Optical Neuroimaging and Cognition

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Cambridge

About this trial

Dementia is associated with a variety of neurovascular and neurometabolic abnormalities. Traditional imaging techniques used to investigate such abnormalities, such as Positron Emission Tomography and functional Magnetic Resonance Imaging, are not always well tolerated, have expensive start up and running costs, and are limited with regards to the types of experiments that can be performed as they can be highly sensitive to movement, are noisy, and have physical restrictions.

Near-infrared spectroscopy (NIRS) is a non-invasive neuroimaging technique which uses light in the near-infrared spectrum to detect relative changes in concentration of oxygenated and deoxygenated haemoglobin, and the oxidation state of Cytochrome C Oxidase. As such, NIRS can provide measures of brain oxygenation and metabolism. NIRS is less sensitive to movement, is well tolerated and has few contraindications. It is thus a promising candidate for use in clinics or in peoples' homes for monitoring dementia.

In the present study, the investigators aim to use both dual-wavelength and broadband NIRS in a range of dementia subtypes, including Alzheimer's Disease and Dementia with Lewy Bodies, and severities, including Mild Cognitive Impairment, to identify how brain oxygenation and metabolism is altered in dementia and across various clinical subgroups. The investigators also aim to determine the relationship between brain oxygenation and metabolism in dementia, and use machine learning approaches to identify optical biomarkers for dementia.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Lewy Body Dementia

Alzheimer's Disease

Mild Cognitive Impairment (MCI-LB or MCI-AD) OR

Cognitively normal for their education and age, with a MMSE score above 26 AND

Disqualifiers

Severe dementia

Unable to participate

A MMSE score below 12

A condition which influences metabolism or haemodynamics

Trial population

The target study population is people with dementia. This includes those with Alzheimer's Disease, Dementia with Lewy Bodies, as well as those in the intermediate stages of the disease, such as Mild Cognitive Impairment. We will also recruit healthy controls.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Near-infrared Spectroscopy scan

    Other intervention

    Near-infrared spectroscopy is a non-invasive neuroimaging technique which uses light in the near-infrared spectrum to measure changes in brain oxygenation and metabolism.

  • Magnetic Resonance Imaging scan

    Other intervention

    Magnetic Resonance Imaging is a non-invasive neuroimaging technique which provides detailed structural images of the brain.

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: Dementia with Lewy Bodies2 interventions
Group B: Alzheimer's Disease2 interventions
Group C: Mild Cognitive Impairment - LB1 intervention
Group D: Mild Cognitive Impairment - AD1 intervention
Group E: Healthy controls1 intervention

Trial outcomes

Primary outcomes

1

Brain oxygenation

As measured with dual-wavelength NIRS. We will measure task-related relative changes in concentration in oxygenated and deoxygenated haemoglobin (µmol).

Time frame
Within the study session (1 hour)
2

Brain metabolism

As measured with broadband NIRS. We will measure task-related changes in oxidation state of Cytochrome C Oxidase(µmol).

Time frame
Within the study session (1hour)
3

Cognitive behavioural data

Behavioural scores collected through the cognitive testing performed during NIRS scans. These include scores of memory function and word retrieval, e.g., accuracy of words recalled, reaction times.

Time frame
Within the study session (1 hour)

Secondary outcomes

1

ACE-R score

Cognitive exam, out of 100%.

Time frame
Within the study session (maximum 1 hour)
2

Rey Auditory Verbal learning test

Accuracy.

Time frame
Within the study session (maximum 1 hour)
3

Geriatric depression scale

Number identified out of 15.

Time frame
Within the study session (maximum 1 hour)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cambridge

Lead sponsor

Cambridgeshire and Peterborough NHS Foundation Trust

Collaborator

The Gianna Angelopoulos Programme for Science, Technology and Innovation

Collaborator

The Newton Trust

Collaborator

Alzheimer's Research UK

Collaborator