BridgeMD
New treatment option for Apathy
Official title Robotic Technologies for APATHy in Dementia: a Randomised Controlled Trial (RAPHAel)
ClinicalTrials.gov ID: NCT07404410
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Age 40 years or older
- Clinical diagnosis of a neurocognitive disorder, including: Mild cognitive impairment (MCI) or mild behavioral impairment (MBI), or Major...
- 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.
You likely can't join 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...
- 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...
- Clinically significant agitation or aggressiveness, defined as a score of 2 or higher on the agitation/aggression domain (C) of the Neuropsychiatric...
- Inability to understand or communicate in Italian sufficient to complete study procedures.
See the full eligibility 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...
- 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...
- Ability and willingness of the participant (and study partner, when applicable) to provide informed consent.
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy, Italy
- Modena, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy, Italy; Modena, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.