Cognition DisordersSISNCT02736396
Southend Imaging Study
An observational study of Cognition Disorders, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorders
- What is being tested?
- fMRI and Neuropsychological tests
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southend Hospital
Westcliff-on-Sea, Essex, SS0 0RY
About this study
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.
Read the 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.
- Conditions
- Cognition Disorders
- Being tested
- fMRI, Neuropsychological tests
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Functional MRI scan to be performed
Neuropsychological testsOther
Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Medical History, Neuropsychological tests, clinical assessments, fMRI Receives: Other: fMRI; Other: Neuropsychological tests | |
| Cognitive impairment | Medical History, Neuropsychological tests, clinical assessments, fMRI Receives: Other: fMRI; Other: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the functional connectivity in the Default Mode Network .
Evaluating the correlation of the Default Mode Network functional connectivity to types of dementia.
Measured: 4 years
Secondary outcomes (1)
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University
- Responsible party
- Sponsor
- Investigators
- Paula A Harman, BSc, Principal investigator, Southend University Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736396
- Sponsor's protocol ID
- P0867
- Acronym
- SIS
- Status last verified
- Dec 2020
- First submitted
- 8 Mar 2016
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southend Imaging Study
- ClinicalTrials.gov ID
- NCT02736396
- Acronym / sponsor ID
- SIS / P0867
- Conditions
- Cognition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Anglia Ruskin University
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Other: fMRI, Other: Neuropsychological testsMedical History, Neuropsychological tests, clinical assessments, fMRI |
| Cognitive impairment | – | Other: fMRI, Other: Neuropsychological testsMedical History, Neuropsychological tests, clinical assessments, fMRI |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIFunctional MRI scan to be performed | Other | Cognitive impairment, Healthy Controls |
| Neuropsychological testsCognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment. | Other | Cognitive impairment, Healthy Controls |
Primary outcome
Evaluation of the functional connectivity in the Default Mode Network .
Time frame: 4 years
Evaluating the correlation of the Default Mode Network functional connectivity to types of dementia.
1 secondary outcome
Correlation of cognitive performance to functional connectivity.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula A Harman, BSc principal investigator
Southend University Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition Disorders, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the functional connectivity in the Default Mode Network . (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.