BriDGe
Research type
Research Study
Full title
BriDGe: Bringing Alzheimer's Disease biomarkers to General practice
IRAS ID
360471
Contact name
Craig Ritchie
Contact email
Sponsor organisation
Scottish Brain Sciences
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Currently more than 55 million have dementia worldwide, with numbers predicted to double every twenty years to reach 78 million in 2030 and 139 million in 2050. Alzheimer’s disease (AD) is the leading cause of dementia globally affecting ~7M people in Europe. Early detection of the AD-associated pathologies that build-up in the brain can help diagnose people early and provide therapies before people experience cognitive decline. Roche Diagnostics have developed new blood-based biomarkers that can help identify these early pathological changes in a non-invasive way. Specifically, the Roche Diagnostics pTau181 and pTau217 protein tests have demonstrated very high predictive value for one of these brain pathologies, amyloid-β, and are now being prepared for market readiness to rule out underlying Alzheimer’s disease pathology, with a dual cut-off available for pTau217 used to be able to both rule-in and rule-out underlying Alzheimer's disease. Initially, these tests are likely to be used in specialist secondary care settings, however the long-term transformative potential of these tests lies within primary care where they can be used to help primary care physicians to manage patients with cognitive impairment (subjective or objective) onward referral and/or further assessment and management in primary care for non-Alzheimer’s causes of cognitive changes. There is currently an evidence gap around how these tests should best be integrated into primary care models in the UK, in both NHS and private healthcare settings. The aim of this current study is to understand how these blood-based biomarkers impact GP confidence in managing patients with cognitive impairment, and confidence in ordering and interpreting these tests. Additionally, the study will explore clinician and patient experiences of this process with the aim of informing educational materials for primary care practitioners. Finally, the health economics of these blood-based biomarkers will be evaluated.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0197
Date of REC Opinion
1 Oct 2025
REC opinion
Further Information Favourable Opinion