Clinical trial NCT02286505: Automated Brain Morphometry for Dementia Diagnosis
Official title: Automated Brain Morphometry for Dementia Diagnosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: University of Sussex
name: IXICO Limited
name: Cambridge Cognition Ltd
First posted: 2014-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Difference in confidence in the clinical diagnosis
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to diagnosis.
timeFrame: 12 weeks
Other outcomes:
measure: Time to treatment
timeFrame: 12 weeks
measure: Patient and carer satisfaction
timeFrame: 12 weeks
Locations:
city: London
country: United Kingdom
facility: Old Age Psychiatry and Dementia Clinical Academic Group, South London and Maudsley NHS Foundation Trust and King's College London
Study officials:
affiliation: King's College London
name: Sergi Costafreda-Gonzalez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Andrew Simmons, PhD
role: PRINCIPAL_INVESTIGATOR
References: