Biomark APD: The Biomarkers for Alzheimer’s disease and Parkinson’s disease
Alzheimer’s and Parkinson’s diseases (AD and PD) are the two most common neurodegenerative conditions. In Europe, more than 8 million individuals have AD or PD. Current treatments are symptomatic but do not stop the underlying disease process. Using biomarkers, we can detect biochemical changes that show when neurons start to die. There are also biochemical tests for brain changes that are specific to AD and PD. Studies suggest that such abnormalities start to appear 10-20 years before onset of symptoms. If we want to do something substantial about these diseases, we need to diagnose them early, before too many neurons have been lost, and then treat them with drugs that inhibit the destructive process. Established biomarkers exist for early AD and promising candidates are underway for PD. However, a major problem today is the lack of standardisation regarding exactly how to perform and use the biomarker tests.
The BIOMARKAPD Project, involving 45 Research Centres across 19 European Counties and 1 from Canada, is aimed to standardise and to collect biomarker samples, to perform the measurements and to interpret the results of AD and PD biomarkers. During the Project will be also created a biobank with samples from well characterised AD and PD patients, including patients in very early disease stages, as well as neurologically healthy controls. These samples will be used to develop new and better assays and to test new and better biomarker candidates. Finally, BIOMARKAPD project will develop certified reference materials that can be used to harmonise assays that are used to measure the different biomarkers. The deliverables of the proposal will have a major influence on clinical research and drug development for neurodegenerative conditions in general and for AD and PD in particular. Results from BIOMARKAPD will make Europe world-leading in this arena.
Link: centers involved.
The project has 4 main parts:
Part A. Protocol development: in this part protocols will be developed for the pre-analytical and analytical procedures and for the use of biomarkers in clinical practice and trials.
This part consists of 5 tasks:
- A1 Development of pre-analytical protocols.
- A2 Development of assay qualification protocols.
- A3 Development of analytical protocols.
- A4 Development of protocols for the use of biomarkers in diagnosis.
- A5 Development of protocols of for the use of biomarkers in trials.
Part B. Protocol validation: in this part, it will be tested whether the protocols are feasible in practice and whether the protocols indeed reduce variability in biomarker results among sites. If the validation studies raise concerns on the feasibility or variability, the protocols will be adjusted and the protocol validation will be repeated.
This part consists of 2 tasks:
- B1 Validation of pre-analytical protocols.
- B2 Validation of analytical protocols.
Part C. Protocol implementation: in this part the final protocols will be implemented. Technicians from laboratories that perform the assays will be trained and a selection of laboratories will be certified. In addition, training sessions for clinicians will be organised in each country to teach and train them how to order and interpret the biomarker findings.
This part consists of 2 tasks:
- C1 Implementation of pre-analytical protocols.
- C2 Implementation of analytical protocols.
Part D. Support actions: in order to develop, validate and implement the protocols a number of support actions are needed. These support actions also include the validation of new platforms or biomarkers.
This part consists of 8 tasks:
- D1 Qualification of the AD and PD liquoral biomarkers analisys methods.
- D2 Preparation of correctly classified samples for the quality check.
- D3 Analysis of pre-analytical and analytical confounders.
- D4 Set-up of biobanks.
- D5 Validation of technical platforms.
- D6 Validation of new biomarkers.
- D7 Decision analytical modelling and cost-effectiveness analysis.
- D8 Validation against imaging markers.