Automated Brain Morphometry for Dementia Diagnosis

Dementia Clinical Trial

— BrainMeasure  

Official title:

Automated Brain Morphometry for Dementia Diagnosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02286505
• Other study ID #: 101353
• Status: Not yet recruiting
• Phase: N/A
• First received: November 5, 2014
• Last updated: November 5, 2014
• Start date: November 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2014
• Source: King's College London
• Contact: Sergi G Costafreda-Gonzalez, MD, PhD
• Phone: +442078485862
• Email: sergi.1.costafreda[@]kcl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Department of HealthUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 51 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dementia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Old Age Psychiatry and Dementia Clinical Academic Group, South London and Maudsley NHS Foundation Trust and King's College London	London

Sponsors (5)

Lead Sponsor	Collaborator
King's College London	Cambridge Cognition Ltd, Imperial College London, IXICO Limited, University of Sussex

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to treatment	Time to prescription of symptomatic treatment (cholinesterase inhibitors or memantine) in patients with and without the brain morphometry analysis.	12 weeks	No
Other	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	No
Primary	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	No
Secondary	Time to diagnosis.	Comparing time from referral to diagnosis in patients with and without brain morphometry.	12 weeks	No