Dementia With Lewy BodiesONACNCT05460143
Optical Neuroimaging and Cognition
An observational study of Dementia With Lewy Bodies and Alzheimer Disease, run by University of Cambridge at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia With Lewy Bodies, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Near-infrared Spectroscopy scan and Magnetic Resonance Imaging scan
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2023to 1 Sep 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Univeristy of Cambridge
Cambridge
Emilia Butters, eb857@cam.ac.uk
About this study
Official title: Wearable Optical Monitoring of Brain Function in Healthy Adults and People With Dementia
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.
Read the detailed description
There are several different types of dementia including Alzheimer's Disease (AD) and Dementia with Lewy Bodies (DLB). Due to the overlapping symptomatology across types of dementia and the lack of objective biomarkers currently available for dementia, misdiagnosis rates are high. Additionally, the transition from what is commonly thought to be an intermediate stage, termed Mild Cognitive Impairment (MCI), to dementia, is not well defined. Neurovascular and metabolic dysfunction has been strongly linked to neurodegeneration and dementia, however, a mechanistic understanding of this link has not been fully developed.
Near-Infrared Spectroscopy (NIRS) is a non-invasive, non-ionising and portable neuroimaging technique which uses light to quantify changes in concentration of oxygenated and deoxygenated haemoglobin in the brain. As such, it is a highly attractive alternative to functional Magnetic Resonance Imaging as it allows access to a larger variety of individuals, can be used at the bedside or in patients' own homes, and is significantly less intrusive.
To identify how the brain's haemodynamics and metabolism is altered in dementia, this study will use NIRS in 25 patients with AD, 25 patients with DLB, 50 patients with MCI and 100 age-matched healthy controls. This study will be conducted by the School of Technology and the School of Clinical Medicine at the University of Cambridge.
Firstly, the investigators will perform several cognitive tests in these patient groups whilst measuring brain activity using a state-of-the-art, dual-wavelength, high-density NIRS device to map how the brain's haemodynamics are altered in dementia. Secondly, the investigators will perform further cognitive tests using broadband NIRS to measure how neurometabolism is altered across the patient groups. The investigators will also relate the optical data to several facets of cognition that these cognitive tests will measure including memory, attention, and motor function. Several questionnaires will also be administered to assess non-cognitive symptoms such as depression and sleep disturbances. If participants in the patient groups have not had a Magnetic Resonance Imaging (MRI) scan, or did one over two years ago, they will also undertake an MRI scan to enable the localisation of brain activity, measured by NIRS, accounting for individual differences in brain structure and atrophy patterns.
The investigators shall compare all patient groups (AD, DLB, MCI) with healthy controls to determine how the brain's haemodynamics and metabolism are altered in dementia, as well as how this relates to both behavioural scores (collected during cognitive testing) and clinical scores (using either data collected from questionnaires or patient's own clinical history). Through combining the two NIRS techniques, the investigators shall also determine the nature of the relationship between the blood oxygenation in the surrounding vasculature and the intra-neuronal metabolic activity, and how this relationship may be altered in dementia and across different types of dementia. Additionally, the investigators shall apply computational methods, such as machine learning, to identify haemodynamic and/or metabolic signatures for use as biomarkers in the clinic.
- Being tested
- Near-infrared Spectroscopy scan, Magnetic Resonance Imaging scan
- Keywords
- Dementia
- Medical subject headings
- Lewy Body Disease, Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared Spectroscopy scanOther
Also called NIRS
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 scanOther
Also called MRI
Magnetic Resonance Imaging is a non-invasive neuroimaging technique which provides detailed structural images of the brain.
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: 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.). Receives: 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.). Receives: 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.). Receives: 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. Receives: Other: Near-infrared Spectroscopy scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain oxygenation
As measured with dual-wavelength NIRS. We will measure task-related relative changes in concentration in oxygenated and deoxygenated haemoglobin (µmol).
Measured: 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).
Measured: 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.
Measured: Within the study session (1 hour)
Secondary outcomes (3)
ACE-R score
Cognitive exam, out of 100%.
Measured: Within the study session (maximum 1 hour)
Rey Auditory Verbal learning test
Accuracy.
Measured: Within the study session (maximum 1 hour)
Geriatric depression scale
Number identified out of 15.
Measured: Within the study session (maximum 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 May 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridgeshire and Peterborough NHS Foundation Trust, The Gianna Angelopoulos Programme for Science, Technology and Innovation, The Newton Trust, Alzheimer's Research UK
- Responsible party
- Principal investigator, Gemma Bale, University of Cambridge
- Investigators
- Gemma Bale, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460143
- Sponsor's protocol ID
- 319284
- Acronym
- ONAC
- Status last verified
- Apr 2025
- First submitted
- 6 Jul 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Optical Monitoring of Brain Function in Healthy Adults and People With Dementia
- ClinicalTrials.gov ID
- NCT05460143
- Acronym / sponsor ID
- ONAC / 319284
- Keywords
- Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridgeshire and Peterborough NHS Foundation Trust, The Gianna Angelopoulos Programme for Science, Technology and Innovation, The Newton Trust, Alzheimer's Research UK
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 15 Jul 2022 (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.
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.
