Contact information
Type
Scientific
Primary contact
Prof Clive Ballard
ORCID ID
Contact details
Wolfson Centre for Age-Related Diseases
King's College London
Guy's Campus
London
SE1 1UL
United Kingdom
-
clive.ballard@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol version 9 21/05/09
Study information
Scientific title
A randomised single-blind three-armed controlled trial comparing evidence-based reasoning brain training (RBT), general brain training (GBT) and a control treatment to determine short term and sustained improvements in cognitive function
Acronym
BrainTrain
Study hypothesis
Study 1: All adults
Primary hypothesis:
1. In adults of all ages, there will be significant improvements in global cognition measured by a composite cognitive score in people allocated to RBT compared to those allocated to control after 6 weeks and 12 months of brain training.
Secondary hypotheses:
1. There will significant improvements in fluid intelligence and other aspects of cognition including attention, memory and working memory in people allocated to RBT compared to those allocated to the control treatment after 6 weeks or 12 months of training
2. There will no significant improvements in cognitive outcomes in people allocated to GBT compared to those allocated to the control treatment after 6 weeks or 12 months of training
3. There will significant improvements in a broad range of cognitive outcomes and a composite cognitive score and specifically in fluid intelligence and reasoning in people allocated to RBT compared to those allocated to the GBT treatment after 6 weeks or 12 months of training
Study 2: Adults aged greater than 60 years
Primary hypothesis:
1. In people over the age of 60, instrumental activites of daily living (IADL) will be significantly improved in people allocated to RBT compared to those allocated to a control treatment after 12 months of brain training.
Secondary hypotheses:
1. In people with age-associated cognitive decline (AACD), there will be significant improvement in a broad range of cognitive outcomes, a composite cognitive score and IADL in people allocated to RBT compared to those allocated to the control treatment over 12 months of brain training
2. There will significant improvements in attention, memory, working memory, fluid intelligence and a composite cognitive score in people over 60 allocated to RBT compared to those allocated to the control treatment after 6 weeks or 12 months of training
3. There will no significant improvements in cognitive outcomes in people over 60 allocated to GBT compared to those allocated to the control treatment after 6 weeks or 12 months of training
4. There will significant improvements in a broad range of cognitive outcomes and a composite cognitive score in people over 60 allocated to RBT compared to those allocated to the GBT treatment after 6 weeks or 12 months of training
Ethics approval
Not provided at time of registration
Study design
Randomised single-blind three-armed controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dementia prevention
Intervention
1. RBT will focus upon tasks related to reasoning and problem solving. In the Willis et al (2006) study, which provides the best evidence base for sustained benefit, reasoning training was the only brain training that conferred generalised benefits on other aspects of cognition and everyday activities. The recommendation is for participants to complete the training for 10 minutes every day, although with flexibility to do more or less than the recommended amount. An initial feasibility pilot of the brain training package has been completed on 22 older individuals which has been very well received and enabled minor presentational issues to be addressed.
2. GBT will cover a range of cognitive tests other than reasoning/problem solving found in commercial brain training games. Again the recommendation is for participants to complete the training for 10 minutes every day.
3. Control: the control group will perform an internet search based task every day.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Overall performance on cognitive tasks (composite score) at 6 weeks and 12 months in all participants comparing RBT and dummy/placebo treatment
2. Everyday activities at 12 months in participants over 60 comparing RBT and dummy/placebo treatment
Secondary outcome measures
1. All participants:
Cognitive test battery including:
1.1. Memory
1.2. Working memory
1.3. Speed
1.4. Fluid intelligence
1.5. Executive function:
1.5.1. Paired Associate Learning task
1.5.2. Spatial Working Memory
1.5.3. Digit span
1.5.4. Grammatical reasoning
2. Participants over 60 years old:
2.1. Hopkins verbal learning test (HVLT - recognition subscale)
2.2. Self-reported assessment of Instrumental Activities of Daily Living (IADL) from the Minimum Data-set Home Care scale
Overall trial start date
01/01/2010
Overall trial end date
01/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
As part of an exciting partnership between the BBC and the Alzheimer's Society, the BBC will invite all adults in the UK and internationally to take part in a randomised controlled trial (RCT) of brain training. It is anticipated that between 75,000 and 100,000 participants will take part. The population will be analysed as two separate studies:
1. All adults, either sex
2. Adults aged greater than 60 years, either sex
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
75000 - 100000
Participant exclusion criteria
1. Aged less than 20 years
2. Dementia
3. Not living in UK
Recruitment start date
01/01/2010
Recruitment end date
01/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Centre for Age-Related Diseases
London
SE1 1UL
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Guy's Campus
London
SE1 1UL
United Kingdom
-
clive.ballard@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Broadcasting Corporation (BBC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Alzheimer's Society (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary