Trialling a blood test for Alzheimer’s disease in UK memory services
| ISRCTN | ISRCTN16203689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16203689 |
| IRAS number | 332672 |
| Secondary identifying numbers | CPMS 57904, Grant Code: ARUK-BBC2023-002 |
- Submission date
- 04/12/2024
- Registration date
- 11/02/2025
- Last edited
- 04/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
This study aims to find out whether plasma p-tau217 helps to diagnose Alzheimer’s disease more quickly at an early disease stage when added to standard UK memory clinic assessments.
Who can participate?
Individuals will be eligible to participate if they are aged 50 years or older, referred by their GP to an NHS memory service, are being seen for their first appointment, have a progressive cognitive complaint reported by themself or their study partner (family member/friend/carer) and are judged by their assessing memory service clinician to have objective impairment with a presentation of either mild cognitive impairment or dementia (mild or moderate, such that they are able to provide informed consent to participate at baseline). Individuals are asked to nominate a study partner who has at least weekly contact with them (family member/friend/carer) who will also be asked to provide informed consent to participate. Individuals who have the capacity to consent at baseline and lose capacity over the course of the study will be eligible to continue participating if they and their study pattern are willing.
What does the study involve?
The location of the study will be sites where patients would normally be referred for assessment of memory problems and would occur at the same time as their normal clinical visits. Individuals will be seen face to face three times over a year (at the start, at 3 months and at 1 year) and will have two telephone-based assessments at 6 and 15 months. As this is part of the normal NHS assessment, no additional travel costs will be incurred. Individuals will be encouraged to attend with a family member, friend or carer as they would do for a normal memory clinic appointment. After the first clinic visit, individuals and their family members/friends/carers will be invited to join the study by their clinicians. Those who consent will donate a blood sample and information about them and their health will be collected. this will add no more than 75 minutes to the standard memory clinic assessment. Individuals and their family members/friends/carers will return to see their doctor to receive a diagnosis at 3 months. At this visit the blood test result will be available to the doctor for half of the patients seen. after the clinic visit the patient and their family member/friend will be invited to be asked some questions about their experience, adding 30 minutes to the assessment. At 6 months the participant and the family member/friend/carer will be contacted by telephone and asked a series of questions, with each call taking no more than 60 minutes. At 12 months individuals and their family member/friend/carer will return for a clinic visit and the blood test result will be available to the clinician for the remaining half of the individuals seen. After the clinic visit, the individual and their family member/friend/carer will be asked some questions, taking no longer than 30 minutes. at 15 months they will have a telephone call similar to that undertaken at 6 months and lasting no more than 60 minutes.
What are the possible benefits and risks of participating?
Participation will mean that the memory service clinician responsible for making a diagnosis has access to the blood test result, which may aid the diagnosis as part of their assessment. There are known risks associated with blood sampling (local pain, bruising, infection) which are managed in accordance with standard clinical practice and local standard operating procedures. There is a risk of psychological distress related to the diagnosis being changed on the basis of the blood test either to or from Alzheimer’s disease. Change of diagnosis is also a possible outcome through clinical follow-up alone (whether or not the blood tests contribute to that change) and so the psychological distress associated with diagnosis or change of diagnosis would be managed according to the standard of care provided by the memory service, which includes referral for post-diagnostic psychological support where deemed appropriate.
Where is the study run from?
The study sponsor is the UCL Comprehensive Clinical Trials Unit (UK). The study will be delivered by the NIHR research delivery network in partnership with NHS trusts across the UK in which memory services are located.
When is the study starting and how long is it expected to run for?
April 2024 to March 2029
Who is funding the study?
1. Alzheimer’s Research UK
2. Alzheimer’s Society (UK)
3. National Institute for Health and Care Research (UK)
4. People’s Postcode Lottery (UK)
5. Gates Ventures
Who is the main contact?