Detailed description
There are several different types of dementia including Alzheimer's Disease (AD) and Dementia with Lewy Bodies (DLB). Due to the overlapping symptomatology across types of dementia and the lack of objective biomarkers currently available for dementia, misdiagnosis rates are high. Additionally, the transition from what is commonly thought to be an intermediate stage, termed Mild Cognitive Impairment (MCI), to dementia, is not well defined. Neurovascular and metabolic dysfunction has been strongly linked to neurodegeneration and dementia, however, a mechanistic understanding of this link has not been fully developed.
Near-Infrared Spectroscopy (NIRS) is a non-invasive, non-ionising and portable neuroimaging technique which uses light to quantify changes in concentration of oxygenated and deoxygenated haemoglobin in the brain. As such, it is a highly attractive alternative to functional Magnetic Resonance Imaging as it allows access to a larger variety of individuals, can be used at the bedside or in patients' own homes, and is significantly less intrusive.
To identify how the brain's haemodynamics and metabolism is altered in dementia, this study will use NIRS in 25 patients with AD, 25 patients with DLB, 50 patients with MCI and 100 age-matched healthy controls. This study will be conducted by the School of Technology and the School of Clinical Medicine at the University of Cambridge.
Firstly, the investigators will perform several cognitive tests in these patient groups whilst measuring brain activity using a state-of-the-art, dual-wavelength, high-density NIRS device to map how the brain's haemodynamics are altered in dementia. Secondly, the investigators will perform further cognitive tests using broadband NIRS to measure how neurometabolism is altered across the patient groups. The investigators will also relate the optical data to several facets of cognition that these cognitive tests will measure including memory, attention, and motor function. Several questionnaires will also be administered to assess non-cognitive symptoms such as depression and sleep disturbances. If participants in the patient groups have not had a Magnetic Resonance Imaging (MRI) scan, or did one over two years ago, they will also undertake an MRI scan to enable the localisation of brain activity, measured by NIRS, accounting for individual differences in brain structure and atrophy patterns.
The investigators shall compare all patient groups (AD, DLB, MCI) with healthy controls to determine how the brain's haemodynamics and metabolism are altered in dementia, as well as how this relates to both behavioural scores (collected during cognitive testing) and clinical scores (using either data collected from questionnaires or patient's own clinical history). Through combining the two NIRS techniques, the investigators shall also determine the nature of the relationship between the blood oxygenation in the surrounding vasculature and the intra-neuronal metabolic activity, and how this relationship may be altered in dementia and across different types of dementia. Additionally, the investigators shall apply computational methods, such as machine learning, to identify haemodynamic and/or metabolic signatures for use as biomarkers in the clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dementia with Lewy Bodies | – | Other: Near-infrared Spectroscopy scan, Other: Magnetic Resonance Imaging scanThese 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.). |
| Alzheimer's Disease | – | Other: Near-infrared Spectroscopy scan, Other: Magnetic Resonance Imaging scanThese 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.). |
| Mild Cognitive Impairment - LB | – | Other: Near-infrared Spectroscopy scanMild 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.). |
| Mild Cognitive Impairment - AD | – | Other: Near-infrared Spectroscopy scanMild 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.). |
| Healthy controls | – | Other: Near-infrared Spectroscopy scanThese subjects should have MMSE scores above 26, no regular memory complaints, no signs/symptoms of dementia and no unstable or significant medical illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- A diagnosis of probable:
- Cognitively normal for their education and age, with a MMSE score above 26 AND
Key exclusion criteria (14 listed)
- Severe dementia
- A condition which influences metabolism or haemodynamics
- A significant mental illness
- A significant psychiatric disorder
- MCI due to other causes such as traumatic brain injury, vascular dementia, or fronto-temporal dementia
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 |
|---|---|---|
| Near-infrared Spectroscopy scanAlso: NIRSNear-infrared spectroscopy is a non-invasive neuroimaging technique which uses light in the near-infrared spectrum to measure changes in brain oxygenation and metabolism. | Other | Alzheimer's Disease, Dementia with Lewy Bodies, Healthy controls, Mild Cognitive Impairment - AD, Mild Cognitive Impairment - LB |
| Magnetic Resonance Imaging scanAlso: MRIMagnetic Resonance Imaging is a non-invasive neuroimaging technique which provides detailed structural images of the brain. | Other | Alzheimer's Disease, Dementia with Lewy Bodies |
Primary outcome
Brain oxygenation
Time frame: Within the study session (1 hour)
As measured with dual-wavelength NIRS. We will measure task-related relative changes in concentration in oxygenated and deoxygenated haemoglobin (µmol).
Brain metabolism
Time frame: Within the study session (1hour)
As measured with broadband NIRS. We will measure task-related changes in oxidation state of Cytochrome C Oxidase(µmol).
Cognitive behavioural data
Time frame: Within the study session (1 hour)
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.
3 secondary outcomes
ACE-R score
Time frame: Within the study session (maximum 1 hour)
Rey Auditory Verbal learning test
Time frame: Within the study session (maximum 1 hour)
Geriatric depression scale
Time frame: Within the study session (maximum 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 10 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Gemma Bale, PhD principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia With Lewy Bodies and Alzheimer Disease, run by University of Cambridge at 1 site in United Kingdom.
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 7 inclusion and 14 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 10 Apr 2025. 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 United Kingdom. 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 Emilia Butters, MSc (07462064164, eb857@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain oxygenation (time frame: Within the study session (1 hour)). The study lists 3 primary outcomes in all. 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 10 Apr 2025.