Automated Brain Morphometry for Dementia Diagnosis

NCT ID: NCT02286505

Last Updated: 2014-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-03-31

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.

Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Brain Morphometry

Intervention Type DEVICE

Quantitative, 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

Intervention Type OTHER

Standard neuroradiological report produced by qualitative examination of structural MRI scan by trained neuroradiologist.

Standard radiological assessment.

Standard neuroradiological report of the structural MRI only.

Group Type OTHER

Standard radiological assessment

Intervention Type OTHER

Standard neuroradiological report produced by qualitative examination of structural MRI scan by trained neuroradiologist.

Interventions

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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.

Intervention Type DEVICE

Standard radiological assessment

Standard neuroradiological report produced by qualitative examination of structural MRI scan by trained neuroradiologist.

Intervention Type OTHER

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.
Minimum Eligible Age

51 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role collaborator

University of Sussex

OTHER

Sponsor Role collaborator

IXICO Limited

UNKNOWN

Sponsor Role collaborator

Cambridge Cognition Ltd

INDUSTRY

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergi Costafreda-Gonzalez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Andrew Simmons, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Old Age Psychiatry and Dementia Clinical Academic Group, South London and Maudsley NHS Foundation Trust and King's College London

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Sergi G Costafreda-Gonzalez, MD, PhD

Role: CONTACT

+442078485862

Natalie N Gottlieb, BSc

Role: CONTACT

+442079193084

Facility Contacts

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Natalie N Gottlieb, BSc

Role: primary

+4420V79193084

Other Identifiers

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101353

Identifier Type: -

Identifier Source: org_study_id