Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT07404410

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

Led by Giovanna Zamboni · Updated on 2026-05-05

75

Participants Needed

2

Research Sites

30 weeks

Total Duration

On this page

Sponsors

G

Giovanna Zamboni

Lead Sponsor

U

University of Genova

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40 years or older
  • Diagnosed with mild cognitive impairment, mild behavioral impairment, or dementia due to Alzheimer's disease, frontotemporal dementia, dementia with Lewy bodies, or other neurodegenerative diseases
  • Clinically relevant apathy with a score greater than 2 on the apathy domain of the Neuropsychiatric Inventory (NPI)
  • Ability to understand and produce spoken and written language sufficient for participation
  • No significant agitation or aggressiveness (score lower than 2 on agitation/aggression domain of NPI)
  • Adequate educational and occupational history to exclude intellectual disability
  • Availability of a study partner who knows the participant well, has at least 10 hours weekly contact, can complete questionnaires, understands Italian, and consents to participation
  • Participant and study partner able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Refusal or withdrawal of informed consent by participant or study partner
  • History or current neurological conditions other than target neurodegenerative diseases affecting cognition (e.g., major stroke, brain tumor, hydrocephalus, traumatic brain injury)
  • History or current major psychiatric disorders interfering with participation or assessments
  • Medical conditions significantly affecting cognition (e.g., severe kidney or liver failure, untreated sleep apnea, hypothyroidism, vitamin B12 deficiency)
  • Significant agitation or aggressiveness (score 2 or higher on agitation/aggression domain of NPI)
  • Inability to understand or communicate in Italian sufficiently for study procedures
  • Absence of an eligible study partner or withdrawal of study partner consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

IRCCS "S. Maria Nascente"

Milan, Italy, Italy, 20148

Actively Recruiting

2

Azienda Ospedaliero Universitaria di Modena

Modena, Italy, Italy, 41126

Actively Recruiting

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Research Team

G

Giovanna Zamboni, MD, DPhil

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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