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Southend Imaging Study

NCT ID: NCT02736396

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognition Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Controls

Medical History, Neuropsychological tests, clinical assessments, fMRI

fMRI

Intervention Type OTHER

Functional MRI scan to be performed

Neuropsychological tests

Intervention Type OTHER

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

Cognitive impairment

Medical History, Neuropsychological tests, clinical assessments, fMRI

fMRI

Intervention Type OTHER

Functional MRI scan to be performed

Neuropsychological tests

Intervention Type OTHER

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

Interventions

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fMRI

Functional MRI scan to be performed

Intervention Type OTHER

Neuropsychological tests

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anglia Ruskin University

OTHER

Sponsor Role collaborator

Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula A Harman, BSc

Role: PRINCIPAL_INVESTIGATOR

Southend University Hospital NHS Foundation Trust

Locations

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Southend Hospital

Westcliff-on-Sea, Essex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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P0867

Identifier Type: -

Identifier Source: org_study_id