ApathyRAPHAelNCT07404410
Robotic Technologies for APATHy in Dementia: a Randomised Controlled Trial (RAPHAel)
A study testing telepresence robotic system, Pepper robot connected to a CAIR server and Occupational Therapy in people with Apathy and Apathy in Dementia, run by Giovanna Zamboni at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Apathy, Apathy in Dementia
- What is being tested?
- telepresence robotic system, Pepper robot connected to a CAIR server and Occupational Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesItaly
- Study dates
- 28 Apr 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS "S. Maria Nascente"
Milan, Italy, 20148
Francesca Baglio, MD, PhD, +39 338 320 5593, fbaglio@dongnocchi.it
- Recruiting
Azienda Ospedaliero Universitaria di Modena
Modena, Italy, 41126
Giovanna Zamboni, MD, DPhil, 3665306279, giovanna.zamboni@unimore.it
Francesca Benuzzi, PhD
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Apathy, Apathy in Dementia
- Being tested
- telepresence robotic system, Pepper robot connected to a CAIR server, Occupational Therapy
- Keywords
- dementia, apathy, robotics
- Medical subject headings
- Lethargy, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telepresence robotic systemDevice
Also called telerobot
The telepresence robot is designed to enable high-quality remote interaction through high-definition video streaming, clear two-way audio, and intuitive mobile navigation. It allows a therapist to connect in real time with a participant at home, moving within the environment and interacting as if physically present. In the RAPHAEL study, the telerobot is used by an occupational therapist to deliver personalized home-based sessions, guiding participants through exercises and activities via video calls conducted from the therapist's own device. The robot operates according to the manufacturer's intended use and user manual. Its modular hardware and software, reliability, and ease of use support consistent delivery of intervention sessions. The telerobot is already widely used in healthcare, education, and professional settings in more than 30 countries, making it a well-established platform for remote clinical interaction and support.
Pepper robot connected to a CAIR serverDevice
Also called social robot, talking robot, culturally sensitive robot
The intervention is based on an integrated robotic system designed to support personalized social interaction at home. It includes a commercial humanoid robot (Pepper) used as a physical interaction platform, supported by a local computer server and a Wi-Fi router with 4G connectivity to ensure stable operation. The core of the intervention is a dedicated software medical device (Server CAIR), which manages and adapts the interaction logic. A client application running on the robot enables verbal and non-verbal communication with the participant, while a separate software interface allows researchers to personalize content based on individual preferences and history. Speech recognition and language processing are supported by third-party services for voice transcription and response generation. Together, these components enable adaptive, conversational interactions aimed at stimulating engagement and social participation in a home setting.
Occupational TherapyBehavioural
Also called OT, standard of care
Human-based intervention delivered through an occupational therapy program focused on the prevention and management of behavioral symptoms, conducted by an occupational therapist in accordance with Essential Levels of Care (LEA). The techniques and protocols aim to prevent, reduce, and manage BPSD, train the caregiver, and improve quality of life for both the individual and the caregiver. The intervention includes 8 home visits and 2 telephone sessions over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| telepresence robot | Experimental | 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. Receives: Behavioral: Occupational Therapy |
| social robot | Experimental | 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. Receives: Device: Pepper robot connected to a CAIR server |
| occupational therapy | Active comparator | 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. Receives: Device: telepresence robotic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in apathy severity
Change in apathy severity measured by the Apathy Evaluation Scale (AES) total score, assessed from baseline (T0) to end of intervention at 6 weeks (T1).
Measured: Baseline to 6 weeks
Secondary outcomes (3)
Caregiver burden
Change in caregiver burden measured by the Zarit Burden Inventory (ZBI) total score.
Measured: Baseline, 6 weeks
caregiver quality of life
Change in caregiver quality of life measured by the Quality of Life-Alzheimer's Disease (QoL-AD) caregiver version
Measured: Baseline, 6 weeks
social cognition
Change in social cognition performance measured by the Yoni-48 task and the Edinburgh Social Cognition Test (ESCoT).
