Automated Brain Morphometry for Dementia Diagnosis
BrainMeasure
1 other identifier
interventional
80
1 country
1
Brief Summary
Early dementia diagnosis improves patient and carer experience, links them to appropriate care and support and enables timely symptomatic treatment. The guidelines of the UK National Institute for Health and Care Excellence recommend brain Magnetic resonance imaging (MRI) to assist with the diagnosis in suspected dementia. Recently, computerised analysis of MRI scans, also known as automated brain morphometry, has shown potential to detect the brain changes characteristic of early dementia, and may therefore be a useful addition to the standard reporting performed by a neuroradiologist. The present pilot study will assess whether adding brain morphometric analysis to the usual diagnostic pathway improve diagnosis in clinical practice as an addition to the existing diagnostic pathway in a memory clinic setting. The main purpose of the study is to compare measures of the clinicians diagnostic confidence in patients with and without brain morphometry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
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
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedNovember 7, 2014
November 1, 2014
1.3 years
November 5, 2014
November 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in confidence in the clinical diagnosis
Difference in confidence of the clinical diagnosis between the two arms of the trial (patient with and without quantitative brain morphometric analysis). This is a number for each subject ranging from 1 (not at all confident) to 5 (extremely confident), as measured by a questionnaire completed by the clinician at the time of final diagnosis.
12 weeks
Secondary Outcomes (1)
Time to diagnosis.
12 weeks
Other Outcomes (2)
Time to treatment
12 weeks
Patient and carer satisfaction
12 weeks
Study Arms (2)
Brain Morphometry
EXPERIMENTALQuantitative, automated reading of hippocampal volume from MRI scans, complemented by a general measure of brain atrophy, in addition to standard neuroradiological report.
Standard radiological assessment.
OTHERStandard neuroradiological report of the structural MRI only.
Interventions
Quantitative, automated reading of hippocampal volume from MRI scans, complemented by a general measure of brain atrophy, in addition to standard neuroradiological report.
Standard neuroradiological report produced by qualitative examination of structural MRI scan by trained neuroradiologist.
Eligibility Criteria
You may qualify if:
- Subjects referred to a South London and Maudsley (SLaM) memory clinic for suspected dementia.
- Cognitive scores (standardised MMSE of 15 or more inclusive) and impairment in activities of daily living consistent with a diagnosis of mild to moderate dementia or mild cognitive impairment.
- Working knowledge of English.
- Must consent to the imaging and follow-up aspects of the study. If the patient lacks capacity to consent to the study, they will not be invited to participate.
- If the patient has a partner or carer able to provide an independent evaluation of functioning and able and willing to be involved in a follow-up interview about their experience of the diagnostic process, the carer should also consent to participate in the study.
You may not qualify if:
- Contraindications for MRI
- Patients 50 or younger (cognitive impairment in this younger population is only exceptionally due to a neurodegenerative condition). There are no upper age limits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- Imperial College Londoncollaborator
- University of Sussexcollaborator
- IXICO Limitedcollaborator
- Cambridge Cognition Ltdcollaborator
Study Sites (1)
Old Age Psychiatry and Dementia Clinical Academic Group, South London and Maudsley NHS Foundation Trust and King's College London
London, London, SE5 8AF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergi Costafreda-Gonzalez, MD, PhD
King's College London
- PRINCIPAL INVESTIGATOR
Andrew Simmons, PhD
King's College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 7, 2014
Study Start
November 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
November 7, 2014
Record last verified: 2014-11