Automated Brain Morphometry for Dementia Diagnosis (BrainMeasure)

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.

Study Overview

• Status: Unknown
• Conditions: Dementia
• Intervention / Treatment: Device: Brain Morphometry; Other: Standard radiological assessment

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergi G Costafreda-Gonzalez, MD, PhD; Phone Number: +442078485862; Email: sergi.1.costafreda@kcl.ac.uk
• Study Contact Backup: Name: Natalie N Gottlieb, BSc; Phone Number: +442079193084; Email: natalie.n.gottlieb@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 8AF
    • Old Age Psychiatry and Dementia Clinical Academic Group, South London and Maudsley NHS Foundation Trust and King's College London
    • Contact: Natalie N Gottlieb, BSc; Phone Number: +4420V79193084; Email: natalie.n.gottlieb@kcl.ac.uk
    • Principal Investigator: Sergi Costafreda-Gonzalez, MD, PhD
    • Sub-Investigator: Natalie N Gottlieb, BSc
    • Principal Investigator: Andy Simmons, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment	Time to prescription of symptomatic treatment (cholinesterase inhibitors or memantine) in patients with and without the brain morphometry analysis.	12 weeks
Patient and carer satisfaction	Satisfaction in the diagnostic process as measured by questionnaire administered at time of final diagnosis to patient and carer, if available.	12 weeks

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Imperial College London; Cambridge Cognition Ltd; University of Sussex; IXICO Limited
• Investigators: Principal Investigator: Sergi Costafreda-Gonzalez, MD, PhD, King's College London; Principal Investigator: Andrew Simmons, PhD, King's College London

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Estimate): November 7, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 101353