Southend Imaging Study
SIS
1 other identifier
observational
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedDecember 22, 2020
December 1, 2020
3.4 years
March 8, 2016
December 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Correlation of cognitive performance to functional connectivity.
4 years
Study Arms (2)
Healthy Controls
Medical History, Neuropsychological tests, clinical assessments, fMRI
Cognitive impairment
Medical History, Neuropsychological tests, clinical assessments, fMRI
Interventions
Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mid and South Essex NHS Foundation Trustlead
- Anglia Ruskin Universitycollaborator
Study Sites (1)
Southend Hospital
Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paula A Harman, BSc
Southend University Hospital NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2016
First Posted
April 13, 2016
Study Start
June 1, 2016
Primary Completion
November 1, 2019
Study Completion
September 1, 2020
Last Updated
December 22, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share