Southend Imaging Study (SIS)

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.

Study Overview

• Status: Completed
• Conditions: Cognition Disorders
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United Kingdom
  • Essex
    • Westcliff on Sea, Essex, United Kingdom, SS0 0RY
      • Southend Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the functional connectivity in the Default Mode Network .	Evaluating the correlation of the Default Mode Network functional connectivity to types of dementia.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust
• Collaborators: Anglia Ruskin University
• Investigators: Principal Investigator: Paula A Harman, BSc, Southend University Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders
• Other Study ID Numbers: P0867

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO