AgingPhase 2NCT03408509
Cognitive Training to Promote Brain Health: Implementation and Engagement
A Phase 2 study testing Computerized cognitive training in people with Aging and Mild Cognitive Impairment, run by Universidade Federal do Rio de Janeiro at 1 site in Ireland.
Trial summary
Cognition encompasses memory, attention, language and other brain capacities that are necessary for good quality of life and independence. Age-related cognitive decline starts at the third decade of life and in some cases can start to impact daily functioning in the late forties. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Aging, Mild Cognitive Impairment
- What is being tested?
- Computerized cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 12 Jan 2018to 31 Dec 2019
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being evaluated at a memory clinic in the last year, or be the care partner of a person evaluated at a memory clinic
- Adequate visual and auditory acuity to allow practice on the computerized training exercises
- Physical ability sufficient to allow performance of the computerized training exercises
- Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
Who cannot join
- Any medical condition that precludes performing the computerized training exercises
- Advanced dementia.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
St James Hospital
Dublin, D8
Brian Lawlor, M.D., BLAWLOR@STJAMES.IE
About this study
Cognition encompasses memory, attention, language and other brain capacities that are necessary for good quality of life and independence. Age-related cognitive decline starts at the third decade of life and in some cases can start to impact daily functioning in the late forties. Dementia is the most devastating consequence associated with age-related cognitive decline. Recent studies indicate that improving cognition by means of intensive computerized brain training can mitigate some aspects of agerelated cognitive decline, and may even have a role in preventing or delaying dementia onset. Critically, the capacity of a given individual to improve their cognitive performance after training is fundamentally related to engagement with the exercises. Currently, little is known about how to apply intensive computerized cognitive training effectively in the health system, ensuring engagement and best progress. This project aims to tackle this challenge by developing, applying and testing personalized approaches to implement cognitive training in daily life of older adults that were recently evaluated at Memory Clinics and their care partners. The community readiness approach will be implemented using semi-structured interviews, conducted with subjects that may be interested in cognitive training, key informant, and key stakeholders. Using this information, the investigators will design an individualized training program and follow up its application in a feasibility trial. Twenty participants, recently evaluated at different Memory Clinics in Ireland, will be recruited, interviewed and invited to engage, over the ensuing 2 to 3 months, in computerized cognitive training. Subjects will be assessed after completion of the intervention for training adherence and individual gains on the computerized exercises. In order to gain insight about regional specificities of the approach the investigators will perform a parallel project using the same methodology in Brazil. This project is expected to inform the future implementation of cognitive training in public health policies for older adults.
- Conditions
- Aging, Mild Cognitive Impairment
- Being tested
- Computerized cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive trainingBehavioural
Posit Science Inc. will supply the software for the computerized cognitive training through the platform BrainHQ, which is available on line. The training program consists of a set of computerized exercises designed to improve the speed and accuracy of sensory information processing while engaging neuromodulatory systems involved in attention and reward. The rationale is that, in order to understand and remember information, the brain must first generate precise and reliable neurological responses that represent the sensory stimuli. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations. The goal is to increase the effectiveness with which these stimuli engage and drive plastic changes in brain systems. Engagement is monitored by electronic data upload following each training session.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training | Experimental | Not described Receives: Behavioral: Computerized cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement
will be defined as a continuous variable (number of hours of training completed by the participant).
Measured: 3 months
Secondary outcomes (4)
Individual gains on the computerized exercises
The computerized cognitive training platform, called BrainHQ, provided by Posit Science Inc, provides one measure of the individual gains on the computerized exercises with training.
Measured: 3 months
Quantitative measure of motivation with the computerized training exercise
Motivation will be assessed by the quantitative score provided by the Adapted Ultrech Engagement Scale - UWES. The Utrecht Engagement Scale has 17 items that are scored on a 7-point Likert scale indicating the frequency with which engagement at a given activity happens in the situations described in each item (0 indicates "never" and 6 "always"). The factors Vigor and Concentration have six items each and the factor Dedication has 5 items. The final score of the Engagement corresponds to the sum of the scores on the three factors.
