Biomarkers and rapid imaging in dementia diagnosis
| ISRCTN | ISRCTN12777415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12777415 |
| IRAS number | 291170 |
| Secondary identifying numbers | CPMS 51048, IRAS 291170 |
- Submission date
- 30/10/2023
- Registration date
- 21/02/2024
- Last edited
- 19/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
MRI is an essential part of the diagnostic workup in dementia, however, the time taken and cost limit its availability. Reduction in scan time will solve these issues. This study aims to develop an ultra-fast MRI scan cutting the gold-standard MRI scan from 30 to 7 minutes, with these scans providing non-inferior images to aid in dementia diagnosis.
Who can participate?
Patients referred to the National Hospital for Neurology and Neurosurgery
What does the study involve?
The study involves a standard clinical MRI scan (30 minutes) with an additional 7 minutes for the ultra-fast scan, donation of a blood sample and 10 minutes of neuropsychology
What are the possible benefits and risks of participating?
There is no direct benefit for participating in the study. Some people experience minor discomfort, bruising or swelling following a blood draw. There is also a small risk of developing an infection at the site of blood draw. MRI scans may feel slightly uncomfortable due to the noise the machine makes. The table you lie on may feel hard, and the room may be cool, but the medical team will do everything they can to make you comfortable and blankets may be provided. You may be tired or sore from lying
in one position for a long time. Some people experience claustrophobia when having a scan, but the medical team will do whatever they can to help you relax before and during the scan. The MRI scanner produces loud tapping, knocking, chirping and squeaking sounds during the scans. Before your scan, the technicians will give you disposable foam ear plugs and headphones to wear to protect your hearing from the loud noise. Cognitive testing can be mentally tiring but is unlikely to cause any harm.
Where is the study run from?
National Hospital for Neurology and Neurosurgery (UK)
When is the study starting and how long is it expected to run for?
August 2021 to July 2025
Who is funding the study?
1. Biogen
2. Alzheimer's Society
3. Rosetrees Trust
Who is the main study contact?
1. Millie Beament, m.beament@ucl.ac.uk
2. Prof. Nick Fox, n.fox@ucl.ac.uk
Contact information
Scientific, Principal Investigator
First Floor 8-11 Queen Square
London
WC1N 3AR
United Kingdom
| Phone | +44 (0)20 3448 4773 |
|---|---|
| n.fox@ucl.ac.uk |
Public
First Floor 8-11 Queen Square
London
WC1N 3AR
United Kingdom
| Phone | +44 (0)20 3448 4773 |
|---|---|
| m.beament@ucl.ac.uk |
Study information
| Study design | Single-centre cross-sectional observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Biomarkers & accelerate magnetic resonance imaging for dementia diagnosis |
| Study acronym | B-RAPIDD |
| Study hypothesis | There is overwhelming pressure on healthcare systems to provide wider and more timely access to a dementia diagnosis. Structural MRI scans are an essential part of the diagnostic workup in dementia but their availability is confounded by their price and time taken. Making a substantial reduction in scan time would tackle these issues and mean that MRI would be available to most cases. This study develops an ultra-fast scanning protocol shortening scan time from 30 minutes to 7 minutes without impacting image quality. We will assess the ability of ultra-fast MRI to aid in dementia diagnosis and measure change over time, over short and longer intervals. |
| Ethics approval(s) | Approved 11/01/2022, London - Hampstead Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44 (0)207 104 8248, +44 (0)207 104 8284, +44 (0)207 104 8227; hampstead.rec@hra.nhs.uk), ref: 21/LO/0815 |
| Condition | Dementia |
| Intervention | 170 participants from the cognitive disorders clinic at the National Hospital for Neurology and Neurosurgery (UCLH) will be recruited. These participants are due to have a same-day MRI scan which takes 30 minutes, this study adds an additional 7 minutes in scanning time. They will also be asked to provide a blood sample and undergo a brief neuropsychological examination. Participants in the longitudinal sub-studies will have the same as above at their first visit, with repeat scanning at subsequent visits, as well as optional blood sample collections. |
| Intervention type | Other |
| Primary outcome measure | Non-inferiority of ultra-fast MRI compared to gold standard MRI assessed using a 5-point Likert scale at baseline |
| Secondary outcome measures | 1. Stability of ultra-fast MRI compared to gold standard MRI, assessed using a 5-point Likert scale at 2 weeks to 2 months 2. Ability of ultra-fast MRI to track longitudinal change compared to gold standard MRI, assessed using a 5-point Likert scale at 1 year 3. Blood biomarkers assessed by immunoassays at baseline, 2 weeks to 2-month interval and 1-year interval |
| Overall study start date | 01/08/2021 |
| Overall study end date | 01/07/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 170 |
| Participant inclusion criteria | 1. An individual with ability to engage in the decision to participate in the research study and provide informed consent 2. Aged 18 years old and above Main study: Patients attending the CDC at NHNN and at Darent Valley Hospital who are due to have a standard-of-care MRI of the brain as part of their routine investigation. Sub-study 1: Participants in other REC approved studies, who are scheduled for a planned MRI brain scan Sub-study 2: Healthy controls recruited through spouses/partners of patients, individuals who are included on the DRC Research Register and Join Dementia Research and patients attending the CDC at NHNN and at Darent Valley Hospital Sub-study 3: Participants recruited to the main study who are happy to be contacted about follow-up study procedures |
| Participant exclusion criteria | 1. Unable to tolerate a routine MRI scan plus a 7-minute fast-MRI scan 2. Unable to tolerate draw blood by venepuncture |
| Recruitment start date | 21/03/2022 |
| Recruitment end date | 01/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
WC1N 3BG
United Kingdom
Sponsor information
Hospital/treatment centre
UCLH/UCL Joint Research Office
4th Floor, West
250 Euston Road
London
NW1 2PG
England
United Kingdom
| Phone | N/A |
|---|---|
| uclh.jro-communications@nhs.net | |
| Website | http://www.london.ac.uk/ |
"ROR" |
https://ror.org/04cw6st05 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Biogen Inc.
- Location
- United States of America
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- alzheimerssoc
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Teresa Rosenbaum Golden Charitable Trust, Rosetrees
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| 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 | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
19/07/2024: The following changes were made:
1. The recruitment end date was changed from 01/07/2024 to 01/07/2025.
2. The overall study end date was changed from 01/07/2024 to 01/07/2025.
3. The intention to publish date was changed from 01/07/2025 to 01/07/2026.
30/10/2023: Trial's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
