Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335696
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
Follow-up study within the Whitehall II study, selecting 800 participants for further neuropsychological, clinical and imaging (MRI) examinations to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes.

Condition or disease
Cognitive Impairment Dementia Affective Disorders

Detailed Description:
A total of 6035 civil servants participated in the WHII Phase 11 clinical examination in 2012-2013. A random sample of 800 of these participants was included in a sub-study comprising an MRI brain scan, a detailed clinical and cognitive assessment, and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures. Data collection for this sub-study started in 2012 and was completed by in 2016. The participants, for whom social and health records have been collected since 1985, were between 60-85 years of age at the time the MRI study started. The pre-specified clinical and cognitive assessment protocols, the state-of-the-art MRI sequences and latest pipelines for analyses of this sub-study have been published and are attached to this application.

Layout table for study information
Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017



Primary Outcome Measures :
  1. Neuropsychological measure 1 [ Time Frame: 2012-2016 ]
    National Adult Reading Test (premorbid intellectual ability)

  2. Neuropsychological measure 2 [ Time Frame: 2012-2016 ]
    Montreal Cognitive Assessment (MoCA)

  3. Neuropsychological measure 3 [ Time Frame: 2012-2016 ]
    Rey Complex Figure copy and delayed recall (visual episodic memory)

  4. Neuropsychological measure 4 [ Time Frame: 2012-2016 ]
    Hopkins Verbal Learning Test Revised (verbal episodic memory)

  5. Neuropsychological measure 5 [ Time Frame: 2012-2016 ]
    CANTAB Simple and Choice Reaction Time (processing speed)

  6. Neuropsychological measure 6 [ Time Frame: 2012-2016 ]
    WAIS-R Digit Symbol Test (processing speed)

  7. Neuropsychological measure 7 [ Time Frame: 2012-2016 ]
    Trail Making Test A and B (processing speed/executive functioning)

  8. Neuropsychological measure 8 [ Time Frame: 2012-2016 ]
    WAIS-R Digit Span forward and backwards (executive functioning)

  9. Neuropsychological measure 9 [ Time Frame: 2012-2016 ]
    Graded Naming Test (semantic memory)

  10. MRI Measures 1 [ Time Frame: 2012-2016 ]
    Siemens 3T - T1-weighted scan (MPRAGE) using FSL FIRST, FAST, and Freesurfer Volume extractions

  11. MRI Measures 2 [ Time Frame: 2012-2016 ]
    Siemens 3T - T1-weighted scan (MPRAGE) using FSL GLM Voxel based analysis for grey matter density analysis

  12. MRI Measures 3 [ Time Frame: 2012-2016 ]
    Siemens 3T - T2-weighted scan, clinical and FSL (BIANCA)-based rating of white matter changes

  13. MRI Measures 4 [ Time Frame: 2012-2016 ]
    Siemens 3T Diffusion Tensor Images analyzed with Tract Based Spatial Statistics (TBSS)

  14. MRI Measures 5 [ Time Frame: 2012-2016 ]
    Siemens 3T rs-fMRI analyzed with Multivariate Exploratory Linear Optimized Decomposition into Independent Components: MELODIC)


Biospecimen Retention:   Samples With DNA
White cells, buccal swabs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Randomly selected from phase 11 of the an occupational cohort recruited from 1985 for the Whitehall II study (Marmot M, Brunner E. Cohort Profile: the Whitehall II study. Int J Epidemiol 2005;34(2):251-6).
Criteria

Inclusion Criteria:

  • Member of Whitehall II cohort attending at UCL for phase 11

Exclusion Criteria:

  • Not suitable for MRI, travelling to Oxford, seriously physically ill

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335696


Locations
Layout table for location information
United Kingdom
University of Oxford
Oxford, England, United Kingdom, OX3 7JX
Sponsors and Collaborators
University of Oxford
University College, London
Investigators
Layout table for investigator information
Principal Investigator: Klaus P Ebmeier, MD University of Oxford
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03335696    
Other Study ID Numbers: MSD/IDREC/C1/2011/71
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study follows MRC data sharing policies. Data will be accessible from the authors after 2019.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: After 2019
Access Criteria: approval by data sharing committee
URL: https://www.mrc.ac.uk/research/policies-and-guidance-for-researchers/data-sharing/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Epidemiology
Magnetic resonance imaging
Diffusion tensor imaging
White matter
Functional MRI
Connectome
Resting state brain networks
Neuropsychology
Additional relevant MeSH terms:
Layout table for MeSH terms
Mood Disorders
Mental Disorders