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CompletedNCT02736396SISUpdated Dec 22, 2020

Southend Imaging Study

An observational study in Cognition Disorders, sponsored by Mid and South Essex NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-22.

Sponsored by Mid and South Essex NHS Foundation Trust · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
37
Ages
18 Years to 100 Years
Sex
All
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Study summary

The study objective is to correlate global cognition and episodic memory performance to resting state fMRI functional connectivity. This is a non-treatment, prospective, natural history data collection study in a cross-sectional cohort of patients with cognitive impairment.

Read the detailed description

At present, Magnetic Resonance Imaging (MRI) is widely used along with other tests to help diagnose dementia, however diagnosis still remains challenging. There is currently a focus on the usefulness of resting state functionalMRI (RS fMRI) as a way of establishing differences in functional connectivity between healthy subjects and those with various neurodegenerative disorders. Although the potential for RS fMRI to be used as a biomarker for neurological diseases looks promising, further research is needed, especially regarding validation of normal values and seed-based functional connectivity. Further research into this area will help to improve the ability to appropriately classify new subjects and ultimately allow use of RS functional connectivity as a biomarker. This is a nontreatment, prospective, natural history data collection that aims to analyse functional connectivity in a cohort of patients with suspected cognitive impairment. Correlation of global cognition and episodic memory performance to resting state fMRI functional connectivity will be evaluated. Patient population will include patients over the age of 18 with cognitive impairment and age and gender matched controls. Eligible patients will have to complete neuropsychological and clinical assessments and complete an fMRI scan prior to enrolment.Study duration is estimated at 4 years.

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Conditions studied

  • Cognition Disorders

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03

In context

Cognition Disorders

411 studies on the registry are indexed under Cognition Disorders; 90 are open to participants now.

This study's enrollment of 37 is below the median of 173 across 107 observational studies indexed under Cognition Disorders.

Browse Cognition Disorders studies →

Lead sponsor

Mid and South Essex NHS Foundation Trust is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with suspected cognitive impairment, mild cognitive impairment, autosomal dominant Alzheimer's disease, late onset Alzheimer's disease, Vascular dementia, Parkinson's dementia and age and gender matched controls.

Inclusion criteria

  • Informed consent
  • Cognitive impairment
  • Age from 18 to 100 years
  • On stable medication for 1 month before the screening visit; on or off cholinesterase inhibitors
  • Fluency in English and adequate premorbid intellectual functioning

Exclusion criteria

Exclusion Criteria:

  • Any contraindication to MRI scanning
  • Clinically significant psychiatric disorder (e.g. depression)
  • Current clinically significant illness that could confound the results of the study
  • History of alcohol or drug dependence or abuse
  • Current use of anticonvulsant or narcotic medications.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy Controls

    Medical History, Neuropsychological tests, clinical assessments, fMRI

    Other: fMRI · Other: Neuropsychological tests

  • Cognitive impairment

    Medical History, Neuropsychological tests, clinical assessments, fMRI

    Other: fMRI · Other: Neuropsychological tests

Interventions

  • OtherfMRI

    Functional MRI scan to be performed

  • OtherNeuropsychological tests

    Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.

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What researchers measure

Primary outcomes

  1. Evaluation of the functional connectivity in the Default Mode Network .

    Evaluating the correlation of the Default Mode Network functional connectivity to types of dementia.

    Time frame: 4 years

Secondary outcomes

  1. Correlation of cognitive performance to functional connectivity.

    To evaluate the correlation between individual measures of functional connectivity and global and episodic cognitive performance as measured by neuropsychological tests.

    Time frame: 4 years

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Study locations

1 site
  • Southend Hospital
    Westcliff on Sea, Essex SS0 0RY, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02736396
Lead sponsor
Mid and South Essex NHS Foundation Trust
Collaborators
Anglia Ruskin University
Responsible party
Sponsor
First posted
Apr 13, 2016
Start date
Jun 2016
Primary completion
Nov 2019
Completion
Sep 2020
Last update
Dec 22, 2020

Study contacts

Paula A Harman, BSc
principal investigator · Southend University Hospital NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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