Contact information
Type
Scientific
Primary contact
Dr John-Paul Taylor
ORCID ID
Contact details
Wolfson Research Centre
Institute for Ageing and Health
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
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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 measures
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
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
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)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
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