Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT06385951
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spatial Navigation for the Early Detection of Alzheimer's Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2028-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spatial navigation abilities', 'timeFrame': '1 hour', 'description': 'Spatial navigation abilities (egocentric and allocentric) will be measured by means of the ALLO iVR task.'}], 'secondaryOutcomes': [{'measure': 'Medial Temporal Lobe atrophy', 'timeFrame': '20 minutes', 'description': 'MRI'}, {'measure': 'Amount and spreading of amyloid in the brain', 'timeFrame': '1 hour', 'description': 'Amyloid PET'}, {'measure': 'Amount and spreading of tau in the brain', 'timeFrame': '1 hour', 'description': 'Tau-PET'}, {'measure': 'Decreases in cerebral glucose metabolism in the brain', 'timeFrame': '1 hour', 'description': 'FDG-PET'}, {'measure': 'Cognitive functioning', 'timeFrame': '1.5 hours', 'description': 'Neuropsychologische examination'}, {'measure': 'amyloidB1-42 / 40 ratio, total tau and phosphorylated tau', 'timeFrame': '1 hour', 'description': 'Lumbar puncture'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Alzheimer Disease', 'Healthy Aging']}, 'descriptionModule': {'briefSummary': "Alzheimer's Disease (AD) is the most common form of dementia and may contribute to 60-70 % of all cases. An early, accurate diagnosis of AD will become increasingly important with disease-modifying therapies. Different types of fluid and neuroimaging biomarkers are available for the early detection of AD. However, implementation of routine use of these biomarkers in clinical settings is held back due to the risk of overdiagnosis, increased cost and invasiveness of the assessment method. Therefore, novel biomarkers are needed beyond the amyloid and tau pathologies for the early diagnosis of AD. Neuropsychological paper and pencil tests can detect AD and discriminate between different clinical stages. Since medial temporal lobe structures, including the hippocampus and entorhinal cortex (EC), are involved in spatial navigation and degenerate in the earliest stages of AD, spatial navigation can be considered as an early cognitive biomarker of the disease. Nonetheless, the measurement of spatial navigation needs further improvement since the current paper and pencil tests lack ecological validity. Therefore, the test environment should be set up in immersive Virtual Reality (iVR). Dr. Andrea Castegnaro (Space and Memory Lab of University College of London) developed the Allocentric Spatial Update Task (ALLO task), which is an iVR task measuring egocentric and allocentric spatial abilities.\n\nTherefore, the main objective of this study is to evaluate whether allocentric and egocentric spatial navigation, measured by the ALLO iVR task can be considered a cognitive biomarker for the early detection of AD. In addition, the investigators want to report on the neuronal correlates of both spatial navigation strategies.\n\nThrough the Department of Neurology of the University Hospital of Ghent, which has a large cognitive disorders clinic, patients with mild cognitive impairment and mild Alzheimer's dementia will be recruited. Participants will undergo standard clinical assessment, including a neuropsychological examination, Magnetic Resonance Imaging, a 18F-fluorodeoxyglucose PET and a Lumbar Puncture. In addition, participants will also be asked to undergo Tau PET imaging, Amyloid PET imaging and complete the ALLO iVR task. Healthy controls will also be recruited and have to undergo the same investigations, except for the amyloid PET and lumbar puncture.", 'detailedDescription': "Alzheimer's Disease (AD) is the most common form of dementia and may contribute to 60-70 % of all cases. It can be presented as a spectrum of progressive cognitive decline, with early episodic memory impairment, followed by progressive deterioration of other cognitive functions such as praxis, visual processing and spatial navigation. An early, accurate diagnosis of AD will become increasingly important with disease-modifying therapies. Different types of fluid and neuroimaging biomarkers are available for the early detection of AD. However, implementation of routine use of these biomarkers in clinical settings is held back due to the risk of overdiagnosis, increased cost and invasiveness of the assessment method. Therefore, novel biomarkers are needed beyond the amyloid and tau pathologies for the early diagnosis of AD.\n\nNeuropsychological paper and pencil tests can detect AD and discriminate between different clinical stages. Traditionally, early episodic memory impairment has been considered the most specific cognitive biomarker of early AD. However, since medial temporal lobe structures, including the hippocampus and entorhinal cortex (EC), are involved in spatial navigation and degenerate in the earliest stages of AD, spatial navigation can also be considered as an early cognitive biomarker of the disease. Nonetheless, the measurement of spatial navigation needs further improvement since the current paper and pencil tests lack ecological validity. Therefore, we should evolve to a more innovative way of spatial navigation assessment that is more in line with the real world and set up the test environment in immersive Virtual Reality (iVR). Dr. Andrea Castegnaro (Space and Memory Lab of University College of London) developed the Allocentric Spatial Update Task (ALLO task), which is an iVR task measuring egocentric and allocentric spatial abilities.\n\nTherefore, the main objective of this study is to evaluate whether allocentric and egocentric spatial navigation, measured by the ALLO iVR task can be considered a cognitive biomarker for the early detection of AD. In addition, the investigators want to report on the neuronal correlates of both spatial navigation strategies.\n\nThrough the Department of Neurology of the University Hospital of Ghent, which has a large cognitive disorders clinic, patients with mild cognitive impairment and mild Alzheimer's dementia will be recruited. Participants will undergo standard clinical assessment, including a neuropsychological examination, Magnetic Resonance Imaging, a 18F-fluorodeoxyglucose PET and a Lumbar Puncture. In addition, participants will also be asked to undergo Tau PET imaging, Amyloid PET imaging and complete the ALLO iVR task. Healthy controls will also be recruited and have to undergo the same investigations, except for the amyloid PET and lumbar puncture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD)\n* Patients with a mild Alzheimer's Dementia\n* Patients with MCI without a formal dementia diagnosis\n* Healthy controls\n\nExclusion Criteria:\n\n* Diabetes (only for healthy controls)\n* Epilepsy\n* Presence of extreme depressive symptoms (\\>11 on Geriatric depression scale or \\>20 on Beck depression inventory)\n* Presence of extreme anxiety (\\>22 on Beck Anxiety Inventory)\n* A major psychiatric of medical disorder\n* Alcohol excess\n* Moderate to severe white matter lesions on MRI (\\>2 Fazekas)\n* Any visual of mobility impairment of such severity as to compromise the ability to undertake the iVR task."}, 'identificationModule': {'nctId': 'NCT06385951', 'acronym': 'ALLO-task', 'briefTitle': "Spatial Navigation for the Early Detection of Alzheimer's Disease.", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': "An Immersive Virtual Reality Spatial Navigation Task as Potential Biomarker for the Early Detection of Alzheimer's Disease.", 'orgStudyIdInfo': {'id': 'ONZ-2023-0323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients', 'description': "Patients with mild cognitive impairment and mild Alzheimer's dementia", 'interventionNames': ['Diagnostic Test: Procedure for patients']}, {'type': 'OTHER', 'label': 'Healthy volunteers', 'description': 'Healthy volunteers', 'interventionNames': ['Diagnostic Test: Procedure for healthy controls']}], 'interventions': [{'name': 'Procedure for patients', 'type': 'DIAGNOSTIC_TEST', 'description': 'We will screen patients who undergo an MRI and neuropsychological examination as part of their diagnostic workup. If inclusion and exclusion criteria are met, patients will be asked to undergo additional investigations (FDG-PET, lumbar puncture, tau and amyloid PET and the ALLO iVR task).', 'armGroupLabels': ['Patients']}, {'name': 'Procedure for healthy controls', 'type': 'DIAGNOSTIC_TEST', 'description': 'Healthy controls will be asked to undergo a neuropsychological examination, the ALLO iVR task, an MRI, FDG-PET and tau-PET.', 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East-Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Tineke Van Vrekhem', 'role': 'CONTACT', 'email': 'tineke.vanvrekhem@uzgent.be', 'phone': '093326483'}], 'facility': 'University Hospital Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Tineke Van Vrekhem, Master', 'role': 'CONTACT', 'email': 'Tineke.VanVrekhem@uzgent.be', 'phone': '093326483'}], 'overallOfficials': [{'name': 'Paul Boon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Prof. Dr. Paul Boon', 'investigatorAffiliation': 'University Hospital, Ghent'}}}}