Automated Brain Morphometry for Dementia Diagnosis (BrainMeasure)

King's College London

Status: Unknown

Conditions: Dementia

Treatments: Other: Standard radiological assessment; Device: Brain Morphometry

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02286505

101353

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 51+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Brain Morphometry

Experimental group

Description:

Quantitative, automated reading of hippocampal volume from MRI scans, complemented by a general measure of brain atrophy, in addition to standard neuroradiological report.

Treatment:

Device: Brain Morphometry

Other: Standard radiological assessment

Standard radiological assessment.

Other group

Description:

Standard neuroradiological report of the structural MRI only.

Treatment:

Other: Standard radiological assessment