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Southend Imaging Study (SIS)

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ClinicalTrials.gov Identifier: NCT02736396
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : December 14, 2016
Sponsor:
Collaborator:
Anglia Ruskin University
Information provided by (Responsible Party):
Southend University Hospital Foundation NHS Trust

Brief 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.

Condition or disease Intervention/treatment
Cognition Disorders Other: fMRI Other: Neuropsychological tests

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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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Southend Imaging Study
Study Start Date : June 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : April 2020

Group/Cohort Intervention/treatment
Healthy Controls
Medical History, Neuropsychological tests, clinical assessments, fMRI
Other: fMRI
Functional MRI scan to be performed

Other: Neuropsychological tests
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
Other: fMRI
Functional MRI scan to be performed

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




Primary Outcome Measures :
  1. Evaluation of the functional connectivity in the Default Mode Network . [ Time Frame: 4 years ]
    Evaluating the correlation of the Default Mode Network functional connectivity to types of dementia.


Secondary Outcome Measures :
  1. Correlation of cognitive performance to functional connectivity. [ Time Frame: 4 years ]
    To evaluate the correlation between individual measures of functional connectivity and global and episodic cognitive performance as measured by neuropsychological tests.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736396


Contacts
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Contact: Susan A Bowman 01702 385342 susan.bowman@southend.nhs.uk
Contact: Craig Mackerness, Dr 01702 385089 craig.mackerness@southend.nhs.uk

Locations
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United Kingdom
Southend University Hospital NHS Foundation Trust Recruiting
Westcliff on Sea, Essex, United Kingdom, SS0 0RY
Contact: Paula Harman    01702 435555 ext 8485    paula.harman@southend.nhs.uk   
Contact: Susan Bowman    01702 385342    susan.bowman@southend.nhs.uk   
Sponsors and Collaborators
Southend University Hospital Foundation NHS Trust
Anglia Ruskin University
Investigators
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Principal Investigator: Paula A Harman, BSc Southend University Hospital NHS Foundation Trust

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Responsible Party: Southend University Hospital Foundation NHS Trust
ClinicalTrials.gov Identifier: NCT02736396     History of Changes
Other Study ID Numbers: P0867
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cognition Disorders
Neurocognitive Disorders
Mental Disorders