Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy

November 28, 2023 updated by: University of Oxford
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Oxford, England, United Kingdom, OX3 7JX
        • University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological measure 1
Time Frame: 2012-2016
National Adult Reading Test (premorbid intellectual ability)
2012-2016
Neuropsychological measure 2
Time Frame: 2012-2016
Montreal Cognitive Assessment (MoCA)
2012-2016
Neuropsychological measure 3
Time Frame: 2012-2016
Rey Complex Figure copy and delayed recall (visual episodic memory)
2012-2016
Neuropsychological measure 4
Time Frame: 2012-2016
Hopkins Verbal Learning Test Revised (verbal episodic memory)
2012-2016
Neuropsychological measure 5
Time Frame: 2012-2016
CANTAB Simple and Choice Reaction Time (processing speed)
2012-2016
Neuropsychological measure 6
Time Frame: 2012-2016
WAIS-R Digit Symbol Test (processing speed)
2012-2016
Neuropsychological measure 7
Time Frame: 2012-2016
Trail Making Test A and B (processing speed/executive functioning)
2012-2016
Neuropsychological measure 8
Time Frame: 2012-2016
WAIS-R Digit Span forward and backwards (executive functioning)
2012-2016
Neuropsychological measure 9
Time Frame: 2012-2016
Graded Naming Test (semantic memory)
2012-2016
MRI Measures 1
Time Frame: 2012-2016
Siemens 3T - T1-weighted scan (MPRAGE) using FSL FIRST, FAST, and Freesurfer Volume extractions
2012-2016
MRI Measures 2
Time Frame: 2012-2016
Siemens 3T - T1-weighted scan (MPRAGE) using FSL GLM Voxel based analysis for grey matter density analysis
2012-2016
MRI Measures 3
Time Frame: 2012-2016
Siemens 3T - T2-weighted scan, clinical and FSL (BIANCA)-based rating of white matter changes
2012-2016
MRI Measures 4
Time Frame: 2012-2016
Siemens 3T Diffusion Tensor Images analyzed with Tract Based Spatial Statistics (TBSS)
2012-2016
MRI Measures 5
Time Frame: 2012-2016
Siemens 3T rs-fMRI analyzed with Multivariate Exploratory Linear Optimized Decomposition into Independent Components: MELODIC)
2012-2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

University College, London

Investigators

  • Principal Investigator: Klaus P Ebmeier, MD, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSD/IDREC/C1/2011/71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study follows MRC data sharing policies. Data will be accessible from the authors after 2019.

IPD Sharing Time Frame

After 2019

IPD Sharing Access Criteria

approval by data sharing committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: Whitehall II MRI
    Information comments: Apply for data to Dementia Platform UK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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