanza

Collaborator

Astir s.r.l.

Collaborator