Condition category
Nervous System Diseases
Date applied
21/05/2009
Date assigned
18/09/2009
Last edited
30/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.kcl.ac.uk

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

Publication citations

Additional files

Editorial Notes