Clinical trial NCT05697354: New Virtual Reality Technologies and Telemedicine for Cognitive Rehabilitation in Alzheimer's Disease
Official title: Harmonization and Application of Cognitive Rehabilitation Protocols Using New Technologies of Virtual Reality and Telemedicine, in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: Multicentric study involving the following 14 italian hospitals: San Raffaele Hospital of Milan, Fondazione Istituto Neurologico Carlo Besta, Istituto delle Scienze Neurologiche di Bologna, Fondazione Ca' Granda - Ospedale Maggiore Policlinico, Fondazione Don Carlo Gnocchi Onlus, Istituto Auxologico Italiano, Humanitas Mirasole, Istituti Clinici Scientifici Maugeri, Fondazione Istituto Neurologico Nazionale C. Mondino, Istituto Centro San Giovanni di Dio Fatebenefratelli, Fondazione Ospedale San Camillo, Fondazione Santa Lucia, Fondazione Policlinico Universitario Agostino Gemelli, Associazione Oasi Maria SS Onlus.

40 patients affected by Alzheimer's disease, with initial to severe cognitive impairment (MMSE 13-24), and 1 of their caregivers (total caregivers: N=40) will be included in the study (total n= 80 subjects).

The protocol provides for two treatment groups:

* Tablet group (total number = 20 patients): cognitive rehabilitation carried out in telemedicine at home with tablets (using Khymeia VRRS Home Tablet equipment).
* App group (total number = 20 patients): cognitive rehabilitation carried out in telemedicine at home with the App (Khymeia App Medico Amico).

Each AD patient, regardless of the severity of the cognitive impairment in progress, will be assigned to a treatment group. Allocation to the treatment group will be randomized by stratified randomization by severity of cognitive impairment (initial and moderate level, having MMSE between 24 and 18, vs., medium-severe level, having MMSE between 17 and 13).

Cognitive rehabilitation, for each group, will last two months. Patients will undergo 45 minutes of telehealth cognitive rehabilitation per day, 5 days a week, for a total duration of 2 months.

In both groups (Tablet or App), the rehabilitation exercises will be focused on the following cognitive functions:

* Language
* Attention
* Executive functions
* Verbal memory
* Visuo-spatial memory

Evaluations will be carried out PRE and POST treatment, remotely (patient and caregiver at home, neuropsychologist in hospital).

PRE Ratings:

* Within 7 days before the start of treatment;
* Patient assessments: Mini Mental State Examination (primary outcome), quality of life in Alzheimer's disease (QoL-AD), Geriatric Depression Scale (GDS);
* Caregiver assessments: Beck Depression Inventory-II (BDI).

POST Ratings:

* Within 7 days after the last treatment session;
* Patient assessments: Mini Mental State Examination (primary outcome), quality of life in Alzheimer's disease (QoL-AD), Geriatric Depression Scale (GDS);
* Caregiver assessments: Beck Depression Inventory-II (BDI), System Usability Scale (SUS).

Total study duration per participant: 2.5 months.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Change from Mini Mental State Examination after treatment
timeFrame: After 2 months of treatment
Secondary outcomes:
measure: Change in Quality of life in Alzheimer's disease after treatment
timeFrame: After 2 months of treatment
measure: Change in Geriatric Depression Scale after treatment
timeFrame: After 2 months of treatment
measure: Change in Beck Depression Inventory-II after treatment
timeFrame: After 2 months of treatment
measure: System Usability Scale after treatment
timeFrame: After 2 months of treatment
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Raffaele
Study officials:
affiliation: Ospedale San Raffaele
name: Federica Alemanno, Psy.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: