NCT07064226 Validation of a Digital Intervention to Rehabilitate Cognitive Resources
| NCT ID | NCT07064226 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi ETS |
| Condition | Mild Cognitive Impairment (MCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2025-10-06 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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;
Contact & Investigator
Valeria Blasi, Medical Doctor
PRINCIPAL INVESTIGATOR
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Frequently Asked Questions
Who can join the NCT07064226 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Mild Cognitive Impairment (MCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07064226 currently recruiting?
Yes, NCT07064226 is actively recruiting participants. Contact the research team at vblasi@dongnocchi.it for enrollment information.
Where is the NCT07064226 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07064226 clinical trial?
NCT07064226 is sponsored by Fondazione Don Carlo Gnocchi ETS. The principal investigator is Valeria Blasi, Medical Doctor at IRCCS Fondazione Don Carlo Gnocchi ONLUS. The trial plans to enroll 102 participants.