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
Trial ID: NCT07566728
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-09-22
Completion date: 2025-10-31
Sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Conditions: Neurodegenerative Disease; Artificial Intelligence (AI); Mild Cognitive Impairment (MCI)
Interventions: CLINICAL INVESTIGATION WITH A MEDICAL DEVICE MARKED CE
Locations: IRCCS Centro Neurolesi Bonino Pulejo
Countries: Italy
Enrollment: 23
Age range: 40 Years - 80 Years
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

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

Exclusion Criteria:

* 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

Outcomes:
Mini Mental State Examination (MMSE) total score