Trial manager, cctu.adapt@ucl.ac.uk
Contact information
Comprehensive Clinical Trials Unit
Institute of Clinical Trials and Methodology
90 High Holborn
2nd Floor
London
WC1V 6LJ
United Kingdom
| cctu.adapt@ucl.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Diagnosis, Process of Care, Device, Management of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific 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 |
| Study acronym | ADAPT |
| Study objectives | The study hypothesis is that disclosure of the plasma p-tau217 result will increase the proportion of Alzheimer’s disease diagnosis in comparison to non-disclosure at 3 months after blood sampling. |
| Ethics approval(s) | Approved 08/01/2025, Health and Social Care Research Ethics Committee B (HSC REC B) (Meeting held by video-conference via Zoom, +44 (0)28 9536 1400, recb@hscni.net), ref: 24/NI/0149 |
| Health condition(s) or problem(s) studied | Alzheimer’s disease |
| Intervention | At the start of the study, consenting individuals will provide one blood sample to be sent to UCLH for analysis. Basic information including age, sex, and ethnic group will be collected. The medical records will be checked and information including any medical problems, medications, and test results (including memory tests and renal function) will be recorded. This will allow for accurate interpretation of the blood test. Participants’ baseline blood samples will be processed locally and plasma will be transferred to UCLH for ptau217 analysis. Results will be provided to the diagnosing clinician along with a guide for interpretation (including the influence of renal function and body mass index both of which in extreme cases may influence the ptau-217 result). For 50% of participants, the result will be available to their clinician to share with them at the 3-month visit; the remaining 50% at 12 months. The primary outcome will be the difference in the proportion of AD diagnoses between the two arms at 3 months. The total number of study visits will be 5. The baseline, 3-month and 12-month visits will be in person, and the 6-month and 15-month visits will be by telephone. Differences between the two arms in management (including prescription of medication), quality of life and economic impacts will be captured (face-to-face at 3 and 12 months; by telephone assessments at 6 and 15 months) and analysed by economists at the LSE. A small number of individuals taking part will be offered the opportunity to be interviewed (either as individuals or in groups) about their experiences and views of the study. This will be recorded and transcribed but kept anonymous. |
| Intervention type | Other |
| Primary outcome measure | Alzheimer’s disease diagnosis, measured as clinician assignment of diagnosis at 3 and 12 months |
| Secondary outcome measures | 1. Clinician confidence in diagnosis of Alzheimer’s disease, measured on a Likert scale before and after consultation at 3 months and at 12 months 2. Change of diagnoses to or from Alzheimer’s disease, measured by change in clinician assignment of diagnosis at 3 and 12 months 3. Clinician activities indicating Alzheimer’s disease diagnosis: initiation of AD drug therapy, provision of AD post-diagnostic counselling, clinical trial referral, ascertained by collection of these data by case record forms from study clinicians and corroborated by local medication prescription records, at 3, 6, 12 and 15 months 4. Health-related quality of life, measured using the EQ5D-5L questionnaire at baseline, 3, 6, 12 and 15 months 5. Mean costs indexed by NHS and social care resource use and costs, measured using the Client Service receipt Inventory at baseline, 3, 6, 12 and 15 months |
| Overall study start date | 01/04/2024 |
| Completion date | 31/03/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1100; UK Sample Size: 1100 |
| Key inclusion criteria | 1. Age >=50 years 2. Referred to NHS memory service, being seen for first appointment 3. Presence of a cognitive complaint by the patient (and/or study partner) 4. History of progressive decline in the opinion of the investigator 5. Objective evidence for impairment as evidenced by any of MMSE <28, MOCA <28, ACE-III <90, RUDAS <28 in an appropriate language 6. Alzheimer’s disease is a diagnostic consideration, with a presentation of either Mild Cognitive Impairment (MCI) or mild or moderate dementia 7. Able to nominate a study partner who has regular contact (at least weekly) 8. Willing and able to provide consent (including via a proxy) |
| Key exclusion criteria | 1. Normal cognition or subjective complaints that are not supported by cognitive testing 2. Amyloid status and/or plasma p-tau217 status already known to patient or referring clinician based on prior amyloid PET, CSF analysis or plasma biomarker 3. Lacks capacity to provide consent at recruitment visit |
| Date of first enrolment | 01/06/2025 |
| Date of final enrolment | 31/03/2027 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Westcliff-on-sea
SS0 0RY
United Kingdom
Wilsons Lane
Coventry
CV6 6NY
United Kingdom
Bridge Park Plaza
Bridge Park Road
Leicester
LE4 8PQ
United Kingdom
Calmore
Southampton
SO40 2RZ
United Kingdom
4 St Pancras Way
London
NW1 0PE
United Kingdom
Hermitage Lane
Maidstone
ME16 9PH
United Kingdom
1010 Pioneer Avenue
Gloucester Business Park
Gloucester
GL3 4AW
United Kingdom
Kingsway Hospital
Kingsway
Derby
DE22 3LZ
United Kingdom
Southall
UB2 4SD
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Dundee
DD1 9SY
United Kingdom
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
2-4 Waterloo PLACE
Edinburgh
City of Edinburgh
EH1 3EG
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| jro.sponsorship@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Alzheimer's Research Trust, AlzheimersResearch UK, AlzResearchUK, ARUK
- Location
- United Kingdom
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/03/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results of the trial will be disseminated regardless of the direction of effect. Publication will comply with the UCL CCTU publication policies. A lay summary of the results will also be provided to be disseminated to those participants who took part who express an interest in the findings. A summary of results and end-of-trial report will be submitted to the Research Ethics Committee via the HRA and the MHRA, and published through an open-access mechanism in a high-impact peer-reviewed journal within 12 months of trial closure. Within one year of the end of the trial a public-facing plain language written summary, a short documentary and podcasts will be co-produced with the PPI group. These will summarise the findings and their potential impact. This information will be disseminated across health and social care organisations, charities, community groups, open days, festivals and other fora. This work will be conducted according to University of Kent policy and protocol regarding social media and the co-development/sharing of media content with patients and the public. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
04/04/2025: The recruitment start date was changed from 01/04/2025 to 01/06/2025.
04/12/2024: Study's existence confirmed by the NIHR.
