Alzheimer DiseaseJDomeNCT05402423
An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease (JDome)
A study testing Computerized cognitive training plus aerobic exercise with the JDome System and Computerized cognitive training plus aerobic exercise with standard exercise bike in people with Alzheimer Disease, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial summary
JDOME is a randomized controlled trial to test the effectiveness of a computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system vs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Computerized cognitive training plus aerobic exercise with the JDome System and Computerized cognitive training plus aerobic exercise with standard exercise bike
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jun 2022to 26 Jun 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 and over;
- Pre-existing diagnosis of Alzheimer's, in mild phase, according to the 2011 criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA);
- Clinical Dementia Rating Scale CDR = 1;
- Mini Mental State Examination MMSE > 19;
- Functional Ambulation Categories FAC ≥4;
- Tinetti scale ≥ 20;
- Presence of a contact family caregiver
- Reside at home
Who cannot join
- Failure to meet the inclusion criteria
- Sensory deficits not compensated by the use of prostheses
- Psychological and behavioral disorders not compensated by drug treatment
- Medical contraindication to moderate intensity aerobic exercise
Trial locations and contacts
1 site in 1 country.
Italy1 site
Cognitive Disorders and Dementia (CDCD) -INRCA Hospital
Ancona, 60127
About this study
Official title: An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease: the JDome Study Protocol
JDOME is a randomized controlled trial to test the effectiveness of a computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system vs. a computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike in subjects with Alzheimer's Disease at early stage. The JDome BikeAround is a tool that take people with dementia on a virtual bicycle tour along the paths of memories. It combines an exercise bike, a dome-shaped projector and Google Street View technology.
Read the detailed description
JDOME study is designed as a randomized controlled trial to test the effectiveness of a training that combines the JDome virtual reality system for aerobic exercise with computerized cognitive training via tablet. The Experimental Group (EG) will receive computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system (a tool that combines an exercise bike, a dome-shaped projector and Google Street View technology).The Control Group (CG) will receive computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike.
Assessment will be performed at the baseline (T0), at the end of intervention (after eight weeks -T1) and 12 weeks after the end of intervention (follow-up T2).
The primary aim is to assess the stabilization of the global cognition of people with mild-stage Alzheimer's disease at the Mini-Mental State Examination (MMSE) and at the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog); The secondary aim is the analyses of the modification of the quality of life, mood, behavioral disturbances, and physical function in people with mild-stage Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- Computerized cognitive training plus aerobic exercise with the JDome System, Computerized cognitive training plus aerobic exercise with standard exercise bike
- Keywords
- Alzheimer Disease, virtual system, aerobic exercise, cognitive training, dementia, quality of life
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive training plus aerobic exercise with the JDome SystemDevice
Sixteen treatment sessions of 60 minutes will be conducted (2 training sessions per week, for 8 weeks).
Each session will involve the following activities:
- 30 minutes of computerized cognitive training with the Brainer web platform, a medical device that contains 78 exercises in the five cognitive areas involved in the degeneration process of dementia
- 30 minutes of aerobic training with the JDOME system,
Computerized cognitive training plus aerobic exercise with standard exercise bikeDevice
Sixteen treatment sessions of 60 minutes will be conducted (2 training sessions per week, for 8 weeks).
Each session will involve the following activities:
- 30 minutes of computerized cognitive training with the Brainer web platform, a medical device that contains 78 exercises in the five cognitive areas involved in the degeneration process of dementia
- 30 minutes of aerobic training with standard exercise bike
| Study group | Role | What they receive |
|---|---|---|
| JDome rehabilitation group | Experimental | Patients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with the JDome System Receives: Device: Computerized cognitive training plus aerobic exercise with the JDome System |
| control group | Active comparator | Patients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with standard exercise bike Receives: Device: Computerized cognitive training plus aerobic exercise with standard exercise bike |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cognitive impairment
Mini-Mental State Examination was designed as a clinical method for grading cognitive impairment. The score ranges from 0 to 30: scores ≥ 24 indicate normality, between 18-23 indicate mild cognitive impairment, between 11-17 moderate cognitive deficits, scores ≤ 10 severe cognitive impairments. The reported score will be corrected according to age and education.
Measured: baseline, 8, and 22 weeks later
change in short and medium term memory
Alzheimer's Disease Assessment Scale (ADAS-cog) consists of 11 items that investigate: short and medium term memory, language, praxia (simple, constructive, ideational), temporal-spatial orientation. The score ranges from 0 (no cognitive impairment) to 70 (maximum cognitive impairment).
Measured: baseline, 8 and 22 weeks later
Secondary outcomes (4)
change in quality of life
Alzheimer's Disease scale (QoL-AD) includes 13 items that evaluate subjective (eg, perceived quality of life and psychological well-being) and objective (eg, behavioral competence and environment) components of the quality of life. Items are rated by subjects with dementia on a 4-point scale from 1 (poor) to 4 (excellent). Higher scores indicate a better quality of life.
Measured: baseline and 8, 22 weeks later
change in physical performance
Short Physical Performance Battery (SPPB) is a short battery of tests designed to assess the function of the lower limbs. This scale consists of 3 different sections: balance assessment, evaluation of walking on 4 linear meters, evaluation of the ability to perform, for 5 consecutive times, the sit to stand from a chair, without using the upper limbs. The total scale score therefore has a range from 0 to 12. A total score below 10 indicates frailty and a high risk of disability and falls. The 1-point change in score from pre to post test is of clinical relevance.
Measured: baseline, 8 and 22 weeks later
change in signs and symptoms of major depression
Cornell Scale for Depression in dementia (CSDD) contains 19 items evaluating signs and symptoms of major depression in individuals with dementia. Each item is rated for severity on a scale from 0 (absent) to 2 (severe). The information is collected through clinical observation and through two semi-structured interviews: one addressed to the caregiver and one to the person with dementia. The total score, given by the sum of the 19 items, if lower than 6 indicates the absence of depressive symptoms, if higher than 10 it indicates a probable major depression and finally if higher than 18 it indicates the presence of major depression
Measured: baseline, 8 and 22 weeks later
change in neuropsychiatric disturbances
Neuropsychiatric Inventory (NPI) evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. A total NPI score and a total caregiver distress score are calculated. The total NPI score, which can range from 1 to 144, is the product of the frequency of manifestation and the severity of each disorder. Higher scores indicate more frequent and more severe behavioral problems
Measured: baseline, 8 and 22 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start27 Jun 2022 (estimated)
- Primary completion26 Jun 2023 (estimated)
- Study completion26 Jun 2023 (estimated)
Why it stopped: It was not possible to acquire the medical device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Cariverona, Italy
- Responsible party
- Sponsor
- Investigators
- Giuseppe Pelliccioni, MD, Principal investigator, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402423
- Sponsor's protocol ID
- INRCA_003_2022
- Acronym
- JDome
- Status last verified
- Oct 2023
- First submitted
- 30 May 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gambella E, Margaritini A, Benadduci M, Rossi L, D'Ascoli P, Riccardi GR, Pasquini S, Civerchia P, Pelliccioni G, Bevilacqua R, Maranesi E. An integrated intervention of computerized cognitive training and physical exercise in virtual reality for people with Alzheimer's disease: The jDome study protocol. Front Neurol. 2022 Aug 12;13:964454. doi: 10.3389/fneur.2022.964454. eCollection 2022.
PubMed 36034306
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease: the JDome Study Protocol
- ClinicalTrials.gov ID
- NCT05402423
- Acronym / sponsor ID
- JDome / INRCA_003_2022
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, virtual system, aerobic exercise, cognitive training, dementia, quality of life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was not possible to acquire the medical device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Fondazione Cariverona, Italy
- Study start
- 27 Jun 2022 (estimated)
- Primary completion
- 26 Jun 2023 (estimated)
- Study completion
- 26 Jun 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
JDOME is a randomized controlled trial to test the effectiveness of a computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system vs. a computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike in subjects with Alzheimer's Disease at early stage. The JDome BikeAround is a tool that take people with dementia on a virtual bicycle tour along the paths of memories. It combines an exercise bike, a dome-shaped projector and Google Street View technology.
Detailed description
JDOME study is designed as a randomized controlled trial to test the effectiveness of a training that combines the JDome virtual reality system for aerobic exercise with computerized cognitive training via tablet. The Experimental Group (EG) will receive computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system (a tool that combines an exercise bike, a dome-shaped projector and Google Street View technology).The Control Group (CG) will receive computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike.
Assessment will be performed at the baseline (T0), at the end of intervention (after eight weeks -T1) and 12 weeks after the end of intervention (follow-up T2).
The primary aim is to assess the stabilization of the global cognition of people with mild-stage Alzheimer's disease at the Mini-Mental State Examination (MMSE) and at the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog); The secondary aim is the analyses of the modification of the quality of life, mood, behavioral disturbances, and physical function in people with mild-stage Alzheimer's disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JDome rehabilitation group | Experimental | Device: Computerized cognitive training plus aerobic exercise with the JDome SystemPatients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with the JDome System |
| control group | Active comparator | Device: Computerized cognitive training plus aerobic exercise with standard exercise bikePatients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with standard exercise bike |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Aged 65 and over;
- Pre-existing diagnosis of Alzheimer's, in mild phase, according to the 2011 criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA);
- Clinical Dementia Rating Scale CDR = 1;
- Mini Mental State Examination MMSE > 19;
- Functional Ambulation Categories FAC ≥4;
Key exclusion criteria (4 listed)
- Failure to meet the inclusion criteria
- Sensory deficits not compensated by the use of prostheses
- Psychological and behavioral disorders not compensated by drug treatment
- Medical contraindication to moderate intensity aerobic exercise
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 |
|---|---|---|
| Computerized cognitive training plus aerobic exercise with the JDome SystemSixteen treatment sessions of 60 minutes will be conducted (2 training sessions per week, for 8 weeks). Each session will involve the following activities: * 30 minutes of computerized cognitive training with the Brainer web platform, a medical device that contains 78 exercises in the five cognitive areas involved in the degeneration process of dementia * 30 minutes of aerobic training with the JDOME system, | Device | JDome rehabilitation group |
| Computerized cognitive training plus aerobic exercise with standard exercise bikeSixteen treatment sessions of 60 minutes will be conducted (2 training sessions per week, for 8 weeks). Each session will involve the following activities: * 30 minutes of computerized cognitive training with the Brainer web platform, a medical device that contains 78 exercises in the five cognitive areas involved in the degeneration process of dementia * 30 minutes of aerobic training with standard exercise bike | Device | control group |
Primary outcome
change in cognitive impairment
Time frame: baseline, 8, and 22 weeks later
Mini-Mental State Examination was designed as a clinical method for grading cognitive impairment. The score ranges from 0 to 30: scores ≥ 24 indicate normality, between 18-23 indicate mild cognitive impairment, between 11-17 moderate cognitive deficits, scores ≤ 10 severe cognitive impairments. The reported score will be corrected according to age and education.
change in short and medium term memory
Time frame: baseline, 8 and 22 weeks later
Alzheimer's Disease Assessment Scale (ADAS-cog) consists of 11 items that investigate: short and medium term memory, language, praxia (simple, constructive, ideational), temporal-spatial orientation. The score ranges from 0 (no cognitive impairment) to 70 (maximum cognitive impairment).
4 secondary outcomes
change in quality of life
Time frame: baseline and 8, 22 weeks later
change in physical performance
Time frame: baseline, 8 and 22 weeks later
change in signs and symptoms of major depression
Time frame: baseline, 8 and 22 weeks later
change in neuropsychiatric disturbances
Time frame: baseline, 8 and 22 weeks later
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Derived from this study: PubMed 36034306Gambella E, Margaritini A, Benadduci M, Rossi L, D'Ascoli P, Riccardi GR, Pasquini S, Civerchia P, Pelliccioni G, Bevilacqua R, Maranesi E. An integrated intervention of computerized cognitive training and physical exercise in virtual reality for people with Alzheimer's disease: The jDome study protocol. Front Neurol. 2022 Aug 12;13:964454. doi: 10.3389/fneur.2022.964454. eCollection 2022.
- 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.
Giuseppe Pelliccioni, MD principal investigator
IRCCS INRCA, Ancona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive training plus aerobic exercise with the JDome System and Computerized cognitive training plus aerobic exercise with standard exercise bike in people with Alzheimer Disease, run by Istituto Nazionale di Ricovero e Cura per Anziani 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 8 inclusion and 4 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: withdrawn, as of the sponsor's last update on 26 Oct 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 was withdrawn before enrolling participants, so there are no results.
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 in cognitive impairment (time frame: baseline, 8, and 22 weeks later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402423, which also lists 1 linked publication.
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 26 Oct 2023.