Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy

Dementia Clinical Trial

Official title:

Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335696
• Other study ID #: MSD/IDREC/C1/2011/71
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Affective Disorders
• Cognitive Impairment
• Dementia
• Mood Disorders

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford	England

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

Allan CL, Sexton CE, Filippini N, Topiwala A, Mahmood A, Zsoldos E, Singh-Manoux A, Shipley MJ, Kivimaki M, Mackay CE, Ebmeier KP. Sub-threshold depressive symptoms and brain structure: A magnetic resonance imaging study within the Whitehall II cohort. J — View Citation

Allan CL, Zsoldos E, Filippini N, Sexton CE, Topiwala A, Valkanova V, Singh-Manoux A, Tabak AG, Shipley MJ, Mackay C, Ebmeier KP, Kivimaki M. Lifetime hypertension as a predictor of brain structure in older adults: cohort study with a 28-year follow-up. B — View Citation

Filippini N, Zsoldos E, Haapakoski R, Sexton CE, Mahmood A, Allan CL, Topiwala A, Valkanova V, Brunner EJ, Shipley MJ, Auerbach E, Moeller S, Ugurbil K, Xu J, Yacoub E, Andersson J, Bijsterbosch J, Clare S, Griffanti L, Hess AT, Jenkinson M, Miller KL, Sa — View Citation

Griffanti L, Jenkinson M, Suri S, Zsoldos E, Mahmood A, Filippini N, Sexton CE, Topiwala A, Allan C, Kivimaki M, Singh-Manoux A, Ebmeier KP, Mackay CE, Zamboni G. Classification and characterization of periventricular and deep white matter hyperintensitie — View Citation

Heise V, Zsoldos E, Suri S, Sexton C, Topiwala A, Filippini N, Mahmood A, Allan CL, Singh-Manoux A, Kivimaki M, Mackay CE, Ebmeier KP. Uncoupling protein 2 haplotype does not affect human brain structure and function in a sample of community-dwelling olde — View Citation

Sexton CE, Zsoldos E, Filippini N, Griffanti L, Winkler A, Mahmood A, Allan CL, Topiwala A, Kyle SD, Spiegelhalder K, Singh-Manoux A, Kivimaki M, Mackay CE, Johansen-Berg H, Ebmeier KP. Associations between self-reported sleep quality and white matter in — View Citation

Suri S, Emir U, Stagg CJ, Near J, Mekle R, Schubert F, Zsoldos E, Mahmood A, Singh-Manoux A, Kivimaki M, Ebmeier KP, Mackay CE, Filippini N. Effect of age and the APOE gene on metabolite concentrations in the posterior cingulate cortex. Neuroimage. 2017 M — View Citation

Suri S, Topiwala A, Filippini N, Zsoldos E, Mahmood A, Sexton CE, Singh-Manoux A, Kivimaki M, Mackay CE, Smith S, Ebmeier KP. Distinct resting-state functional connections associated with episodic and visuospatial memory in older adults. Neuroimage. 2017 — View Citation

Topiwala A, Allan CL, Valkanova V, Zsoldos E, Filippini N, Sexton C, Mahmood A, Fooks P, Singh-Manoux A, Mackay CE, Kivimaki M, Ebmeier KP. Moderate alcohol consumption as risk factor for adverse brain outcomes and cognitive decline: longitudinal cohort s — View Citation

Topiwala A, Allan CL, Valkanova V, Zsoldos E, Filippini N, Sexton CE, Mahmood A, Singh-Manoux A, Mackay CE, Kivimaki M, Ebmeier KP. Resilience and MRI correlates of cognitive impairment in community-dwelling elders. Br J Psychiatry. 2015 Nov;207(5):435-9. — View Citation

Outcome

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

External Links

•   Cohort on Dementia Platform UK
•   Whitehall II (also known as the Stress and Health Study)
•   Whitehall Imaging Oxford