Measured: 3 months
Qualitative motivation with the computerized training exercise
Qualitative motivation will be assessed using semi-structured interview.
Measured: 3 months
Training adherence (dichotomic variable)
Training adherence will be defined as training more than 10 hours
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start12 Jan 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dublin, Trinity College, Global Brain Health Institute (GBHI)
- Responsible party
- Principal investigator, Rogerio Panizzutti, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408509
- Sponsor's protocol ID
- GBHI_ALZ-18-544160
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training to Promote Brain Health: Implementation and Engagement
- ClinicalTrials.gov ID
- NCT03408509
- Acronym / sponsor ID
- GBHI_ALZ-18-544160
- Conditions
- Aging, Mild Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- University of Dublin, Trinity College, Global Brain Health Institute (GBHI)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 24 Jan 2018 (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.
Cognition encompasses memory, attention, language and other brain capacities that are necessary for good quality of life and independence. Age-related cognitive decline starts at the third decade of life and in some cases can start to impact daily functioning in the late forties. Dementia is the most devastating consequence associated with age-related cognitive decline. Recent studies indicate that improving cognition by means of intensive computerized brain training can mitigate some aspects of agerelated cognitive decline, and may even have a role in preventing or delaying dementia onset. Critically, the capacity of a given individual to improve their cognitive performance after training is fundamentally related to engagement with the exercises. Currently, little is known about how to apply intensive computerized cognitive training effectively in the health system, ensuring engagement and best progress. This project aims to tackle this challenge by developing, applying and testing personalized approaches to implement cognitive training in daily life of older adults that were recently evaluated at Memory Clinics and their care partners. The community readiness approach will be implemented using semi-structured interviews, conducted with subjects that may be interested in cognitive training, key informant, and key stakeholders. Using this information, the investigators will design an individualized training program and follow up its application in a feasibility trial. Twenty participants, recently evaluated at different Memory Clinics in Ireland, will be recruited, interviewed and invited to engage, over the ensuing 2 to 3 months, in computerized cognitive training. Subjects will be assessed after completion of the intervention for training adherence and individual gains on the computerized exercises. In order to gain insight about regional specificities of the approach the investigators will perform a parallel project using the same methodology in Brazil. This project is expected to inform the future implementation of cognitive training in public health policies for older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive training | Experimental | Behavioral: Computerized cognitive training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Being evaluated at a memory clinic in the last year, or be the care partner of a person evaluated at a memory clinic
- Adequate visual and auditory acuity to allow practice on the computerized training exercises
- Physical ability sufficient to allow performance of the computerized training exercises
- Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
Key exclusion criteria (2 listed)
- Any medical condition that precludes performing the computerized training exercises
- Advanced dementia.
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 trainingPosit Science Inc. will supply the software for the computerized cognitive training through the platform BrainHQ, which is available on line. The training program consists of a set of computerized exercises designed to improve the speed and accuracy of sensory information processing while engaging neuromodulatory systems involved in attention and reward. The rationale is that, in order to understand and remember information, the brain must first generate precise and reliable neurological responses that represent the sensory stimuli. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations. The goal is to increase the effectiveness with which these stimuli engage and drive plastic changes in brain systems. Engagement is monitored by electronic data upload following each training session. | Behavioural | Cognitive training |
Primary outcome
Engagement
Time frame: 3 months
will be defined as a continuous variable (number of hours of training completed by the participant).
4 secondary outcomes
Individual gains on the computerized exercises
Time frame: 3 months
Quantitative measure of motivation with the computerized training exercise
Time frame: 3 months
Qualitative motivation with the computerized training exercise
Time frame: 3 months
Training adherence (dichotomic variable)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computerized cognitive training in people with Aging and Mild Cognitive Impairment, run by Universidade Federal do Rio de Janeiro at 1 site in Ireland.
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 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: status not confirmed, as of the sponsor's last update on 26 Jan 2018. 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 Ireland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rogerio A Panizzutti, M.D., Ph.D. (+552139386390, rogerio@icb.ufrj.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement (time frame: 3 months). 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 26 Jan 2018.