Spatial Navigation for the Early Detection of Alzheimer's Disease.

NCT06385951 | Recruiting

• 1 other identifier: ONZ-2023-0323
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Healthy Aging

Outcome Measures

Primary Outcomes (1)

• Spatial navigation abilities

  Spatial navigation abilities (egocentric and allocentric) will be measured by means of the ALLO iVR task.

  1 hour

Secondary Outcomes (6)

• Medial Temporal Lobe atrophy

  20 minutes

• Amount and spreading of amyloid in the brain

  1 hour

• Amount and spreading of tau in the brain

  1 hour

• Decreases in cerebral glucose metabolism in the brain

  1 hour

• Cognitive functioning

  1.5 hours

Study Arms (2)

Patients

OTHER

Patients with mild cognitive impairment and mild Alzheimer's dementia

Diagnostic Test: Procedure for patients

Healthy volunteers

OTHER

Healthy volunteers

Diagnostic Test: Procedure for healthy controls

Interventions

Procedure for patients DIAGNOSTIC_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).

Patients

Procedure for healthy controls DIAGNOSTIC_TEST

Healthy controls will be asked to undergo a neuropsychological examination, the ALLO iVR task, an MRI, FDG-PET and tau-PET.

Healthy volunteers

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Gent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Paul Boon, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tineke Van Vrekhem, Master

CONTACT

093326483; Tineke.VanVrekhem@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 26, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

BE (1)