Robot companions take on dementia apathy: a new hope for caregivers?
NCT ID NCT07404410
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using robots at home can reduce apathy—loss of motivation and interest—in people with mild cognitive impairment or dementia. About 75 adults over 40 with apathy will be randomly assigned to interact with a telepresence robot, a social robot, or receive standard occupational therapy. The goal is to see if robotic interactions boost engagement and ease caregiver stress.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Ospedaliero Universitaria di Modena
RECRUITINGModena, Italy, 41126, Italy
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IRCCS "S. Maria Nascente"
RECRUITINGMilan, Italy, 20148, Italy
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