Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-06 @ 3:43 PM
Study NCT ID:
NCT02286505
Status:
UNKNOWN
Last Update Posted:
2014-11-07
First Post:
2014-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Brain Morphometry for Dementia Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-05', 'studyFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2014-11-05', 'lastUpdatePostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to treatment', 'timeFrame': '12 weeks', 'description': 'Time to prescription of symptomatic treatment (cholinesterase inhibitors or memantine) in patients with and without the brain morphometry analysis.'}, {'measure': 'Patient and carer satisfaction', 'timeFrame': '12 weeks', 'description': 'Satisfaction in the diagnostic process as measured by questionnaire administered at time of final diagnosis to patient and carer, if available.'}], 'primaryOutcomes': [{'measure': 'Difference in confidence in the clinical diagnosis', 'timeFrame': '12 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Time to diagnosis.', 'timeFrame': '12 weeks', 'description': 'Comparing time from referral to diagnosis in patients with and without brain morphometry.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '51 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects referred to a South London and Maudsley (SLaM) memory clinic for suspected dementia.\n* 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.\n* Working knowledge of English.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Contraindications for MRI\n* Patients 50 or younger (cognitive impairment in this younger population is only exceptionally due to a neurodegenerative condition). There are no upper age limits.'}, 'identificationModule': {'nctId': 'NCT02286505', 'acronym': 'BrainMeasure', 'briefTitle': 'Automated Brain Morphometry for Dementia Diagnosis', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Automated Brain Morphometry for Dementia Diagnosis', 'orgStudyIdInfo': {'id': '101353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain Morphometry', 'description': 'Quantitative, automated reading of hippocampal volume from MRI scans, complemented by a general measure of brain atrophy, in addition to standard neuroradiological report.', 'interventionNames': ['Device: Brain Morphometry', 'Other: Standard radiological assessment']}, {'type': 'OTHER', 'label': 'Standard radiological assessment.', 'description': 'Standard neuroradiological report of the structural MRI only.', 'interventionNames': ['Other: Standard radiological assessment']}], 'interventions': [{'name': 'Brain Morphometry', 'type': 'DEVICE', 'description': 'Quantitative, automated reading of hippocampal volume from MRI scans, complemented by a general measure of brain atrophy, in addition to standard neuroradiological report.', 'armGroupLabels': ['Brain Morphometry']}, {'name': 'Standard radiological assessment', 'type': 'OTHER', 'description': 'Standard neuroradiological report produced by qualitative examination of structural MRI scan by trained neuroradiologist.', 'armGroupLabels': ['Brain Morphometry', 'Standard radiological assessment.']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 8AF', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Natalie N Gottlieb, BSc', 'role': 'CONTACT', 'email': 'natalie.n.gottlieb@kcl.ac.uk', 'phone': '+4420V79193084'}, {'name': 'Sergi Costafreda-Gonzalez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Natalie N Gottlieb, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andy Simmons, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Old Age Psychiatry and Dementia Clinical Academic Group, South London and Maudsley NHS Foundation Trust and King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Sergi G Costafreda-Gonzalez, MD, PhD', 'role': 'CONTACT', 'email': 'sergi.1.costafreda@kcl.ac.uk', 'phone': '+442078485862'}, {'name': 'Natalie N Gottlieb, BSc', 'role': 'CONTACT', 'email': 'natalie.n.gottlieb@kcl.ac.uk', 'phone': '+442079193084'}], 'overallOfficials': [{'name': 'Sergi Costafreda-Gonzalez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}, {'name': 'Andrew Simmons, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}, {'name': 'University of Sussex', 'class': 'OTHER'}, {'name': 'IXICO Limited', 'class': 'UNKNOWN'}, {'name': 'Cambridge Cognition Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}