ADAPT: Alzheimer’s disease Diagnosis And Plasma P-Tau217
Research type
Research Study
Full title
ADAPT: Alzheimer’s disease Diagnosis And Plasma P-Tau217 A multi-centre diagnostic randomised controlled trial of disclosure of results of plasma p-tau217 to community memory clinic patients and clinicians in the UK
IRAS ID
332672
Contact name
Pushpsen Joshi
Contact email
Sponsor organisation
UCLH NHS Foundation Trust
ISRCTN Number
ISRCTN16203689
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Alzheimer’s disease (AD) is the commonest sub-type diagnosis for people who have mild cognitive impairment (MCI) or dementia. Confirming AD is important now because it allows patients to access the right symptomatic treatments and support, and to be screened for recruitment to AD clinical trials. In the future it will be vital if patients are to be eligible for MHRA approved disease modifying treatments if they became available on the NHS.
Confirming AD currently requires either expensive amyloid PET scans, or invasive lumbar punctures, to which most people who are diagnosed with MCI or AD in community memory clinics in the UK do not have access. However, recent research shows that AD can be detected early and accurately using blood tests, the most promising of which is plasma p-tau217.
Funded by the Alzheimer’s Research UK Blood Biomarker Challenge, ADAPT is a multi-centre randomized controlled trial of disclosure of plasma p-tau217 results to patients and memory service clinicians in up to 20 community memory clinics across the UK. The p-tau217 result will be added to a standard assessment for people referred to the memory clinic for the first time, whom the memory clinician judges may have MCI or dementia that could be due to AD. Out of 1100 people taking part, half will find out their p-tau217 results after 3 months, and the remainder after 12 months. Follow up over 15 months will find out whether the p-tau217 result makes a difference to how many people are diagnosed with AD, the treatment and care received, costs of care, quality of life and experience of the diagnostic pathway. The evidence from this study will be used to help to assess whether this blood test should be included in the standard of care in memory clinics in the NHS.
REC name
HSC REC B
REC reference
24/NI/0149
Date of REC Opinion
8 Jan 2025
REC opinion
Further Information Favourable Opinion