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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this trial is to learn whether home-based robotic interventions can reduce apathy in people with cognitive decline. Apathy means reduced motivation, interest, or initiative in daily life. It is a common and distressing symptom in people with mild cognitive impairment (MCI) or dementia and can strongly affect both participants and their caregivers. This study will compare two different robotic interventions with standard occupational therapy. Researchers want to understand if these new technologies can help people become more engaged, motivated, and involved in everyday activities, and whether they also reduce stress and improve quality of life for caregivers. The main questions this study aims to answer are: * Do robotic interventions reduce apathy more than standard occupational therapy? * Are these robotic interventions easy to use and acceptable for people with cognitive impairment? * Do these interventions reduce caregiver stress and improve caregiver quality of life? Participants will be adults over 40 years of age with a diagnosis of mild cognitive impairment or dementia caused by a neurodegenerative disease, such as Alzheimer's disease, frontotemporal dementia, or dementia with Lewy bodies. All participants must show clinically relevant apathy and have a family member or caregiver who can support them during the study and answer questionnaires. Participants will be randomly assigned to one of three groups: * A telepresence robot group, where participants interact at home with a therapist through a remotely controlled robot that delivers personalized cognitive stimulation. * A social robot group, where participants interact at home with a humanoid robot that holds personalized conversations on topics of interest. * A control group receiving home-based occupational therapy, which is the current standard care for behavioral symptoms. Each intervention lasts six weeks and takes place in the participant's home. The robotic interventions are designed to fit into daily routines and can be adapted to the participant's abilities and preferences. Occupational therapy sessions focus on meaningful activities, environmental adaptations, and caregiver support. Participants will complete assessments at three time points: before the intervention, at the end of the six-week intervention, and eight weeks after the intervention ends. These assessments include interviews, questionnaires, and simple tasks to measure apathy, emotional responses, social interaction, and quality of life. Caregivers will also complete questionnaires about stress and daily burden. Researchers will also collect information about how often and how participants interact with the robots, such as how long conversations last and how engaged participants appear. These data will help researchers understand how robotic interactions relate to changes in apathy and behavior. This study aims to provide evidence on whether robotic technologies can be safely and effectively used at home to support people with cognitive impairment and apathy. The results may help develop new non-drug treatments and improve care options for people living with dementia and their caregivers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS S. Maria Nascente
RECRUITING
Milan
Azienda Ospedaliero Universitaria di Modena
RECRUITING
Modena
Contact Information
Primary
Giovanna Zamboni, MD, DPhil
giovanna.zamboni@unimore.it
+393665306279
Time Frame
Start Date: 2026-04-28
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 75
Treatments
Experimental: telepresence robot
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.
Experimental: social robot
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.
Active_comparator: occupational therapy
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.
Sponsors
Collaborators: Fondazione Don Carlo Gnocchi Onlus, University of Genova, University of Florence
Leads: Giovanna Zamboni

This content was sourced from clinicaltrials.gov

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