Clinical performance study of the in vitro diagnostic device Elecsys® Amyloid Plasma Panel
| ISRCTN | ISRCTN63463784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63463784 |
| IRAS number | 326591 |
| Secondary identifying numbers | RD006263, CPMS 57697 |
- Submission date
- 07/08/2024
- Registration date
- 07/10/2024
- Last edited
- 06/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
This global study aims to see how well a new blood test, the Elecsys® Amyloid Plasma Panel (EAPP), can identify how likely people with memory problems are to develop Alzheimer’s disease (AD). To do so, the test identifies toxic proteins, such as amyloid, which build up in the brains of people with AD and are key characteristics in identifying people who have or are at risk of AD.
AD is an illness in the brain that causes memory problems, as well as difficulties with thinking and reasoning. It can also affect behaviour and the ability to carry out normal activities. AD is a potentially serious medical condition and not part of normal ageing. The EAPP may allow faster access to medical, personal, and emotional support, and opportunities to take part in research for people with memory problems.
Who can participate?
Males and females between the ages of 55 and 80 years who are experiencing issues with their memory, thinking and reasoning, and have not previously had a diagnosis of dementia
What does the study involve?
Participants will need to visit their study centre up to four times over a period of 3 months for procedures such as assessments of their memory and thinking, a clinical assessment, blood collection, brain imaging by PET and MRI scans, and a lumbar puncture.
What are the possible benefits and risks of participating?
The results from this study will be used to receive regulatory approval of the EAPP for use with patients with memory problems in clinics around the world. Since there is no intervention (drug) given in this study, the risks are low for the participants. Study participants may have accelerated access to Alzheimer's diagnostics than they would get in routine care.
Where is the study run from?
Roche Diagnostics (Switzerland)
When is the study starting and how long is it expected to run for?
January 2022 to October 2024
Who is funding the study?
Roche Diagnostics (Switzerland)
Who is the main contact?
David Caley, david.caley@contractors.roche.com
Contact information
Public, Scientific, Principal Investigator
Forrenstrasse 2
Rotkreuz
6343
Switzerland
| Phone | +44 (0)7731325977 |
|---|---|
| david.caley@contractors.roche.com |
Study information
| Study design | Observational multi-centre cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, Laboratory, Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A multicenter, prospective, non-interventional study to determine the cutoff and clinical performance of the Elecsys® Amyloid Plasma Panel and its component assays |
| Study acronym | EAPP |
| Study objectives | Firstly to derive the stepwise decision function for the Elecsys® Amyloid Plasma Panel (EAPP), and to calculate a cut-off for the Elecsys® Phospho-Tau (181P) plasma (pTau181p) immunoassay, which maximizes the clinical performance of each in the intended use population. Then, to demonstrate the Clinical Performance of both EAPP and pTau181p in terms of their ability to rule out subjects in the intended use population, who are most likely to be amyloid negative, by showing a high negative predictive value (NPV) and acceptable positive predictive value (PPV). |
| Ethics approval(s) |
1. Approved 18/07/2023, London - Stanmore Research Ethics Committee (2nd Floor, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048068; stanmore.rec@hra.nhs.uk), ref: 23/LO/0483 2. Approved 12/12/2023, Ethikkommission Bei Der Lmu München (Pettenkoferstr. 8a, Munich, 80336, Germany; +49 (0)89 440055191; Ethikkommission@med.uni-muenchen.de), ref: 23-0869 fed 3. Approved 31/08/2023, Ethikkommission der Medizinischen Universität Wien (Borschkegasse 8b/6, Vienna, 1090, Austria; +43 (0)1 404 00-21470, 22440; ethik-kom@meduniwien.ac.at), ref: 1267/2023 4. Approved 24/04/2023, Medical Research Ethics Committees (Ørestads Boulevard 5, Bygning 37K, st., Copenhagen, 2300, Denmark; +45 (0)72 21 66 77; kontakt@dvmk.dk), ref: 2303725 5. Approved 05/04/2023, Comité de Ética de la Investigación con medicamentos del Parc de Salut MAR (Dr. Aiguader, 88, Barcelona, 08003, Spain; +34 (0)93 316 06 77; ceic-psmar@imim.es), ref: 2023/10799 6. Approved 04/04/2023, WCG IRB (1019 39th Ave SE/ Suite 120, Puyallup, 98374, United States of America; +1 (0)855 818 2289; clientcare@wcgclinical.com), ref: 2023/10799 7. Approved 22/02/2024, Bellberry IRB (123 Glen Osmond Road, Eastwood, 5063, Australia; +61 (0)8 8361 3222; bellberry@bellberry.com.au), ref: 2023-10-1246 |
| Health condition(s) or problem(s) studied | Alzheimer's disease, amyloid pathology |
| Intervention | The duration of participation of each patient is approximately four visits over 3 months. Two study arms; cutoff establishment and pivotal clinical trial. Please note that both arms have the same methodology - only the objectives and therefore the statistical analyses differ between the two arms. There is no randomisation, sites are assigned to either one of the two arms, so patients are enrolled into the arm that their site is assigned. All potential participants will be screened - involving informed consent, an assessment against the inclusion and exclusion criteria (including administration of QDRS and MMSE) and collection of demographic information. Subjects who are screened in will have the following procedures over approximately three further visits: clinical interview, administration of Clinical Dementia Rating scale, vitals collection, blood collection (for measurement with EAPP and creatinine, and APOE genotyping, if applicable), CSF collection (for measurement with Elecesys AB42 and pTau181 biomarkers) and/or amyloid PET and MRI (T1w, T2, FLAIR). |
| Intervention type | Other |
| Primary outcome measure | Clinical performance of EAPP and pTau181p in reference to amyloid pathology status as defined by amyloid PET imaging VR. All measures are conducted at a single timepoint. |
| Secondary outcome measures | 1. Clinical performance of EAPP and pTau181p in reference to amyloid pathology status as defined by CSF biomarker analysis. All measures are conducted at a single timepoint. 2. Clinical performance of ApoE4p sub-result in reference to amyloid pathology status as defined by APOE4 genetic carrier status. All measures are conducted at a single timepoint. |
| Overall study start date | 01/01/2022 |
| Completion date | 31/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 55 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 1400 |
| Key inclusion criteria | 1. 55 to 80 years old (inclusive) at the time of ICF signature 2. Has cognitive complaints or objective memory impairment and is being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline, for which the cause is yet unknown, or would be in need of referral for further cognitive evaluation 3. Quick Dementia Rating System (QDRS) score from 0.5 to 12 ( inclusive), with one box memory and recall 4. PI has uncertainty about the underlying etiology i.e. not certain that symptoms are caused by AD 5. No contraindication for performing: clinical interview, cognitive testing, blood and CSF extraction and/or amyloid PET scan 6. Has a person available to be an informant for the Clinical Dementia Rating. An informant can be any person with sufficient contact with the patient (minimum twice a week), who is willing to participate in a clinical interview for this study, is fluent in the language used during the assessment, and has sufficient cognitive health to provide accurate information. 7. Signed informed consent form |
| Key exclusion criteria | 1. A clinical diagnosis of moderate and severe dementia and/or Mini-Mental State Exam (MMSE) score <20 2. Has already undergone advanced diagnostic evaluation including amyloid PET and/or tau PET and/or CSF as part of their routine medical care 3. Presence of active delirium or encephalopathy 4. Shows any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and/or in their future permanence in the study 5. Has received or is receiving any investigational treatment within 5 half-lives or 6 months (whichever is longer) prior to enrollment and during the course of this study before their participation is complete 6. Has received any anti-amyloid medication in a clinical trial setting or other at any time in their life |
| Date of first enrolment | 20/05/2023 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- Australia
- Austria
- Denmark
- England
- Germany
- Scotland
- Spain
- United Kingdom
- United States of America
Study participating centres
3 Redheughs Rigg
Edinburgh
EH12 9DQ
United Kingdom
London
SE5 9RS
United Kingdom
3010
Australia
02472
United States of America
33414
United States of America
85013
United States of America
30501
United States of America
32159
United States of America
32792
United States of America
98052
United Kingdom
33607
United States of America
32751
United States of America
32159
United States of America
37909
United Kingdom
46202
United States of America
02114
United Kingdom
33135
United States of America
10029
United States of America
08005
Spain
08028
Spain
08035
Spain
52074
Germany
10117
Germany
50937
Germany
71034
Germany
68165
Germany
2100
Denmark
1090
Austria
5020
Austria
Sponsor information
Industry
Forrenstrasse 2
Rotkreuz
6343
Switzerland
| Phone | +41 (0)41 799 61 00 |
|---|---|
| rotkreuz.reception@roche.com | |
| Website | https://www.roche.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| 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 | Results will be published in a peer-reviewed journal and at a future conference. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
06/11/2024: Internal review.
08/08/2024: Study's existence confirmed by the HRA.
