Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT07286448
Recruiting Not applicable

Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment

NCT07286448 · tracked via the Priya Life Science Italy tracker
Sponsor
Giovanna Zamboni
Phase
Not applicable
Started
2025-11-28
Last updated
2026-04-29

Condition(s) studied

Mild Cognitive Impairment (MCI)Subjective Cognitive Decline (SCD)

Investigational drug(s) / intervention(s)

RICORDOS.A.M.B.A.

RICORDO: RICORDO is a CE-marked digital therapeutic for cognitive rehabilitation, delivered via tablet. The program consists of home-based sessions, each lasting approximately 45 minutes. Tasks are automatically adapted based on the participant's baseline cognitive profile and real-time performance. Clinicians remotely monitor adherence and adjust the prescription through a web platform.

S.A.M.B.A.: S.A.M.B.A. (Socialisation, Alimentazione, Movimento, Benessere psicologico, Ambiente) is a structured, home-based lifestyle education program. Participants receive printed and video materials and complete sessions covering key domains of brain-healthy behavior. This arm is matched in duration and frequency to the experimental arm but includes no cognitive training.

Study summary

The goal of this clinical trial is to determine whether a home-based digital cognitive-training program called RICORDO can enhance patients' ability to manage their own health and daily life when they have Mild Cognitive Impairment (MCI) or Subjective Cognitive Decline (SCD) and are 50 years of age or older.

The main questions it aims to answer are:

Does using RICORDO for five weeks raise the Patient Activation Measure (PAM) score more than an at-home paper-and-video education program called S.A.M.B.A.?

Does RICORDO also improve cognition, everyday functioning, quality of life and mood compared with S.A.M.B.A.?

Researchers will compare individuals who train with RICORDO to those who follow S.A.M.B.A. to determine which approach is more effective.

Participants will be randomly assigned to one of the two groups and complete three 45-minute sessions per week at home for five weeks. They will also visit the clinic at the beginning and end of the program to complete questionnaires and take brief thinking tests.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of Mild Cognitive Impairment (MCI) based on Petersen (1999) and Winblad (2004), or Subjective Cognitive Decline (SCD) according to Jessen (2014) * Mini-Mental State Examination (MMSE) \> 18 and Clinical Dementia Rating (CDR) ≤ 1 * Age ≥ 50 years * Formal education \> 3 years * Signed informed consent * Stable neurotropic pharmacological therapy in the past 3 months (if applicable) * Preserved mental capacity (i.e., not under legal guardianship or protective supervision) * Preserved ability to understand and produce written and spoken Italian Exclusion Criteria: * Severe sensory or communication impairments * Recent participation (\< 3 months) in cognitive or rehabilitation programs * Failure to provide or withdrawal of informed consent * History or evidence of central nervous system disorders that may affect cognition and are unrelated to the study (e.g., major stroke, brain tumors, normal pressure hydrocephalus, traumatic brain injury) * History or evidence of major psychiatric disorders * Presence of medical conditions that may interfere with cognitive function (e.g., renal or hepatic failure, obstructive sleep apnea, hypothyroidism, vitamin B12 deficiency)

Primary outcome measure(s)

  • Patient Activation Measure — Baseline (T0) and 5 weeks (T1)
    The Patient Activation Measure (PAM) is a validated and highly reliable scale designed to assess a person's level of activation, defined as their ability to manage their own health and actively participate in care. The PAM identifies four progressive levels of activation: (1) awareness of the importance of one's role in managing health, (2) acquisition of the knowledge and confidence to take action, (3) initiation of health-related behaviors, and (4) consistent maintenance of those behaviors even under stress (Hibbard et al., 2004).

Trial sites (2)

FacilityCityRegionStatus
Azienda Ospedaliero Universitaria di Modena Modena Reggio Nell'Emilia (RE) Recruiting
IRCCS "S. Maria Nascente" Milan Italy Recruiting

More Giovanna Zamboni trials in Italy

Robotic Technologies for APATHy in Dementia: a Randomised Controlled Trial (RAPHAel) Recruiting

Other trials for the same condition

Exercises for Rehabilitation of COgnition and Lifestyle Enhancement in Patients With Mild Cognitive Impairment Recruiting
InRAD Observational Study Recruiting
A Multifocal tDCS-EEG Protocol for Improving Symptoms of Mild Cognitive Impairment and Early Dementia Recruiting
Digital Solutions for Predicting the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors Recruiting
Italian Validation of the dNA Scale and Its Correlation With Neurocognitive Variables Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07286448 on ClinicalTrials.gov ↗ ← All trials in Italy