Salivary biomarkers, dementia and delirium: feasibility & pilot study
Research type
Research Study
Full title
A feasibility and pilot study comparing levels of salivary Aβ42, p-Tau181, p-Tau217 and neuron-derived exosomal Aβ42 between older adults with and without dementia and delirium
IRAS ID
306534
Contact name
W David Strain
Contact email
Sponsor organisation
Royal Devon University Healthcare NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Alzheimer’s dementia (AD) results in progressive memory loss, behavioural changes and dependence on others, often with devastating effects for patients and their friends and families. Harmful amyloid and tau proteins build up in the brains of people with AD many years before they show symptoms of dementia. Finding these proteins earlier may enable us to identify and treat these people before the onset of dementia, potentially preserving brain function for longer.
At present, the best way to measure amyloid and tau proteins is via detailed brain scans or lumbar punctures, where fluid is taken from the spinal cord. However, these are invasive and difficult to perform on all people with suspected dementia.
Early trials have shown that certain amyloid proteins (Aβ42) associated with Alzheimer’s disease can be found in saliva. Other amyloid (NDE Aβ42) and tau (p-Tau181 & p-Tau217) proteins linked with Alzheimer's dementia have been found in blood, but currently we do not know if these are also present in saliva. Identifying salivary proteins that predict someone's risk of future AD would offer a cheaper, less-invasive and far more convenient way of testing for the disease.
In this feasibility and pilot study, we intend to measure the four proteins above in saliva in 100 people admitted to hospital. These will includes patients with AD, delirium (acute confusion), Parkinson’s disease with cognitive impairment and dementia with Lewy bodies, along with those displaying no signs of dementia or delirium (a healthy control population).
We will assess whether the laboratory methods for measuring these salivary proteins are effective and whether the sample size required for a larger study would be possible to achieve. We will also attempt to measure these proteins in blood, to determine whether a larger trial comparing AD proteins in saliva and blood would be feasible.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0004
Date of REC Opinion
3 Mar 2023
REC opinion
Further Information Favourable Opinion