NCT07404410 · RECRUITING
Robotic Technologies for APATHy in Dementia: a Randomised Controlled Trial (RAPHAel)
This trial is testing whether two types of home robots — one that connects people to a therapist remotely, one that holds personalized conversations — can reduce apathy (loss of motivation and engagement) in people with MCI or dementia better than standard occupational therapy. It is a Phase NA randomized controlled trial, meaning it is a head-to-head comparison study focused on effectiveness and real-world usability, not early drug safety testing.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-05-05