Southend Imaging Study

Cognition Disorders Clinical Trial

— SIS  

Official title:

Southend Imaging Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736396
• Other study ID #: P0867
• Status: Completed
• Start date: June 2016
• Est. completion date: September 2020

Study information

• Verified date: December 2020
• Source: Mid and South Essex NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition Disorders

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Southend Hospital	Westcliff on Sea	Essex

Sponsors (2)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust	Anglia Ruskin University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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