Alzheimer DiseaseTaskCog-IVNNCT05697354
New Virtual Reality Technologies and Telemedicine for Cognitive Rehabilitation in Alzheimer's Disease
A study testing Cognitive rehabilitation using interactive tablet and Cognitive rehabilitation using smartphone App Medico Amico in people with Alzheimer Disease, run by Ospedale San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Cognitive rehabilitation using interactive tablet and Cognitive rehabilitation using smartphone App Medico Amico
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 30 Aug 2021to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Denial of informed consent;
- Psychiatric diseases;
- Relevant cerebrovascular damage;
- Disabling visual or hearing impairments;
- Psychosis;
- Major depression;
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- Abuse of alcohol or drugs;
- Use of psychopharmacological agents that may interfere with test performance or treatment.
- Participation in study protocols with experimental drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harmonization and Application of Cognitive Rehabilitation Protocols Using New Technologies of Virtual Reality and Telemedicine, in Alzheimer's Disease
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.
Read more
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).
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Cognitive rehabilitation using interactive tablet, Cognitive rehabilitation using smartphone App Medico Amico
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitation using interactive tabletProcedure or surgery
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.
Cognitive rehabilitation using smartphone App Medico AmicoProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Tablet group | Experimental | The Tablet group will carry out the exercises using the Khymeia VRRS Home Tablet. Receives: Procedure: Cognitive rehabilitation using interactive tablet |
| App group | Experimental | The App group will perform the exercises on their smartphone using the Khymeia Medico Amico App. Receives: Procedure: Cognitive rehabilitation using smartphone App Medico Amico |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 2 months of treatment
Secondary outcomes (4)
Change in Quality of life in Alzheimer's disease after treatment
The QOL-AD is a 13-item questionnaire designed to investigate, through the patient and caregiver, the quality of life (QOL) of patients diagnosed with Alzheimer's disease (AD). It ranges from 13 to 52. An increase in the scores indicate an improvement of the quality of life.
Measured: After 2 months of treatment
Change in Geriatric Depression Scale after treatment
Most widespread assessment scale for detecting depressive symptoms in frail elderly patients and in patients with dementia. It ranges from 0 (no depression) to 15 (probable depression). An increase in the GDS score indicates a worsening of the depression symptoms.
Measured: After 2 months of treatment
Change in Beck Depression Inventory-II after treatment
The BDI is a self-report tool consisting of 21 items. It assesses common symptoms of depression, and is considered a valid and reliable tool for screening for depression in the general population. It ranges from 0 (no depression) to 63 (major depression). Higher scores indicate an increase in depression severity.
Measured: After 2 months of treatment
System Usability Scale after treatment
The SUS is a Likert scale made up of ten elements which offers a global view of the subjective assessments of the usability of a system. Usability measurements consider several aspects: effectiveness (users can successfully achieve their goals), efficiency (how much effort and resources are spent to achieve those goals), and satisfaction (the experience was satisfactory). Scores range from 10 (poor satisfaction) to 100 (high satisfaction). High scores indicate a good satisfaction of the participant.
Measured: After 2 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start30 Aug 2021
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federica Alemanno, Ospedale San Raffaele
- Investigators
- Federica Alemanno, Psy.D, Ph.D., Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697354
- Sponsor's protocol ID
- TaskCog-IVN
- Acronym
- TaskCog-IVN
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonization and Application of Cognitive Rehabilitation Protocols Using New Technologies of Virtual Reality and Telemedicine, in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05697354
- Acronym / sponsor ID
- TaskCog-IVN / TaskCog-IVN
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet group | Experimental | Procedure: Cognitive rehabilitation using interactive tabletThe Tablet group will carry out the exercises using the Khymeia VRRS Home Tablet. |
| App group | Experimental | Procedure: Cognitive rehabilitation using smartphone App Medico AmicoThe App group will perform the exercises on their smartphone using the Khymeia Medico Amico App. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Denial of informed consent;
- Psychiatric diseases;
- Relevant cerebrovascular damage;
- Disabling visual or hearing impairments;
- Psychosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive rehabilitation using interactive tabletthe 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. | Procedure or surgery | Tablet group |
| Cognitive rehabilitation using smartphone App Medico Amicothe 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. | Procedure or surgery | App group |
Primary outcome
Change from Mini Mental State Examination after treatment
Time frame: After 2 months of 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.
4 secondary outcomes
Change in Quality of life in Alzheimer's disease after treatment
Time frame: After 2 months of treatment
Change in Geriatric Depression Scale after treatment
Time frame: After 2 months of treatment
Change in Beck Depression Inventory-II after treatment
Time frame: After 2 months of treatment
System Usability Scale after treatment
Time frame: After 2 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federica Alemanno, Psy.D, Ph.D. principal investigator
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive rehabilitation using interactive tablet and Cognitive rehabilitation using smartphone App Medico Amico in people with Alzheimer Disease, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Mini Mental State Examination after treatment (time frame: After 2 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.