At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Near-infrared Spectroscopy scan (other), Magnetic Resonance Imaging scan (other)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- 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. · Magnetic Resonance Imaging scan — other: Magnetic Resonance Imaging is a non-invasive neuroimaging technique which provides detailed structural images of the brain.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2023-05-01
- Last checked
- 2025-04
Plain English Summary
What is this study?
- • Testing a new treatment for dementia with lewy bodies
- • Clinical study - 200 participants
- • Dementia is associated with a variety of neurovascular and neurometabolic abnormalities
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with dementia with lewy bodies
Where?
- • Cambridge - Univeristy of Cambridge
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗Severe dementia
- ✗Unable to participate
- ✗A MMSE score below 12
- ✗A condition which influences metabolism or haemodynamics
- ✗Such as metabolic or respiratory disorders
See the full criteria
Where Is This Study? (1 UK site)
Univeristy of Cambridge
Cambridge, United Kingdom
How to Get in Touch
Emilia Butters, MSc
Sponsor contactCONTACT
