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Completed
NCT05697354
New Virtual Reality Technologies and Telemedicine for Cognitive Rehabilitation in Alzheimer's Disease
Conditions: Alzheimer Disease
Sex: All
Ages: 50 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 40
Sponsor: Ospedale San Raffaele
Location: Italy
Summary
Main objective: To verify the effectiveness of a cognitive rehabilitation program in Alzheimer patients, based on virtual reality, delivered remotely, at the patient's home, with two distinct methods: a tablet or an App (on the patient's smartphone).Total treatment duration: 2 months.Main endpoint: Post rehabilitation assessment of the patient's cognitive level; Secondary endpoints: assessment of patients' quality of life quality of life and patients' and caregivers' satisfaction.The neuropsychological assessment of the patients includes: Mini Mental State Examination (primary outcome), quality of life in Alzheimer's disease (QoL-AD), Geriatric Depression Scale (GDS).
The following questionnaires will be submitted to caregivers: Beck Depression Inventory-II (BDI), System Usability Scale (SUS).
Eligibility Criteria
Inclusion Criteria:inform consentProven diagnosis of Alzheimer's disease;MMSE score between 13 and 24;Aged between 50 and 80 years;Stable drug therapy for at least 3 months.Exclusion Criteria:Denial of informed consent;Psychiatric diseases;Relevant cerebrovascular damage;Disabling visual or hearing impairments;Psychosis;Major depression;Abuse of alcohol or drugs;Use of psychopharmacological agents that may interfere with test performance or treatment.Participation in study protocols with experimental drugs.
Source: ClinicalTrials.gov (NCT05697354). StuddyBuddy aggregates publicly available trial information.
