Alzheimer DiseaseNCT04919005
Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
A study testing Virtual Environment in people with Alzheimer Disease, run by University of Mogi das Cruzes at 1 site in Brazil.
Trial summary
This research was carried out with the objective of verifying the possibility of intervention through cognitive training protocols to assist in the stimulation of neurons and to delay the degradation resulting from Alzheimer's disease in its initial phase. Read more about this study
- Who is it for?
- Ages 19 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Virtual Environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2016to 20 Jul 2017
- 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 19 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People with physical or psychological conditions allow interacting with digital games;
- Elderly over 60 years with mild Alzheimer;
- Seniors over 60 Healthy;
- Healthy Youth;
Who cannot join
- People without physical or psychological conditions allow interacting with digital games;
- Elderly people over 60 years old who have any type of dementia other than Alzheimer, or moderate or severe Alzheimer;
Trial locations and contacts
1 site in 1 country.
About this study
This research was carried out with the objective of verifying the possibility of intervention through cognitive training protocols to assist in the stimulation of neurons and to delay the degradation resulting from Alzheimer's disease in its initial phase. The specific objective of this research was to develop and validate a virtual environment of games (called SorrisoTur) that allows the intervention of cognitive training.
Read the detailed description
SorrisoTur encompasses cognitive training concepts and protocols in playful situations, which were coded in the form of 2D mini-games that are run on a computer connected to the Web, and designed to stimulate cognitive domains, such as memory, executive functions, spatial-visual skills, language (expression, comprehension, reading, and writing) and personality/behavior. For the comparison of results, three groups were created; one group of elderly people with Alzheimer's disease at an early stage, one group formed by healthy elderly, and another group with young people and applied Mini-Mental State Examination (MMSE) and Wechsler Intelligence Scale for Adults (WAIS-III) before and after of interventions with the games.
- Conditions
- Alzheimer Disease
- Being tested
- Virtual Environment
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual EnvironmentOther
The Virtual Environment was called SorrisoTur and consists of 10 mini-games with difficulty levels in a limited number of cities and mini-games distributed in a thematic scenario of the map of Brazil. The virtual environment consists of the cognitive training mini-games within a theme for all screens, mini-games, and information. The interventions with the Virtual Environment were administered in periods of one hour, twice a week, for a month.
| Study group | Role | What they receive |
|---|---|---|
| Healthy elderly people | Experimental | Twelve healthy elderly people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test. Receives: Other: Virtual Environment |
| Elderly people with Alzheimer's in the initial phase | Experimental | Seven elderly people with Alzheimer's in the initial phase. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test. Receives: Other: Virtual Environment |
| Healthy young people | Experimental | Fifteen healthy young people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test. Receives: Other: Virtual Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Wechsler Intelligence Scale for Adults (WAIS-III)
The WAIS-III is an intellectual assessment that aims to analise the measures of the following Factorial Scales and Indexes: Verbal IQ (intelligence quotient), Execution IQ, Total IQ, Verbal Understanding Index, Perceptual Organization Indexes, Operational Memory Indexes and Processing speed index.
Measured: Baseline and after 4 weeks
Change on Mini Mental State Examination (MMSE)
The MMSE is a data collection instrument widely used in cases of dementia, it evaluates temporal and spatial orientation, short-term memory (immediate or attention) and skills of evocation, calculation, praxis, visuospatial, communication and language.
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Jul 2016
- Primary completion30 Apr 2017
- Study completion20 Jul 2017
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terigi Augusto Scardovelli, University of Mogi das Cruzes
- Investigators
- Marcia A Bissaco, PhD, Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919005
- Sponsor's protocol ID
- CAAE: 54290416.9.0000.5497
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
- ClinicalTrials.gov ID
- NCT04919005
- Acronym / sponsor ID
- CAAE: 54290416.9.0000.5497
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 9 Jun 2021 (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.
This research was carried out with the objective of verifying the possibility of intervention through cognitive training protocols to assist in the stimulation of neurons and to delay the degradation resulting from Alzheimer's disease in its initial phase. The specific objective of this research was to develop and validate a virtual environment of games (called SorrisoTur) that allows the intervention of cognitive training.
Detailed description
SorrisoTur encompasses cognitive training concepts and protocols in playful situations, which were coded in the form of 2D mini-games that are run on a computer connected to the Web, and designed to stimulate cognitive domains, such as memory, executive functions, spatial-visual skills, language (expression, comprehension, reading, and writing) and personality/behavior. For the comparison of results, three groups were created; one group of elderly people with Alzheimer's disease at an early stage, one group formed by healthy elderly, and another group with young people and applied Mini-Mental State Examination (MMSE) and Wechsler Intelligence Scale for Adults (WAIS-III) before and after of interventions with the games.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy elderly people | Experimental | Other: Virtual EnvironmentTwelve healthy elderly people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test. |
| Elderly people with Alzheimer's in the initial phase | Experimental | Other: Virtual EnvironmentSeven elderly people with Alzheimer's in the initial phase. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test. |
| Healthy young people | Experimental | Other: Virtual EnvironmentFifteen healthy young people. Each participant underwent a pre-test, the intervention with a Virtual Environment, and a post-test. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People with physical or psychological conditions allow interacting with digital games;
- Elderly over 60 years with mild Alzheimer;
- Seniors over 60 Healthy;
- Healthy Youth;
Key exclusion criteria (2 listed)
- People without physical or psychological conditions allow interacting with digital games;
- Elderly people over 60 years old who have any type of dementia other than Alzheimer, or moderate or severe Alzheimer;
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 |
|---|---|---|
| Virtual EnvironmentThe Virtual Environment was called SorrisoTur and consists of 10 mini-games with difficulty levels in a limited number of cities and mini-games distributed in a thematic scenario of the map of Brazil. The virtual environment consists of the cognitive training mini-games within a theme for all screens, mini-games, and information. The interventions with the Virtual Environment were administered in periods of one hour, twice a week, for a month. | Other | Elderly people with Alzheimer's in the initial phase, Healthy elderly people, Healthy young people |
Primary outcome
Change on Wechsler Intelligence Scale for Adults (WAIS-III)
Time frame: Baseline and after 4 weeks
The WAIS-III is an intellectual assessment that aims to analise the measures of the following Factorial Scales and Indexes: Verbal IQ (intelligence quotient), Execution IQ, Total IQ, Verbal Understanding Index, Perceptual Organization Indexes, Operational Memory Indexes and Processing speed index.
Change on Mini Mental State Examination (MMSE)
Time frame: Baseline and after 4 weeks
The MMSE is a data collection instrument widely used in cases of dementia, it evaluates temporal and spatial orientation, short-term memory (immediate or attention) and skills of evocation, calculation, praxis, visuospatial, communication and language.
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 9 Jun 2021.
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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.
Marcia A Bissaco, PhD principal investigator
University of Mogi das Cruzes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Environment in people with Alzheimer Disease, run by University of Mogi das Cruzes at 1 site in Brazil.
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 4 inclusion and 2 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 9 Jun 2021. 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 Brazil. 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 on Wechsler Intelligence Scale for Adults (WAIS-III) (time frame: Baseline and after 4 weeks). 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?
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 9 Jun 2021.