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Southend Imaging Study

Southend Imaging Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02736396
Acronym
SIS
Enrollment
37
Registered
2016-04-13
Start date
2016-06-30
Completion date
2020-09-30
Last updated
2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition Disorders

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.

Interventions

OTHERfMRI

Functional MRI scan to be performed

OTHERNeuropsychological tests

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

Sponsors

Anglia Ruskin University
CollaboratorOTHER
Mid and South Essex NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the functional connectivity in the Default Mode Network .4 yearsEvaluating the correlation of the Default Mode Network functional connectivity to types of dementia.

Secondary

MeasureTime frameDescription
Correlation of cognitive performance to functional connectivity.4 yearsTo evaluate the correlation between individual measures of functional connectivity and global and episodic cognitive performance as measured by neuropsychological tests.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026