Mild Cognitive ImpairmentALLO-taskNCT06385951
Spatial Navigation for the Early Detection of Alzheimer's Disease.
A study testing Procedure for patients in people with Mild Cognitive Impairment and Alzheimer Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Healthy Aging
- What is being tested?
- Procedure for patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Mar 2024to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD)
- Patients with a mild Alzheimer's Dementia
- Patients with MCI without a formal dementia diagnosis
- Healthy controls
Who cannot join
- Diabetes (only for healthy controls)
- Epilepsy
- Presence of extreme depressive symptoms (>11 on Geriatric depression scale or >20 on Beck depression inventory)
- Presence of extreme anxiety (>22 on Beck Anxiety Inventory)
- A major psychiatric of medical disorder
- Alcohol excess
- Moderate to severe white matter lesions on MRI (>2 Fazekas)
- Any visual of mobility impairment of such severity as to compromise the ability to undertake the iVR task.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Gent
Ghent, East-Flanders, 9000
Tineke Van Vrekhem, 093326483, tineke.vanvrekhem@uzgent.be
About this study
Official title: An Immersive Virtual Reality Spatial Navigation Task as Potential Biomarker for the Early Detection of Alzheimer's Disease.
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.
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 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.
Read the detailed description
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.
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 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Healthy Aging
- Being tested
- Procedure for patients, Procedure for healthy controls
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure for patientsDiagnostic test
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).
Procedure for healthy controlsDiagnostic test
Healthy controls will be asked to undergo a neuropsychological examination, the ALLO iVR task, an MRI, FDG-PET and tau-PET.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Patients with mild cognitive impairment and mild Alzheimer's dementia Receives: Diagnostic Test: Procedure for patients |
| Healthy volunteers | Other | Healthy volunteers Receives: Diagnostic Test: Procedure for healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial navigation abilities
Spatial navigation abilities (egocentric and allocentric) will be measured by means of the ALLO iVR task.
Measured: 1 hour
Secondary outcomes (6)
Medial Temporal Lobe atrophy
MRI
Measured: 20 minutes
Amount and spreading of amyloid in the brain
Amyloid PET
Measured: 1 hour
Amount and spreading of tau in the brain
Tau-PET
Measured: 1 hour
Decreases in cerebral glucose metabolism in the brain
FDG-PET
Measured: 1 hour
Cognitive functioning
Neuropsychologische examination
Measured: 1.5 hours
amyloidB1-42 / 40 ratio, total tau and phosphorylated tau
Lumbar puncture
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start5 Mar 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Paul Boon, University Hospital, Ghent
- Investigators
- Paul Boon, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385951
- Sponsor's protocol ID
- ONZ-2023-0323
- Acronym
- ALLO-task
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Immersive Virtual Reality Spatial Navigation Task as Potential Biomarker for the Early Detection of Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT06385951
- Acronym / sponsor ID
- ALLO-task / ONZ-2023-0323
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Detailed description
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.
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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Diagnostic Test: Procedure for patientsPatients with mild cognitive impairment and mild Alzheimer's dementia |
| Healthy volunteers | Other | Diagnostic Test: Procedure for healthy controlsHealthy volunteers |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD)
- Patients with a mild Alzheimer's Dementia
- Patients with MCI without a formal dementia diagnosis
- Healthy controls
Key exclusion criteria (8 listed)
- Diabetes (only for healthy controls)
- Epilepsy
- Presence of extreme depressive symptoms (>11 on Geriatric depression scale or >20 on Beck depression inventory)
- Presence of extreme anxiety (>22 on Beck Anxiety Inventory)
- A major psychiatric of medical disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure for patientsWe 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). | Diagnostic test | Patients |
| Procedure for healthy controlsHealthy controls will be asked to undergo a neuropsychological examination, the ALLO iVR task, an MRI, FDG-PET and tau-PET. | Diagnostic test | Healthy volunteers |
Primary outcome
Spatial navigation abilities
Time frame: 1 hour
Spatial navigation abilities (egocentric and allocentric) will be measured by means of the ALLO iVR task.
6 secondary outcomes
Medial Temporal Lobe atrophy
Time frame: 20 minutes
Amount and spreading of amyloid in the brain
Time frame: 1 hour
Amount and spreading of tau in the brain
Time frame: 1 hour
Decreases in cerebral glucose metabolism in the brain
Time frame: 1 hour
Cognitive functioning
Time frame: 1.5 hours
amyloidB1-42 / 40 ratio, total tau and phosphorylated tau
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Boon, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure for patients in people with Mild Cognitive Impairment and Alzheimer Disease, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tineke Van Vrekhem, Master (093326483, Tineke.VanVrekhem@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial navigation abilities (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.