Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy

Sponsor

University of Oxford (Other)

Overall Status

Completed

CT.gov ID

NCT03335696

Collaborator

University College, London (Other)

800

Enrollment

Location

65.9

Actual Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Jan 1, 2012

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Jun 30, 2017

Outcome Measures

Primary Outcome Measures

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