Measured: 0 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start28 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giovanna Zamboni
- Sponsor type
- University, hospital or other
- Collaborators
- University of Genova, Fondazione Don Carlo Gnocchi ETS, University of Florence
- Responsible party
- Sponsor-investigator, Giovanna Zamboni, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404410
- Sponsor's protocol ID
- 263/2024/DISP/AOUMO
- Acronym
- RAPHAel
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Technologies for APATHy in Dementia: a Randomised Controlled Trial (RAPHAel)
- ClinicalTrials.gov ID
- NCT07404410
- Acronym / sponsor ID
- RAPHAel / 263/2024/DISP/AOUMO
- Conditions
- Apathy, Apathy in Dementia
- Keywords
- dementia, apathy, robotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Giovanna ZamboniUniversity, hospital or other
- Collaborators
- University of Genova, Fondazione Don Carlo Gnocchi ETS, University of Florence
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| telepresence robot | Experimental | Behavioral: Occupational TherapyThe 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. |
| social robot | Experimental | Device: Pepper robot connected to a CAIR serverThe 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. |
| occupational therapy | Active comparator | Device: telepresence robotic systemThe 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telepresence robotic systemAlso: telerobotThe telepresence robot is designed to enable high-quality remote interaction through high-definition video streaming, clear two-way audio, and intuitive mobile navigation. It allows a therapist to connect in real time with a participant at home, moving within the environment and interacting as if physically present. In the RAPHAEL study, the telerobot is used by an occupational therapist to deliver personalized home-based sessions, guiding participants through exercises and activities via video calls conducted from the therapist's own device. The robot operates according to the manufacturer's intended use and user manual. Its modular hardware and software, reliability, and ease of use support consistent delivery of intervention sessions. The telerobot is already widely used in healthcare, education, and professional settings in more than 30 countries, making it a well-established platform for remote clinical interaction and support. | Device | occupational therapy |
| Pepper robot connected to a CAIR serverAlso: social robot, talking robot, culturally sensitive robotThe intervention is based on an integrated robotic system designed to support personalized social interaction at home. It includes a commercial humanoid robot (Pepper) used as a physical interaction platform, supported by a local computer server and a Wi-Fi router with 4G connectivity to ensure stable operation. The core of the intervention is a dedicated software medical device (Server CAIR), which manages and adapts the interaction logic. A client application running on the robot enables verbal and non-verbal communication with the participant, while a separate software interface allows researchers to personalize content based on individual preferences and history. Speech recognition and language processing are supported by third-party services for voice transcription and response generation. Together, these components enable adaptive, conversational interactions aimed at stimulating engagement and social participation in a home setting. | Device | social robot |
| Occupational TherapyAlso: OT, standard of careHuman-based intervention delivered through an occupational therapy program focused on the prevention and management of behavioral symptoms, conducted by an occupational therapist in accordance with Essential Levels of Care (LEA). The techniques and protocols aim to prevent, reduce, and manage BPSD, train the caregiver, and improve quality of life for both the individual and the caregiver. The intervention includes 8 home visits and 2 telephone sessions over 6 weeks. | Behavioural | telepresence robot |
Primary outcome
Change in apathy severity
Time frame: Baseline to 6 weeks
Change in apathy severity measured by the Apathy Evaluation Scale (AES) total score, assessed from baseline (T0) to end of intervention at 6 weeks (T1).
3 secondary outcomes
Caregiver burden
Time frame: Baseline, 6 weeks
caregiver quality of life
Time frame: Baseline, 6 weeks
social cognition
Time frame: 0 to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telepresence robotic system, Pepper robot connected to a CAIR server and Occupational Therapy in people with Apathy and Apathy in Dementia, run by Giovanna Zamboni at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanna Zamboni, MD, DPhil (+393665306279, giovanna.zamboni@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apathy severity (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.