Automated Brain Morphometry for Dementia Diagnosis

Study Overview
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Brief Summary
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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.

Official Title
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Automated Brain Morphometry for Dementia Diagnosis

Conditions
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Dementia

Intervention / Treatment
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* Device: Brain Morphometry
* Other: Standard radiological assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain Morphometry<br>Quantitative, automated reading of hippocampal volume from MRI scans, complemented by a general measure of brain atrophy, in addition to standard neuroradiological report. | Device: Brain Morphometry<br>* Quantitative, automated reading of hippocampal volume from MRI scans, complemented by a general measure of brain atrophy, in addition to standard neuroradiological report.<br>Other: Standard radiological assessment<br>* Standard neuroradiological report produced by qualitative examination of structural MRI scan by trained neuroradiologist.<br>|
| Other: Standard radiological assessment.<br>Standard neuroradiological report of the structural MRI only. | Other: Standard radiological assessment<br>* Standard neuroradiological report produced by qualitative examination of structural MRI scan by trained neuroradiologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to diagnosis. | Comparing time from referral to diagnosis in patients with and without brain morphometry. | 12 weeks |