Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385951
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-03
Brief Title:
Spatial Navigation for the Early Detection of Alzheimers Disease
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
An Immersive Virtual Reality Spatial Navigation Task as Potential Biomarker for the Early Detection of Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALLO-task
Brief Summary:
Alzheimers 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
Therefore 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
Through the Department of Neurology of the University Hospital of Ghent which has a large cognitive disorders clinic patients with mild cognitive impairment and mild Alzheimers 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
Therefore 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
Through the Department of Neurology of the University Hospital of Ghent which has a large cognitive disorders clinic patients with mild cognitive impairment and mild Alzheimers 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
Detailed Description:
Alzheimers 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
Neuropsychological 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
Therefore 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
Through the Department of Neurology of the University Hospital of Ghent which has a large cognitive disorders clinic patients with mild cognitive impairment and mild Alzheimers 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
Neuropsychological 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
Therefore 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
Through the Department of Neurology of the University Hospital of Ghent which has a large cognitive disorders clinic patients with mild cognitive impairment and mild Alzheimers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None