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AzTrials

Cognitive ImpairmentNCT03335696

Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy

An observational study of Cognitive Impairment and Dementia, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
800 participants
Where
1 siteUnited Kingdom
Study dates
1 Jan 2012to 30 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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).

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University of Oxford

    Oxford, England, OX3 7JX

Other trials in United Kingdom

About this study

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.

Read the 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.

Keywords
Epidemiology, Magnetic resonance imaging, Diffusion tensor imaging, White matter, Functional MRI, Connectome, Resting state brain networks, Neuropsychology
Medical subject headings
Cognitive Dysfunction, Dementia, Mood Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropsychological measure 1

    National Adult Reading Test (premorbid intellectual ability)

    Measured: 2012-2016

  2. Neuropsychological measure 2

    Montreal Cognitive Assessment (MoCA)

    Measured: 2012-2016

  3. Neuropsychological measure 3

    Rey Complex Figure copy and delayed recall (visual episodic memory)

    Measured: 2012-2016

  4. Neuropsychological measure 4

    Hopkins Verbal Learning Test Revised (verbal episodic memory)

    Measured: 2012-2016

  5. Neuropsychological measure 5

    CANTAB Simple and Choice Reaction Time (processing speed)

    Measured: 2012-2016

  6. Neuropsychological measure 6

    WAIS-R Digit Symbol Test (processing speed)

    Measured: 2012-2016

  7. Neuropsychological measure 7

    Trail Making Test A and B (processing speed/executive functioning)

    Measured: 2012-2016

  8. Neuropsychological measure 8

    WAIS-R Digit Span forward and backwards (executive functioning)

    Measured: 2012-2016

  9. Neuropsychological measure 9

    Graded Naming Test (semantic memory)

    Measured: 2012-2016

  10. MRI Measures 1

    Siemens 3T - T1-weighted scan (MPRAGE) using FSL FIRST, FAST, and Freesurfer Volume extractions

    Measured: 2012-2016

  11. MRI Measures 2

    Siemens 3T - T1-weighted scan (MPRAGE) using FSL GLM Voxel based analysis for grey matter density analysis

    Measured: 2012-2016

  12. MRI Measures 3

    Siemens 3T - T2-weighted scan, clinical and FSL (BIANCA)-based rating of white matter changes

    Measured: 2012-2016

  13. MRI Measures 4

    Siemens 3T Diffusion Tensor Images analyzed with Tract Based Spatial Statistics (TBSS)

    Measured: 2012-2016

  14. MRI Measures 5

    Siemens 3T rs-fMRI analyzed with Multivariate Exploratory Linear Optimized Decomposition into Independent Components: MELODIC)

    Measured: 2012-2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start1 Jan 2012
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03335696
Sponsor's protocol ID
MSD/IDREC/C1/2011/71
Status last verified
Nov 2017
First submitted
29 Sep 2017
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study follows MRC data sharing policies. Data will be accessible from the authors after 2019.

Publications

  • 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, Salimi-Khorshidi G, Sotiropoulos SN, Voets NL, Smith SM, Geddes JR, Singh-Manoux A, Mackay CE, Kivimaki M, Ebmeier KP. Study protocol: The Whitehall II imaging sub-study. BMC Psychiatry. 2014 May 30;14:159. doi: 10.1186/1471-244X-14-159.

    PubMed 24885374

  • 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. Br J Psychiatry. 2015 Apr;206(4):308-15. doi: 10.1192/bjp.bp.114.153536. Epub 2014 Dec 11.

    PubMed 25497301

  • 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. doi: 10.1192/bjp.bp.114.152363. Epub 2015 Sep 3.

    PubMed 26338988

  • 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 Affect Disord. 2016 Nov 1;204:219-25. doi: 10.1016/j.jad.2016.06.049. Epub 2016 Jun 21.

    PubMed 27372409

  • 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 hyperintensities on MRI: A study in older adults. Neuroimage. 2018 Apr 15;170:174-181. doi: 10.1016/j.neuroimage.2017.03.024. Epub 2017 Mar 15.

    PubMed 28315460

  • 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 May 15;152:509-516. doi: 10.1016/j.neuroimage.2017.03.031. Epub 2017 Mar 18.

    PubMed 28323160

  • 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 study. BMJ. 2017 Jun 6;357:j2353. doi: 10.1136/bmj.j2353.

    PubMed 28588063

  • 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 community-dwelling older adults: A prospective cohort study. Hum Brain Mapp. 2017 Nov;38(11):5465-5473. doi: 10.1002/hbm.23739. Epub 2017 Jul 26.

    PubMed 28745016

  • 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 Oct 1;159:122-130. doi: 10.1016/j.neuroimage.2017.07.049. Epub 2017 Jul 26.

    PubMed 28756237

  • 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 older adults. PLoS One. 2017 Aug 3;12(8):e0181392. doi: 10.1371/journal.pone.0181392. eCollection 2017.

    PubMed 28771482

  • Patel R, Mackay CE, Jansen MG, Devenyi GA, O'Donoghue MC, Kivimaki M, Singh-Manoux A, Zsoldos E, Ebmeier KP, Chakravarty MM, Suri S. Inter- and intra-individual variation in brain structural-cognition relationships in aging. Neuroimage. 2022 Aug 15;257:119254. doi: 10.1016/j.neuroimage.2022.119254. Epub 2022 Apr 28.

    PubMed 35490915

  • Jansen MG, Griffanti L, Mackay CE, Anaturk M, Melazzini L, Lange AG, Filippini N, Zsoldos E, Wiegertjes K, Leeuw FE, Singh-Manoux A, Kivimaki M, Ebmeier KP, Suri S. Association of cerebral small vessel disease burden with brain structure and cognitive and vascular risk trajectories in mid-to-late life. J Cereb Blood Flow Metab. 2022 Apr;42(4):600-612. doi: 10.1177/0271678X211048411. Epub 2021 Oct 5.

    PubMed 34610763

  • Suri S, Chiesa ST, Zsoldos E, Mackay CE, Filippini N, Griffanti L, Mahmood A, Singh-Manoux A, Shipley MJ, Brunner EJ, Kivimaki M, Deanfield JE, Ebmeier KP. Associations between arterial stiffening and brain structure, perfusion, and cognition in the Whitehall II Imaging Sub-study: A retrospective cohort study. PLoS Med. 2020 Dec 29;17(12):e1003467. doi: 10.1371/journal.pmed.1003467. eCollection 2020 Dec.

    PubMed 33373359

  • Zsoldos E, Mahmood A, Filippini N, Suri S, Heise V, Griffanti L, Mackay CE, Singh-Manoux A, Kivimaki M, Ebmeier KP. Association of midlife stroke risk with structural brain integrity and memory performance at older ages: a longitudinal cohort study. Brain Commun. 2020 Mar 7;2(1):fcaa026. doi: 10.1093/braincomms/fcaa026. eCollection 2020.

    PubMed 32954286

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Impairment and Dementia, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuropsychological measure 1 (time frame: 2012-2016). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03335696, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023; AzTrials last refreshed its copy on 2 Nov 2026.

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