Southend Imaging Study

Study Overview
=================
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.

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.

Official Title
-----------------
Southend Imaging Study

Conditions
-----------------
Cognition Disorders

Intervention / Treatment
-----------------
* Other: fMRI
* Other: Neuropsychological tests


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Controls<br>Medical History, Neuropsychological tests, clinical assessments, fMRI | Other: fMRI<br>* Functional MRI scan to be performed<br>Other: Neuropsychological tests<br>* Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.<br>|
| Cognitive impairment<br>Medical History, Neuropsychological tests, clinical assessments, fMRI | Other: fMRI<br>* Functional MRI scan to be performed<br>Other: Neuropsychological tests<br>* Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.<br>|

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 |