Robotic technologies to reduce apathy in dementia
Robotic Technologies for APATHy in Dementia: a Randomised Controlled Trial (RAPHAel)
This project will test whether two different home-based robotic programs can help people with mild cognitive impairment or dementia who have apathy become more motivated and engaged compared with standard occupational therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Modena and Reggio Emilia Academic / other |
| Locations | 2 sites (Milan, Italy and 1 other locations) |
| Trial ID | NCT07404410 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blind, three-arm trial compares two home-delivered robotic interventions (a telepresence system and a Pepper social robot connected to a CAIR server) with an active control of home-based occupational therapy, with participants randomized 1:1:1. Interventions are provided in participants' homes and outcome assessments are performed by evaluators blinded to allocation. Primary outcomes focus on changes in apathy, while secondary outcomes include usability and acceptability, caregiver stress, and caregiver quality of life. The trial is conducted across multiple Italian academic and clinical centers following international interventional research standards.
Who should consider this trial
Good fit: Ideal participants are adults aged 40 or older with mild cognitive impairment or mild dementia from a neurodegenerative disease, clinically relevant apathy (NPI apathy domain >2), preserved spoken and written language, low agitation (NPI agitation/aggression <2), and an available study partner.
Not a fit: Patients with advanced dementia, significant agitation or aggression, major language impairment, intellectual disability, or those without a reliable study partner or the ability to receive home visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these home-based robotic programs could reduce apathy, increase daily engagement, and ease caregiver stress as a non-drug option delivered at home.
How similar studies have performed: Small pilot studies of social and telepresence robots have shown improved engagement and feasibility, but robust randomized evidence that these approaches reduce apathy in dementia is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan, Italy and 1 other locations
- IRCCS "S. Maria Nascente" — Milan, Italy, Italy (Recruiting)
- Azienda Ospedaliero Universitaria di Modena — Modena, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanna Zamboni, MD, DPhil
- Email: giovanna.zamboni@unimore.it
- Phone: +393665306279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.