Condition category
Nervous System Diseases
Date applied
12/11/2010
Date assigned
20/10/2011
Last edited
06/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Various lifestyle factors are thought to reduce the risk of developing age-related conditions such as Alzheimer's disease (AD) or other dementias. Recent studies with people with dementia suggest that bilingual people develop symptoms several years later than those who are monolingual. However, previous studies have left open the possibility that this effect may be due to other differences between the two groups. In this study we want to find out whether which language(s) people speak makes a difference to the kinds of difficulties they experience as they get older and the time at which these difficulties start to arise. We will be comparing people who speak only English with people who speak both Welsh and English. We will explore the reasons for any differences that we find between these two groups. In particular, we want to find out whether thinking abilities are organized differently in the brain. This information should help us to develop new preventive treatments in the future.

Who can participate?
We are currently looking to recruit 30 bilingual (Welsh and English language) people with Alzheimer's disease.

What does the study involve?
If you decide to take part, we will ask you about your use of either English or Welsh, or both, and the difficulties that led up to you being referred to the hospital clinic and when this happened. We will complete some questionnaires with you to find out more about your lifestyle and well-being, and we will ask you to complete some simple mental tasks so that we can get an idea of your thinking style.
Taking part usually involves about four visits, either at your home or at Bangor University and these can be arranged to suit. You can choose whether the researcher talks to you in English or in Welsh. If you are a Welsh speaker, some of the questions and tasks will be in Welsh and others in English.
We would also like if possible to speak to a relative (e.g. husband, wife, son or daughter) or to someone who knows you well (e.g. a close friend), but we will only do this if you agree. We will ask you to nominate the best person for us to talk to. The researcher will meet with this person on one occasion or will speak to him/her on the telephone. We may need to request some information from your medical records, for example the date when you were first referred to the clinic or the results of any relevant assessments. We will only do this if you agree. The information would be provided by NHS staff, so the researcher would not access your records directly.

What are the possible benefits and risks of taking part?
You may find it interesting and enjoyable to talk with the researcher and complete the questionnaires and tasks included in the study. The information we get from this study will help us understand more about ways of preventing or delaying the start of some of the difficulties that older people can experience. This means that by taking part you will be helping others in the future. We do not think that taking part will involve any disadvantages or any specific risks to you. If you take part we will ask you about your health and well-being and any difficulties that you have experienced that led you to attend the hospital, so this may mean that you have to think about things that might be mildly upsetting. If this happens, the researcher will try to make sure that you are not left feeling upset. You will be able to contact the researcher by telephone afterwards if you need to. We do not think that taking part in this study could cause you any harm. In the unlikely event that you are harmed by taking part in the study, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a legal action, but you may have to pay your own legal costs.

Where is the study run from?
The study is run from the School of Psychology, Bangor University.

When is the study starting and how long is it expected to run for?
The study has been running since March 2010 and is expected to end in December 2013. We are expecting to recruit eligible participants until September 2013. However, this may change and it is advised to contact us.

Who is funding the study?
Economic and Social Research Council (ESRC)

Who is the main contact?
Mrs Kirstie Pye
k.pye@bangor.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Linda Clare

ORCID ID

Contact details

School of Psychology
The Brigantia Building
Penrallt Road
Bangor
LL57 2AS
United Kingdom
-
l.clare@bangor.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7988

Study information

Scientific title

Bilingualism as a protective factor in age-related neurodegenerative disorders: an observational cross-sectional study

Acronym

Study hypothesis

Various lifestyle factors are thought to reduce the risk of developing age-related conditions such as Alzheimer's disease (AD) and other dementias. Recent studies of people with AD suggest that people who are bilingual develop symptoms several years later than people who are monolingual. However, previous studies have left open the possibility that this effect may be due to other differences between groups.

This study aims to establish whether this delayed onset effect is robust by comparing bilinguals and monolinguals drawn from a population which is otherwise similar in social and cultural terms. It is also important to understand why this delayed onset effect arises. In general, people who are bilingual tend to outperform monolinguals in capacities such as planning or switching between different tasks. These capacities are called 'executive functions'. Executive functions become impaired in age-related conditions such as AD and Parkinson's Disease (PD).

This study aims to find out if people who are bilingual are more resilient in the face of impairments in executive functions when they develop these disorders. This will be achieved by comparing the performance of bilingual and monolingual healthy older people, people with AD, and people with PD on tests of executive function.

As of 12/06/2012, the target number of participants has been updated from 10 to 300. The study is recruiting 100 people with Alzheimer's Disease (50 monolingual English, 50 bilingual English-Welsh), 100 people with Parkinson's Disease (50 monolingual English, 50 bilingual English-Welsh) and 100 control participants (50 monolingual English, 50 bilingual English-Welsh).

Please note that as of 09/11/2012, the overall trial end date was changed from 01/11/2012 to 31/12/2013.

Ethics approval

Betsi Cadwaladr Health Board North West Wales Research Ethics Committee, 06/01/2010, ref: 10/WNO01/3

Study design

Multicentre observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Parkinson's Disease; Disease: Parkinson's disease, Dementia

Intervention

Current interventions as of 09/11/2012:
We will be seeing participants at one time-point, and asking participants questions about their language use, career, hobbies and activities throughout their lifespan. We will also ask participants to carry out paper and pencil measures such as linking numbers or letters, word tasks, repeating numbers, and some computer tasks. Visits tend to take an hour or so, approximately three times, but we tailor visits to participants' needs so if they prefer shorter visits we will carry out, for example, four visits, if preferable. There are no follow-up measures in this study.

Previous interventions until 09/11/2012:
We will be seeing participants at one time-point, and asking participants questions about their language use, career, hobbies and activities throughout their lifespan. We will also ask participants to carry out simple paper and pencil measures such as linking numbers or letters, word tasks, repeating numbers, and some simple computer tasks. Visits tend to take an hour or so, approximately three times, but we tailor visits to participants' needs so if they prefer shorter visits we will carry out, for example, four visits, if preferable. There are no follow-up measures in this study.

Intervention type

Other

Phase

Phase II/III

Drug names

Primary outcome measures

Knowledge, measured continuously throughout the study

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/2010

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Fluency in English
2. Ability to give informed consent
3. Fluency in Welsh (if bilingual)
4. Aged over 18 years, either sex

Healthy controls only:
5. Intact cognitive function as indicated by a Mini-Mental State Examination (MMSE) core of 26 or above

Participants with AD/PD only:
6. Medical diagnosis of AD/PD
7. Mini-mental state examination (MMSE) score of 18 or above
8. Availability of an informant

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Fluency in a language other than Welsh and/or English
2. History of brain injury, neurological disorder, neurodegenerative disorder (other than AD/PD) schizophrenia or other significant mental health problems
3. Major depression (current)
4. Lack of capacity to give consent

Recruitment start date

01/04/2010

Recruitment end date

01/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bangor University
Bangor
LL57 2AS
United Kingdom

Sponsor information

Organisation

Bangor University (UK)

Sponsor details

School of Psychology
The Brigantia Building
Penrallt Road
Bangor
LL57 2AS
United Kingdom

Sponsor type

University/education

Website

http://www.bangor.ac.uk

Funders

Funder type

Research council

Funder name

Economic and Social Research Council (ESRC) (UK) (ref: RES-062-23-1931)

Alternative name(s)

ESRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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