Condition category
Mental and Behavioural Disorders
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
05/02/2016
Prospective/Retrospective
Retrospectively 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

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
-
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 Alzheimer’s disease (AD) in older people, and includes dementia with Lewy bodies (DLB) and Parkinson’s 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 below 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

http://www.ntw.nhs.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 088441)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

05/02/2016: No publications found, verifying study status with principal investigator