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NCT Number: NCT03335696

Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy

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.

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Key information

Conditions

Cognitive Impairment Affective Disorders Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mood Disorders Nervous System Diseases Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Oxford

Oxford, England, OX3 7JX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • University College, London

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2017
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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