DementiaNCT02559700
Online Brain Training Intervention for Over 50s
A study testing Brain training programme in people with Dementia and Mild Cognitive Impairment, run by King's College London.
Trial summary
This study is an open trial investigating the long-term use of an online brain training programme for adults over 50. It will determine whether there is sustained benefit to cognition, and whether this group can be engaged in this form of intervention over a period of 12 months. Read more about this study
- Who is it for?
- Ages 50 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment
- What is being tested?
- Brain training programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,387 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to 31 Mar 2019
- 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 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 50,
- Have access to a computer and the internet
- Registered as a participant on the PROTECT website
Who cannot join
- Established diagnosis of dementia
About this study
Official title: Optimising Engagement in an Online Brain Training Intervention for Adults Over 50
This study is an open trial investigating the long-term use of an online brain training programme for adults over 50. It will determine whether there is sustained benefit to cognition, and whether this group can be engaged in this form of intervention over a period of 12 months.
Read the detailed description
This study will evaluate an optimised brain training programme to determine whether it is engaging for older adults and whether it results in improvement or maintenance of cognition over a 12 month period.
The Brain Training intervention
The programme is an updated version of the original 'Brain Test Britain' intervention, which was successfully evaluated in a large previous trial. It consists of a series of games or tests, completed on a computer. Each test is designed to target the participants' reasoning and problem-solving ability, for example by asking them to balance weights on a see-saw or select the 'odd-one-out' from a series of shapes. As the participants progress over the course of the study they will receive increasingly more challenging versions of each test, depending on their performance. The intervention has been updated from the original to improve engagement through improved visuals, more intelligent difficulty setting and a more engaging delivery platform.
The research delivery platform: PROTECT
A novel infrastructure resource has been developed at King's College London within the Maudsley Biomedical Research Unit for Dementia (BRU-D), which provides the opportunity to deliver the intervention to large numbers of older adults. The Platform for Research Online to investigate Cognition and Genetics in Ageing (PROTECT) is an online research tool. PROTECT is currently recruiting a cohort of over 10,000 adults over 50 who are cognitively healthy or have early cognitive impairment. Participants provide demographic and lifestyle information and will complete a battery of validated cognitive assessments annually. The focus of all research conducted through PROTECT is on the prevention of dementia and risk reduction. The optimised brain training intervention will be delivered through this platform. PROTECT has ethical approval from the NHS Research Ethics Service Committee for London Bridge (Ref: 13/LO/1578).
Study Design
Design: 12-month open online clinical trial Participants: 5000 adults over 50 Setting: Intervention delivered at home, online through the PROTECT website
Recruitment
Recruitment will be achieved through the PROTECT site through a national advertisement strategy. This will be accomplished through partnerships with the media and third sector. All participants registered on PROTECT will be invited to take part and provided with the information sheet. Participants will consent through the secure online procedure on the PROTECT site.
- Conditions
- Dementia, Mild Cognitive Impairment
- Being tested
- Brain training programme
- Keywords
- Healthy Ageing
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain training programmeBehavioural
An online package of brain training programmes
| Study group | Role | What they receive |
|---|---|---|
| Brain training programme | Experimental | Participants will complete a package of online brain training games focusing on reasoning and problem solving. The intervention will be accessed via a computer. There is no minimum or maximum dosage but participants will be recommended to complete the intervention five times a week. The package takes approximately 10 minutes to complete, depending on individual performance. Receives: Behavioral: Brain training programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reasoning ability as measured by the Baddeley Grammatical Reasoning
Measured: 12 months
Secondary outcomes (4)
Change in visual memory and learning as measured by the Paired Associate Learning Test
Measured: 12 months
Change in reaction time as measured by the Simple and Choice Reaction Test
Measured: 12 months
Change in spatial working memory as measured by the Spatial Working Memory Test
Measured: 12 months
Change in ability to complete day-to-day activities as measured by the Instrumental Activities of Daily Living scale (part of the Home Care Minimum Dataset)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion31 Mar 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,387 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Society, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Anne Corbett, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559700
- Sponsor's protocol ID
- 188008
- Status last verified
- Oct 2019
- First submitted
- 23 Sep 2015
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Engagement in an Online Brain Training Intervention for Adults Over 50
- ClinicalTrials.gov ID
- NCT02559700
- Acronym / sponsor ID
- 188008
- Conditions
- Dementia, Mild Cognitive Impairment
- Keywords
- Healthy Ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,387 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Alzheimer's Society, Imperial College London
- Study start
- Nov 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 24 Sep 2015 (estimated)
- 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 study is an open trial investigating the long-term use of an online brain training programme for adults over 50. It will determine whether there is sustained benefit to cognition, and whether this group can be engaged in this form of intervention over a period of 12 months.
Detailed description
This study will evaluate an optimised brain training programme to determine whether it is engaging for older adults and whether it results in improvement or maintenance of cognition over a 12 month period.
The Brain Training intervention
The programme is an updated version of the original 'Brain Test Britain' intervention, which was successfully evaluated in a large previous trial. It consists of a series of games or tests, completed on a computer. Each test is designed to target the participants' reasoning and problem-solving ability, for example by asking them to balance weights on a see-saw or select the 'odd-one-out' from a series of shapes. As the participants progress over the course of the study they will receive increasingly more challenging versions of each test, depending on their performance. The intervention has been updated from the original to improve engagement through improved visuals, more intelligent difficulty setting and a more engaging delivery platform.
The research delivery platform: PROTECT
A novel infrastructure resource has been developed at King's College London within the Maudsley Biomedical Research Unit for Dementia (BRU-D), which provides the opportunity to deliver the intervention to large numbers of older adults. The Platform for Research Online to investigate Cognition and Genetics in Ageing (PROTECT) is an online research tool. PROTECT is currently recruiting a cohort of over 10,000 adults over 50 who are cognitively healthy or have early cognitive impairment. Participants provide demographic and lifestyle information and will complete a battery of validated cognitive assessments annually. The focus of all research conducted through PROTECT is on the prevention of dementia and risk reduction. The optimised brain training intervention will be delivered through this platform. PROTECT has ethical approval from the NHS Research Ethics Service Committee for London Bridge (Ref: 13/LO/1578).
Study Design
Design: 12-month open online clinical trial Participants: 5000 adults over 50 Setting: Intervention delivered at home, online through the PROTECT website
Recruitment
Recruitment will be achieved through the PROTECT site through a national advertisement strategy. This will be accomplished through partnerships with the media and third sector. All participants registered on PROTECT will be invited to take part and provided with the information sheet. Participants will consent through the secure online procedure on the PROTECT site.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain training programme | Experimental | Behavioral: Brain training programmeParticipants will complete a package of online brain training games focusing on reasoning and problem solving. The intervention will be accessed via a computer. There is no minimum or maximum dosage but participants will be recommended to complete the intervention five times a week. The package takes approximately 10 minutes to complete, depending on individual performance. |
Who may qualify
- Ages
- 50 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 50,
- Have access to a computer and the internet
- Registered as a participant on the PROTECT website
Key exclusion criteria (1 listed)
- Established diagnosis of 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 |
|---|---|---|
| Brain training programmeAn online package of brain training programmes | Behavioural | Brain training programme |
Primary outcome
Change in reasoning ability as measured by the Baddeley Grammatical Reasoning
Time frame: 12 months
4 secondary outcomes
Change in visual memory and learning as measured by the Paired Associate Learning Test
Time frame: 12 months
Change in reaction time as measured by the Simple and Choice Reaction Test
Time frame: 12 months
Change in spatial working memory as measured by the Spatial Working Memory Test
Time frame: 12 months
Change in ability to complete day-to-day activities as measured by the Instrumental Activities of Daily Living scale (part of the Home Care Minimum Dataset)
Time frame: 12 months
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 7 Nov 2019.
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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.
Anne Corbett, PhD principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
A study testing Brain training programme in people with Dementia and Mild Cognitive Impairment, run by King's College London.
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 3 inclusion and 1 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 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 in reasoning ability as measured by the Baddeley Grammatical Reasoning (time frame: 12 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 7 Nov 2019.