Plain English Summary
Background and study aims
The two most common forms of memory loss in later life (dementia) are Alzheimer’s disease and Lewy body dementia. One big problem for people with Alzheimer’s disease and Lewy body dementia is that they often have difficulties with their powers of concentration and attention. In particular, patients with Lewy body dementia tend to fluctuate in their levels of confusion and are often quite drowsy. However, very little is known about what causes these fluctuations in attention and thinking ability and understanding more about them will help with the development of more effective treatments. Two techniques called functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) can be used to try and understand how the brain focuses attention on something. The fMRI involves lying in a scanner while images are taken of the brain showing which bits are active when someone concentrates or focuses their attention. EEG involves attaching special sensors on the head which measure the tiny electrical currents made by the brain when someone is thinking. The aim of this study is to use these techniques in people with Alzheimer’s disease and Lewy body dementia to try and understand how attention gets impaired in these conditions.
Who can participate?
Dementia patients and healthy volunteers aged 60 years and over
What does the study involve?
The study involves attending hospital on three occasions. At the first visit there is an assessment of general health and mood, some short memory and vision tests and some attention tests on a computer. This lasts about one and a half hours. At the second visit participants answer some questions about attention and concentration and there is a repeat of the attention tests from visit 1 followed by an fMRI scan during which the attention tests are repeated. This lasts about one and a half hours. At the third visit participants answer some questions about attention and concentration and there is a repeat of the attention tests from visit 1 followed by an EEG and some recordings of the muscle movements in the hands. This lasts about two and a half hours.
What are the possible benefits and risks of participating?
There is no direct benefit in participating. However, the information gathered may help improve the treatment of people with Alzheimer’s and Lewy Body Dementia. There are no known risks with the MRI scan and it is not painful. There is no radiation known to be associated with the scan. The only discomfort some people feel is of claustrophobia while in the scanner but the scan can be stopped at any time. Occasional side effects of the EEG include a headache, slight neck pain which goes when the procedure is complete, or some reddening of the skin on the head where the sensors are attached, which should disappear within half an hour of the sensor mesh being removed.
Where is the study run from?
Wolfson Research Centre (UK)
When is the study starting and how long is it expected to run for?
September 2010 to April 2013
Who is funding the study?
Wellcome Trust (UK)
Who is the main contact?
Dr John-Paul Taylor
John-paul.taylor@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr John-Paul Taylor
ORCID ID
Contact details
Third Floor
Biomedical Research Building
Newcastle University
Campus for Ageing & Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
-
John-paul.taylor@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8366; 088441
Study information
Scientific title
Investigating attentional function and cognitive fluctuations in Lewy body disease: a functional magnetic imaging and electrophysiology multicentre non-randomised observational diagnosis cross-sectional study
Acronym
CATFieLD study
Study hypothesis
Lewy body dementia (LBD) is the second commonest cause of dementia after Alzheimers disease (AD) in older people, and includes dementia with Lewy bodies (DLB) and Parkinsons disease with dementia (PDD). People with LBD suffer considerable disability and distress and can experience problems with movement control, visual hallucinations, and fluctuations in their ability to think clearly. Fluctuations are particularly common in LBD and this study seeks to understand their causes. We will look at changes in brain activity patterns of people with LBD by magnetic resonance (MR) imaging and electrical scalp recordings (encephalography or electroencephalogram [EEG]) while they are doing simple picture tasks. 24 DLB, 24 PDD, 24 AD patients and 24 age-matched controls will be included. These tests will tell us more about the causes of fluctuations in thinking ability and how brain activity goes wrong in LBD. It will also help us diagnose LBD better and earlier, and help develop effective treatments to improve the quality of life for people with LBD.
Ethics approval
Newcastle and North Tyneside 1 Research Ethics Committee, 13/05/2010, ref: 10/H0906/19
Study design
Multicentre non-randomised diagnosis cross-sectional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Dementia
Intervention
1. Diffusion tensor imaging to assess white matter integrity
2. Functional imaging: functional magnetic resonance imaging (fMRI) BOLD brain scan in response to the attention network task
3. High density electroencephalography while subjects perform attention network task
4. Structural imaging: Structural MR brain scan
Follow up length: 6 months
Study entry: registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Functional MR BOLD activations to attentional network task, measured at end of study
Secondary outcome measures
1. Diffusion tensor measures of white matter, measured at end of study
2. Spatio-temporal EEG activations to attentional network task, measured at end of study
Overall trial start date
01/09/2010
Overall trial end date
30/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. For dementia patients: that they meet defined clinical criteria for diagnosis of dementia (dementia with Lewy bodies, Parkinson's disease with dementia, or Alzheimer's dementia) and Mini-Mental State Examination (MMSE) test score of more than 12
2. For healthy controls: No history of psychiatric or neurological brain disease and MMSE score more than 26 and has capacity to consent to participate
3. All aged 60 years and above, either sex
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned sample size: 96; UK sample size: 96
Participant exclusion criteria
1. Contraindications for or unwillingness to undergo MR imaging
2. Severe dementia (MMSE score less than 12), as such subjects will have difficulty fully understanding the nature and extent of the proposed research
3. Presence of other severe or unstable medical illnesses
4. Subjects with a history of visual impairment secondary to glaucoma, cataract, or macular degeneration as this could affect the ability of subjects to perform the visual attention task with LBD
5. Medications: subjects on benzodiazepines, antipsychotics or anticonvulsants will not be included as these can effect the EEG activity patterns
Recruitment start date
01/09/2010
Recruitment end date
30/04/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Research Centre
Third Floor
Biomedical Research Building
Newcastle University
Campus for Ageing & Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
Sponsor information
Organisation
Northumbria Tyne and Wear NHS Foundation Trust (UK)
Sponsor details
St Nicholas Hospital
Gosforth
Newcastle upon Tyne
NE3 3XT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust (grant ref: 088441)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The datasets generated during and/or analysed during the current study are available upon request from Dr John-Paul Taylor (john-paul.taylor@newcastle.ac.uk). All data is anonymised and identifiable by study number. Consent was obtained from participants for information to be used in anonymised form in similar studies.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26705763