New Virtual Reality Technologies and Telemedicine for Cognitive Rehabilitation in Alzheimer's Disease
TaskCog-IVN
Harmonization and Application of Cognitive Rehabilitation Protocols Using New Technologies of Virtual Reality and Telemedicine, in Alzheimer's Disease
1 other identifier
interventional
40
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Aug 2021
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2021
CompletedFirst Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedJanuary 25, 2023
January 1, 2023
4 months
January 12, 2023
January 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Mini Mental State Examination after treatment
Neuropsychological test for the evaluation of cognitive efficiency and the presence of cognitive impairment. The test consists of thirty items, which refer to seven different cognitive areas: orientation in time, orientation in space, memory, attention, and calculation, language, constructive ability. It ranges from 0 (poorest score) to 30 (normal cognition). An increase of the MMSE score indicate an improvement in general cognition.
After 2 months of treatment
Secondary Outcomes (4)
Change in Quality of life in Alzheimer's disease after treatment
After 2 months of treatment
Change in Geriatric Depression Scale after treatment
After 2 months of treatment
Change in Beck Depression Inventory-II after treatment
After 2 months of treatment
System Usability Scale after treatment
After 2 months of treatment
Study Arms (2)
Tablet group
EXPERIMENTALThe Tablet group will carry out the exercises using the Khymeia VRRS Home Tablet.
App group
EXPERIMENTALThe App group will perform the exercises on their smartphone using the Khymeia Medico Amico App.
Interventions
the cognitive rehabilitation exercises will be administered using the Khymeia VRRS Home Tablet. Patients will be asked to actively carry out exercises focused on the following cognitive functions: language, attention, executive functions, verbal memory, visuo-spatial memory.
the cognitive rehabilitation exercises will be administered through patients' smartphone using the Medico Amico App. Patients will be asked to observe and concentrate on exercises focused on the following cognitive functions: language, attention, executive functions, verbal memory, visuo-spatial memory.
Eligibility Criteria
You may qualify if:
- inform consent
- Proven 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale San Raffaele
Milan, 20132, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Federica Alemanno, Psy.D, Ph.D.
Ospedale San Raffaele
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Psy.D., Ph.D., Responsible of the Neuropsychology Service, IRCCS San Raffaele Scientific Institute
Study Record Dates
First Submitted
January 12, 2023
First Posted
January 25, 2023
Study Start
August 30, 2021
Primary Completion
December 21, 2021
Study Completion
December 21, 2021
Last Updated
January 25, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share