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NCT06385951Recruiting

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

An Immersive Virtual Reality Spatial Navigation Task as Potential Biomarker for the Early Detection of Alzheimer's Disease.

Source: ClinicalTrials.gov · Last updated 26 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
160 (estimated)
First submitted
3 Apr 2024
Start date
5 Mar 2024
Primary completion date
1 Mar 2028
Lead sponsor
University Hospital, Ghent
NCT number
NCT06385951

What you commit to

  • Study type: Interventional
  • Planned participants: 160
  • From 5 Mar 2024 to the primary completion date, 1 Mar 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Diabetes (only for healthy controls)
  • Epilepsy
  • A major psychiatric of medical disorder
  • Any visual of mobility impairment of such severity as to compromise the ability to undertake the iVR task.

Other

  • 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)
  • Alcohol excess
  • Moderate to severe white matter lesions on MRI (\>2 Fazekas)

Who the study is looking for

  • 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

Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Gent
Coordinator of this site? Confirm its status
GhentBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.