ADAI - Home Care in Intelligent Environments Clinical Care Ecosystem for the Management of Home Digital Therapies Through the Use of Assistive Robots and Clinical Predictive Systems Based on Artificial Intelligence Systems

NCT07566728 | Completed

• 2 other identifiers: ADAIAGILE srl
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Dementia is a neurocognitive disorder that causes a deterioration in cognitive function, significantly impacting social and work abilities and daily activities. Alzheimer's disease is diagnosed when cognitive decline affects at least two cognitive domains, one of which must involve memory. Mild Cognitive Impairment (MCI) is a critical diagnosis as it represents a potentially early stage of cognitive decline. In the DSM-5, MCI is defined as a "minor neurocognitive disorder," characterized by functional decline affecting at least one of six cognitive domains: memory and learning, language, visuospatial function, attention, executive function, and social functioning. It is important to emphasize that this decline is not severe enough to significantly impair the patient's daily activities. In this context, support for people with MCI and dementia is crucial, not only at the family and social level, but also through the adoption of innovative technological solutions. Artificial intelligence (AI) is emerging as a valuable tool for early diagnosis, and through machine learning processes, it is possible to predict cognitive decline, thus providing personalized treatment and day-to-day patient management. This allows for intervention at a less advanced stage of the disease, thus slowing its progression, while maintaining autonomy and independence for as long as possible, which tends to decline over time in this patient population. Investing in innovative technologies is therefore essential not only to improve prevention and treatment opportunities but also to provide concrete support to caregivers, especially at a time when the aging population requires an increasingly structured and effective global response. The objectives of the study are as follows:

• The objective of this study is to evaluate the effectiveness of software in administering cognitive and motor tests via a humanoid robot in patients with early-stage Alzheimer's disease (AD) or other forms of mild to moderate dementia.
• Support medical professionals in personalizing therapeutic treatments, using predictive models based on advanced artificial intelligence systems. These models will begin by collecting, monitoring, and processing demographic and clinical data and the results of cognitive and motor assessments obtained from patients to predict the course of the disease and the effectiveness of rehabilitation treatments. This will then allow them to suggest personalized treatment options and optimize care pathways, thus improving overall clinical outcomes.

Conditions

Neurodegenerative Disease; Artificial Intelligence (AI); Mild Cognitive Impairment (MCI)

Keywords

DEMENTIA; MILD COGNITIVE IMPAIRMENT; ARTIFICIAL INTELLIGENCE; DIGITAL THERAPEUTICS

Outcome Measures

Primary Outcomes (1)

• Mini Mental State Examination (MMSE) total score

  The MMSE will be administered through a humanoid robot interface. The total score (range 0-30) will be recorded, and mean scores and/or change from baseline will be analyzed. The aim of this study is therefore to evaluate the effectiveness of the software in administering MMSE via a humanoid robot in patients with early-stage Alzheimer's dementia (AD) or other forms of mild to moderate dementia.

  Through study completion, an average of 1 year

Study Arms (1)

early-stage AD or other forms of mild to moderate dementia who interact with the robot

EXPERIMENTAL

The study aims to test the effectiveness of an innovative digital solution on a cohort of subjects with early-stage AD or other forms of mild to moderate dementia. Patients with early-stage Alzheimer's disease and/or other forms of dementia will be recruited from the neurology and neurodegenerative disease outpatient clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina. The variables that will be considered are: (i) demographic data (age, gender, education level); (ii) clinical data relating to the patient's health status, such as the presence of risk factors for neurodegenerative diseases such as hypertension, diabetes, dyslipidemia, heart disease, carotid stenosis, atrial fibrillation, and heredity and smoking; (iii) data relating to the ability to perform basic and instrumental activities of daily living and mood. The data will be recorded manually via tablet by the physician. After data collection, patients will undergo neuropsychological and motor tests.

Device: CLINICAL INVESTIGATION WITH A MEDICAL DEVICE MARKED CE

Interventions

CLINICAL INVESTIGATION WITH A MEDICAL DEVICE MARKED CE DEVICE

The proposed study is an interventional study that aims to test the effectiveness of an innovative digital solution on a cohort of subjects with early-stage AD or other forms of mild to moderate dementia. Patients with early-stage Alzheimer's disease and/or other forms of dementia will be recruited from the neurology and neurodegenerative disease outpatient clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina. The variables that will be considered are: (i) demographic data (age, gender, education level); (ii) clinical data relating to the patient's health status, such as the presence of risk factors for neurodegenerative diseases such as hypertension, diabetes, dyslipidemia, heart disease, carotid stenosis, atrial fibrillation, and heredity and smoking; (iii) data relating to the ability to perform basic and instrumental activities of daily living and mood. The data will be recorded manually via tablet by the physician. After data collection, patients will undergo

early-stage AD or other forms of mild to moderate dementia who interact with the robot

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 40 and 80
• Clinical Rating Scale (CDR) score \< 1
• Patients with moderate to mild cognitive impairment

You may not qualify if:

• Subjects with marked visual and hearing impairments that prevent proper understanding of the trial
• Patients with impaired language comprehension
• Patients with comorbid psychiatric disorders
• Lack of consent to participate by signing the informed consent form

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Messina, 98123, Italy

Location

MeSH Terms

Conditions

Neurodegenerative Diseases; Cognitive Dysfunction; Dementia

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study aims to test the effectiveness of an innovative digital solution on a cohort of subjects with early-stage AD or other forms of mild to moderate dementia. Patients with early-stage Alzheimer's disease and/or other forms of dementia will be recruited from the neurology and neurodegenerative disease outpatient clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina. The variables that will be considered are: (i) demographic data (age, gender, education level); (ii) clinical data relating to the patient's health status, such as the presence of risk factors for neurodegenerative diseases such as hypertension, diabetes, dyslipidemia, heart disease, carotid stenosis, atrial fibrillation, and heredity and smoking; (iii) data relating to the ability to perform basic and instrumental activities of daily living and mood. The data will be recorded manually via tablet by the physician. After data collection, patients will undergo neuropsychological and motor tests. Specifically, te

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: May 5, 2026
• Study Start: September 22, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 31, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: trials office of our institute or with a direct request to the PI of the study protocol

Locations

IT (1)