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

Apathy is one of the most common behavioral symptoms associated with neurodegenerative disorders, including mild cognitive impairment (MCI) and dementia. It is characterized by diminished motivation, reduced initiation of activities, emotional blunting, and decreased social engagement. Apathy is associated with faster functional decline, reduced quality of life, increased caregiver burden, and limited response to currently available pharmacological treatments. For these reasons, non-pharmacological interventions are considered a priority target for clinical research.

This randomized controlled trial investigates the effectiveness of two home-based robotic interventions compared with standard occupational therapy for the management of apathy in individuals with cognitive decline. The study is conducted within a multi-center academic and clinical framework and follows international standards for interventional research, including SPIRIT recommendations and Good Clinical Practice principles.

The study adopts a single-blind, three-arm randomized design. Participants are randomly assigned in a 1:1:1 ratio to one of two experimental robot-based interventions or to an active control intervention consisting of home-based occupational therapy. Outcome assessments are performed by evaluators who are blinded to treatment allocation, while participants and intervention providers are aware of the assigned intervention due to the nature of the study.

The first experimental intervention uses a telepresence robotic system operated remotely by a trained researcher or therapist. Through this system, participants receive structured and personalized cognitive stimulation sessions delivered at home. The intervention protocol is based on evidence-supported cognitive rehabilitation programs and includes multiple weekly sessions over a six-week period. The telepresence robot enables real-time audiovisual interaction while allowing the operator to navigate the home environment, supporting engagement and continuity of care.

The second experimental intervention involves a social humanoid robot deployed in the participant's home. The robot is connected to a dedicated conversational server that enables personalized verbal and non-verbal interactions. The system adapts conversations to the participant's interests, personal history, and interaction patterns. Interactions may be initiated by the participant or proactively by the robot, with the aim of stimulating conversational initiative, social engagement, and sustained attention. The frequency and duration of interactions are flexible within the predefined intervention period, allowing the intervention to integrate into daily routines.

The active control intervention consists of a structured home-based occupational therapy program targeting behavioral symptoms. This intervention focuses on meaningful activities, environmental adaptations, caregiver education, and strategies to support participation and motivation in daily life. The occupational therapy protocol reflects current standards of care and is delivered over the same six-week timeframe as the experimental interventions.

All interventions are conducted in the participant's home environment to maximize ecological validity and generalization of effects. Where needed, technical support such as internet connectivity is provided to ensure consistent delivery of robot-based interventions. Participants and caregivers receive instruction on the use of devices, and safety procedures are implemented throughout the intervention period.

Assessments are conducted at baseline, immediately after the six-week intervention, and at follow-up six weeks after the end of treatment. These assessments include standardized clinical scales, behavioral tasks, and caregiver-reported measures. In addition, sensor-based and interaction-derived data are collected during selected tasks and robot interactions to explore digital markers of apathy and engagement. These data include measures related to movement kinematics, interaction frequency, conversational dynamics, and system usability.

Data are pseudonymized and stored in a secure electronic data capture system accessible only to authorized research personnel. Each participating center acts as an independent data controller for data collected locally, while centralized data management supports harmonization and analysis. All data handling procedures comply with applicable data protection regulations.

The primary aim of the study is to determine whether robotic interventions provide added value over standard occupational therapy in reducing apathy in people with cognitive impairment. Secondary aims include evaluating usability, feasibility, caregiver-related outcomes, and the relationship between clinical measures and digitally derived behavioral indicators.

By combining clinical assessments with advanced robotic technologies, this study seeks to generate evidence on innovative, scalable, and home-based approaches to the management of apathy. The findings are expected to inform future clinical practice and support the development of digital and robotic solutions for non-pharmacological treatment in neurodegenerative conditions.

Inclusion criteria

• Age 40 years or older
• Clinical diagnosis of a neurocognitive disorder, including: Mild cognitive impairment (MCI) or mild behavioral impairment (MBI), or Major neurocognitive disorder (dementia), due to Alzheimer's disease, frontotemporal dementia, dementia with Lewy bodies, or other neurodegenerative diseases.
• Presence of clinically relevant apathy, defined as a score greater than 2 on the apathy domain (G) of the Neuropsychiatric Inventory (NPI).
• Preserved ability to understand and produce spoken and written language sufficient to participate in the intervention and assessments.
• Absence of clinically significant agitation or aggressiveness, defined as a score lower than 2 on the agitation/aggression domain (C) of the NPI.
• Adequate educational and occupational history sufficient to exclude intellectual disability.
• Availability of a study partner (family member, friend, or caregiver) who: Knows the participant well, Has contact with the participant for at least 10 hours per week, Is able to complete questionnaires about the participant, Is able to read, understand, and speak Italian, and Provides independent informed consent for participation.
• Ability and willingness of the participant (and study partner, when applicable) to provide informed consent.

Exclusion criteria

• Refusal or withdrawal of informed consent by the participant or the study partner.
• History or current evidence of neurological conditions other than the target neurodegenerative diseases that may affect cognitive function (e.g., major stroke, brain tumor, normal pressure hydrocephalus, traumatic brain injury).
• History or current diagnosis of major psychiatric disorders that could interfere with study participation or assessments.
• Presence of medical conditions that may significantly affect cognitive function (e.g., severe renal or hepatic failure, untreated obstructive sleep apnea, hypothyroidism, vitamin B12 deficiency).
• Clinically significant agitation or aggressiveness, defined as a score of 2 or higher on the agitation/aggression domain (C) of the Neuropsychiatric Inventory (NPI).
• Inability to understand or communicate in Italian sufficient to complete study procedures.
• Absence of an eligible study partner or withdrawal of consent by the study partner.