Optical Neuroimaging and Cognition

NCT05460143 | Recruiting

• 1 other identifier: 319284
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia With Lewy Bodies; Alzheimer Disease; Mild Cognitive Impairment

Keywords

Dementia

Outcome Measures

Primary Outcomes (3)

• Brain oxygenation

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

  Within the study session (1 hour)

• Brain metabolism

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

  Within the study session (1hour)

• 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.

  Within the study session (1 hour)

Secondary Outcomes (3)

• ACE-R score

  Within the study session (maximum 1 hour)

• Rey Auditory Verbal learning test

  Within the study session (maximum 1 hour)

• Geriatric depression scale

  Within the study session (maximum 1 hour)

Study Arms (5)

Dementia with Lewy Bodies

These subjects should meet the criteria for dementia with Lewy Bodies (McKeith et al. (2005). Diagnosis and management of dementia with Lewy bodies: Third report of the DLB consortium. Neurology. 65:1863-72.).

Other: Near-infrared Spectroscopy scan; Other: Magnetic Resonance Imaging scan

Alzheimer's Disease

These subjects should have a clinical diagnosis of AD in accordance with the National Institute of Neurological Disorders and Stroke-Alzheimer Disease and Related Disorders criteria (McKhann, G. M., et al. 2011. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 7:263-9.).

Other: Near-infrared Spectroscopy scan; Other: Magnetic Resonance Imaging scan

Mild Cognitive Impairment - LB

Mild Cognitive Impairment in a single or a multiple domain (Jak et al., 2009) with at least one LB symptom (MCI-LB; McKeith, I. G., et al. 2020. Research criteria for the diagnosis of prodromal dementia with Lewy bodies. Neurology. 94(17): 743-55.).

Other: Near-infrared Spectroscopy scan

Mild Cognitive Impairment - AD

Mild Cognitive Impairment in a single or a multiple domain (Jak et al., 2009) with AD symptoms (MCI-AD; Dubois, B., et al. 2009. Early detection of Alzheimer's disease: new diagnostic criteria. Dialogues Clin Neurosci. 11(2): 135-9.).

Other: Near-infrared Spectroscopy scan

Healthy controls

These subjects should have MMSE scores above 26, no regular memory complaints, no signs/symptoms of dementia and no unstable or significant medical illness.

Other: Near-infrared Spectroscopy scan

Interventions

Near-infrared Spectroscopy scan OTHER

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.

Also known as: NIRS

Alzheimer's Disease; Dementia with Lewy Bodies; Healthy controls; Mild Cognitive Impairment - AD; Mild Cognitive Impairment - LB

Magnetic Resonance Imaging scan OTHER

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

Also known as: MRI

Alzheimer's Disease; Dementia with Lewy Bodies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• A diagnosis of probable:
• 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
• A good grasp of the English language
• An informant (either a carer or family member) who will be available throughout testing (only relevant if in a patient group)

You may not qualify if:

• Severe dementia
• Unable to participate
• A MMSE score below 12
• A condition which influences metabolism or haemodynamics
• Such as metabolic or respiratory disorders
• A significant mental illness
• Such as rheumatoid arthritis, systemic lupus erythematosus
• Oral steroid use
• A significant psychiatric disorder
• MCI due to other causes such as traumatic brain injury, vascular dementia, or fronto-temporal dementia
• A history of excessive drug or alcohol use
• Contraindications to MRI (only for patient groups undertaking the MRI scan: AD/MCI/DLB)
• Surgical implants e.g. pacemakers
• Obesity

Sponsors & Collaborators

• University of Cambridge: lead
• 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

Study Sites (1)

Univeristy of Cambridge

Cambridge, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lewy Body Disease; Alzheimer Disease; Cognitive Dysfunction; Dementia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Cognition Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Gemma Bale, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilia Butters, MSc

CONTACT

07462064164; eb857@cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 15, 2022
• Study Start: May 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)