Robotic technologies to reduce apathy in dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Respiratory-gated auricular vagus nerve stimulation for apathy in Parkinson's disease

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.