[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Giovanna Zamboni\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100624036","robotic-technologies-for-apathy-in-dementia-a-randomised-controlled-trial-raphael-100624036",false,"NCT07404410","Robotic Technologies for APATHy in Dementia: a Randomised Controlled Trial (RAPHAel)","RAPHAel","Inclusion Criteria:\n\n* Age 40 years or older\n* 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.\n* Presence of clinically relevant apathy, defined as a score greater than 2 on the apathy domain (G) of the Neuropsychiatric Inventory (NPI).\n* Preserved ability to understand and produce spoken and written language sufficient to participate in the intervention and assessments.\n* Absence of clinically significant agitation or aggressiveness, defined as a score lower than 2 on the agitation\u002Faggression domain (C) of the NPI.\n* Adequate educational and occupational history sufficient to exclude intellectual disability.\n* 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.\n* Ability and willingness of the participant (and study partner, when applicable) to provide informed consent.\n\nExclusion criteria:\n\n* Refusal or withdrawal of informed consent by the participant or the study partner.\n* 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).\n* History or current diagnosis of major psychiatric disorders that could interfere with study participation or assessments.\n* 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).\n* Clinically significant agitation or aggressiveness, defined as a score of 2 or higher on the agitation\u002Faggression domain (C) of the Neuropsychiatric Inventory (NPI).\n* Inability to understand or communicate in Italian sufficient to complete study procedures.\n* Absence of an eligible study partner or withdrawal of consent by the study partner.","ALL","40 Years",{"count":19,"type":20},75,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.\n\nThis 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.\n\nThe main questions this study aims to answer are:\n\n* Do robotic interventions reduce apathy more than standard occupational therapy?\n* Are these robotic interventions easy to use and acceptable for people with cognitive impairment?\n* Do these interventions reduce caregiver stress and improve caregiver quality of life?\n\nParticipants 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.\n\nParticipants will be randomly assigned to one of three groups:\n\n* A telepresence robot group, where participants interact at home with a therapist through a remotely controlled robot that delivers personalized cognitive stimulation.\n* A social robot group, where participants interact at home with a humanoid robot that holds personalized conversations on topics of interest.\n* A control group receiving home-based occupational therapy, which is the current standard care for behavioral symptoms.\n\nEach 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.\n\nParticipants 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.\n\nResearchers 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.\n\nThis 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.",[26,27],"Apathy","Apathy in Dementia",[29,30,31],"dementia","apathy","robotics","RECRUITING","2026-04-28",{"date":35,"type":36},"2026-05-05","ACTUAL",{"date":33,"type":36},{"date":39,"type":20},"2026-11-30",{"name":41,"class":42},"Giovanna Zamboni","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":70,"locationsCount":5},"100614965","personalized-digital-training-for-cognitive-fitness-in-mild-cognitive-impairment-100614965","NCT07286448","Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment","Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment: the COG-FIT Pragmatic Trial","COG-FIT","Inclusion Criteria:\n\n* Diagnosis of Mild Cognitive Impairment (MCI) based on Petersen (1999) and Winblad (2004), or Subjective Cognitive Decline (SCD) according to Jessen (2014)\n* Mini-Mental State Examination (MMSE) \\> 18 and Clinical Dementia Rating (CDR) ≤ 1\n* Age ≥ 50 years\n* Formal education \\> 3 years\n* Signed informed consent\n* Stable neurotropic pharmacological therapy in the past 3 months (if applicable)\n* Preserved mental capacity (i.e., not under legal guardianship or protective supervision)\n* Preserved ability to understand and produce written and spoken Italian\n\nExclusion Criteria:\n\n* Severe sensory or communication impairments\n* Recent participation (\\\u003C 3 months) in cognitive or rehabilitation programs\n* Failure to provide or withdrawal of informed consent\n* History or evidence of central nervous system disorders that may affect cognition and are unrelated to the study (e.g., major stroke, brain tumors, normal pressure hydrocephalus, traumatic brain injury)\n* History or evidence of major psychiatric disorders\n* Presence of medical conditions that may interfere with cognitive function (e.g., renal or hepatic failure, obstructive sleep apnea, hypothyroidism, vitamin B12 deficiency)","50 Years",{"count":53,"type":20},100,[23],"The goal of this clinical trial is to determine whether a home-based digital cognitive-training program called RICORDO can enhance patients' ability to manage their own health and daily life when they have Mild Cognitive Impairment (MCI) or Subjective Cognitive Decline (SCD) and are 50 years of age or older.\n\nThe main questions it aims to answer are:\n\nDoes using RICORDO for five weeks raise the Patient Activation Measure (PAM) score more than an at-home paper-and-video education program called S.A.M.B.A.?\n\nDoes RICORDO also improve cognition, everyday functioning, quality of life and mood compared with S.A.M.B.A.?\n\nResearchers will compare individuals who train with RICORDO to those who follow S.A.M.B.A. to determine which approach is more effective.\n\nParticipants will be randomly assigned to one of the two groups and complete three 45-minute sessions per week at home for five weeks. They will also visit the clinic at the beginning and end of the program to complete questionnaires and take brief thinking tests.",[57,58],"Mild Cognitive Impairment (MCI)","Subjective Cognitive Decline (SCD)",[60,61,62,63,64],"Mild Cognitive Impairment","Digital Therapeutics","Cognitive Rehabilitation","Patient Activation","Home-Based Intervention",{"date":66,"type":36},"2026-04-29",{"date":68,"type":36},"2025-11-28",{"date":39,"type":20},{"name":41,"class":42},""]