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Validation of a Digital Intervention to Rehabilitate Cognitive Resources

Validation of a Digital Intervention to Rehabilitate Cognitive Resources

Recruiting
65 years and older
All
Phase N/A

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Overview

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

Inclusion Criteria:

Cases

  • Age ≥18 years.
  • CKD.
  • Suspicion of calciphylaxis or newly diagnosed calciphylaxis episode. The suspicion or diagnosis of calciphylaxis is a mutual decision of the involved medical specialties (nephrologist, dermatologist, pathologist, other).
  • Ability to give informed consent.
  • Ability to participate in a clinical study as assessed by the local investigator.
  • Provides written informed consent.

Controls

  • Age ≥18 years.
  • CKD
  • Ability to give informed consent.
  • Ability to participate in a clinical study as assessed by the local investigator.
  • Provides written informed consent.

Healthy reference group

  • Age ≥18 years.
  • Self-assessed as healthy, confirmed by local investigators at inclusion

Exclusion Criteria:

Cases

\- the calciphylaxis diagnosis becomes excluded

Controls - Being diagnosed with calciphylaxis

Healthy controls Up to 60 years of age: eGFR below 60 ml/min/1.72m2.

\- Over 60 years of age: eGFR below the 95% confidence interval for eGFR adjusted for age (Danish Society of Nephrology references ranges)

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

NCT07064226

Fondazione Don Carlo Gnocchi Onlus

13 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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