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Automated Brain Morphometry for Dementia Diagnosis (BrainMeasure)

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Brain Morphometry
Standard radiological assessment
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dementia

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Brain Morphometry

Standard radiological assessment.

Arm Description

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 of the structural MRI only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to diagnosis.
Comparing time from referral to diagnosis in patients with and without brain morphometry.

Full Information

First Posted
November 5, 2014
Last Updated
November 5, 2014
Sponsor
King's College London
Collaborators
Imperial College London, University of Sussex, IXICO Limited, Cambridge Cognition Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02286505
Brief Title
Automated Brain Morphometry for Dementia Diagnosis
Acronym
BrainMeasure
Official Title
Automated Brain Morphometry for Dementia Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Imperial College London, University of Sussex, IXICO Limited, Cambridge Cognition Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain Morphometry
Arm Type
Experimental
Arm Description
Quantitative, automated reading of hippocampal volume from MRI scans, complemented by a general measure of brain atrophy, in addition to standard neuroradiological report.
Arm Title
Standard radiological assessment.
Arm Type
Other
Arm Description
Standard neuroradiological report of the structural MRI only.
Intervention Type
Device
Intervention Name(s)
Brain Morphometry
Intervention Description
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
Other
Intervention Name(s)
Standard radiological assessment
Intervention Description
Standard neuroradiological report produced by qualitative examination of structural MRI scan by trained neuroradiologist.
Primary Outcome Measure Information:
Title
Difference in confidence in the clinical diagnosis
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time to diagnosis.
Description
Comparing time from referral to diagnosis in patients with and without brain morphometry.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Time to treatment
Description
Time to prescription of symptomatic treatment (cholinesterase inhibitors or memantine) in patients with and without the brain morphometry analysis.
Time Frame
12 weeks
Title
Patient and carer satisfaction
Description
Satisfaction in the diagnostic process as measured by questionnaire administered at time of final diagnosis to patient and carer, if available.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergi G Costafreda-Gonzalez, MD, PhD
Phone
+442078485862
Email
sergi.1.costafreda@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie N Gottlieb, BSc
Phone
+442079193084
Email
natalie.n.gottlieb@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergi Costafreda-Gonzalez, MD, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Simmons, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Old Age Psychiatry and Dementia Clinical Academic Group, South London and Maudsley NHS Foundation Trust and King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie N Gottlieb, BSc
Phone
+4420V79193084
Email
natalie.n.gottlieb@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Sergi Costafreda-Gonzalez, MD, PhD
First Name & Middle Initial & Last Name & Degree
Natalie N Gottlieb, BSc
First Name & Middle Initial & Last Name & Degree
Andy Simmons, PhD

12. IPD Sharing Statement

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Automated Brain Morphometry for Dementia Diagnosis

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