NCT05460143Recruiting
Optical Neuroimaging and Cognition
Wearable Optical Monitoring of Brain Function in Healthy Adults and People With Dementia
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 6 Jul 2022
- Start date
- 1 May 2023
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- University of Cambridge
- Diseases
- Lewy body dementia, Alzheimer disease
- NCT number
- NCT05460143
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 May 2023 to the primary completion date, 1 Sept 2025
- 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.
Prior treatment
- Contraindications to MRI (only for patient groups undertaking the MRI scan: AD/MCI/DLB)
- Surgical implants e.g. pacemakers
- Obesity
Other illness
- 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
Who 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
- 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)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Univeristy of Cambridge Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.