Condition category
Nervous System Diseases
Date applied
08/01/2015
Date assigned
12/01/2015
Last edited
11/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An area of research called "mnemic neglect" has shown that when given information that in some way threatens our self-concept (our own view of ourselves), we tend to remember less of this information later on. If we are told exactly the same information, but asked to imagine that it applies to someone else called "Chris", then we tend to remember more about it. These findings suggest that the amount of information that we remember often depends on the extent to which this information, then we can help them to remember more about it. This study will look at how mnemic neglect operates amongst people with dementia using research techniques which have already been used to study the phenomenon in people without dementia. If the findings are similar then we may be able to find better ways of talking to people with dementia about their illness.

Who can participate?
Patients with a diagnosis of Alzheimer's Disease, Vascular Dementia or a mixed form of these from memory clinics from three sites in South West England

What does the study involve?
Participants are asked to carry out a number of memory tests to examine:
Study A - recall of neutral versus illness related words
Study B - recall of negative and positive behavioural statements
Study C - recall of statements related to dementia
Participants taking part in in studies B and C are randomly allocated to one of two groups. Those in group 1 are asked to imagine the statements as “applies to yourself". Those in group 2 are asked to imagine that the statement “applies to someone called Chris”. Study A and B take roughly an hour to complete including consent and debrief. Study C takes around 50 minutes to complete including consent and debrief.

What are the possible benefits and risks of participating?
Advantages of taking part in the study include adding to scientific knowledge about dementia and how information about diagnosis is communicated. Disadvantages of taking part include memory tasks that may be upsetting or cause some participants to feel tired.

Where is the study run from?
University of the West of England, Bristol (UK)

When is the study starting and how long is it expected to run for?
December 2014 to October 2016

Who is funding the study?
Alzheimer's Society (UK)

Who is the main contact?
Miss Emily Dodd

Trial website

Contact information

Type

Scientific

Primary contact

Miss Emily Dodd

ORCID ID

http://orcid.org/0000-0002-9505-257X

Contact details

Frenchay Campus
University of the West of England
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom

Type

Scientific

Additional contact

Prof Richard Cheston

ORCID ID

http://orcid.org/0000-0002-7466-3777

Contact details

Frenchay Campus
University of the West of England
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17952

Study information

Scientific title

Mnemic neglect in people affected with mild Alzheimer's disease and dementia: replicating and extending findings from experimental social psychology

Acronym

Study hypothesis

There are three studies within this project, each with their own question:
Study A - do people with dementia show a preferential recall of neutral rather than illness-related words? Study B - do people with dementia show mnemic neglect?
Study C - is there a bias towards recall descriptions of dementia for the self, compared to descriptions of dementia relating to others?

Ethics approval

NRES Committee South West – Frenchay, 18/12/2014, ref: 14/SW/1142

Study design

Both; Interventional and Observational; Design type: Not specified, Case-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Topic: Dementias and neurodegeneration; Subtopic: Dementia; Disease: Dementia

Intervention

Participants have either been diagnosed with a form of dementia or are healthy volunteers (control group). Participants are asked to carry out a number of memory tests to examine:
Study A - recall of neutral versus illness related words
Study B - recall of negative and positive behavioural statements
Study C - recall of statements related to dementia

Study A is a simple memory test of words with no randomisation, everyone gets the same word list. Participants taking part in in studies B and C are randomly allocated to one of two groups. Those in group 1 are asked to imagine the statements as “applies to yourself". Those in group 2 are asked to imagine that the statement “applies to someone called Chris”. Study A and B take roughly an hour to complete including consent and debrief. Study C takes around 50 minutes to complete including consent and debrief.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 11/01/2017:
Study A: the mean number of dementia and non-dementia words recalled
Study B: the mean number of behaviour statements recalled (central or peripheral and positive or negative)
Study C: the mean number of high threat and low threat dementia statements recalled
There was only one timepoint to this study, the research appointment lasted up to an hour and the method was to simply count up the number of correct words/behaviours/statements recalled or recognised by each participant

Previous primary outcome measures:
Number of words, statements, descriptions recalled:
1. Straight after presentation
2. After a 2 minute delay

Secondary outcome measures

Current secondary outcome measures as of 11/01/2017:
All three studies: recognition scores and intrusion errors
There was only one timepoint to this study, the research appointment lasted up to an hour and method was to simply count up the number of correct words/behaviours/statements recalled or recognised by each participant

Previous secondary outcome measures:
Recognition of words, statements and descriptions after recall tasks:
1. Straight after presentation
2. After a 2 minute delay

Overall trial start date

01/12/2014

Overall trial end date

01/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis made within the previous 18 months by a consultant psychiatrist of either probable Alzheimer’s disease according to the NINCDS-ADRDA criteria (McKhann et al, 1984) or probable vascular dementia according to the NINDS-­IREN criteria (Román et al, 1993) or a mixed form of these
2. Mild levels of cognitive impairment (e.g. MOCA score over 12 or equivalent score on an alternative assessment tool)
3. The capacity to consent to be part of the research
4. Sufficient communication skills to be able to take part in the research

Control group:
Healthy volunteers recruited from Join Dementia Research (JDR) register, students and staff at the University of the West of England

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 110; UK Sample Size: 110; Description: 50 participants will be recruited in study A and B from RICE memory clinic; 60 participants will be recruited to study C from AWP and Devon Partnership memory clinics

Participant exclusion criteria

1. They have a significant history of pre-­morbid psychiatric problems
2. They have a diagnosis of dementia with Lewy Bodies (McKeith, 2002) or frontal­-temporal dementia (Snowden, Neary and Mann (2002)
3. If deficits in short-­term memory are not a primary cause of disability

Recruitment start date

01/02/2015

Recruitment end date

31/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of the West of England, Bristol
Faculty of Health & Life Sciences Glenside Campus Blackberry Hill
Bristol
BS16 1DD
United Kingdom

Sponsor information

Organisation

University of the West of England, Bristol

Sponsor details

Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Alzheimer's Society

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

Findings will be published in peer-reviewed journals at the end of the study. A preliminary survey conducted on the general population was used to generate and validate the descriptions used in study C. The results of this will be published. Participants will receive a written lay summary of the findings.

IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/07/2017

Participant level data

To be made available at a later date

Results - basic reporting

See additional file ISRCTN30485698_BasicResults_15Nov16.docx

Publication summary

Publication citations

Additional files

Editorial Notes

11/01/2017: the following changes were made to the trial record: 1. The overall trial end date was changed from 30/11/2015 to 01/10/2016. 2. A basic results summary was added.