PROBLEM STATEMENT
Neurodegenerative diseases already stand for more hospital admissions and longer care than all other diseases. Demographic development predicts a further increase in the prevalence of especially irreversible dementias. Early diagnosis and effective treatment methods are necessary (but still non-existent) tools to reduce health care costs and improve the quality of life for patients and their families.
In order to maximize the impact of the project on these parameters, Alzheimer's disease (AD) was chosen as proof-of-concept for the project's approach. AD represents 50-70% of all irreversible dementias, of which the prevalence (1,200 per 100,000) is higher than, for example, for Parkinson (5-10x), multiple sclerosis (10-15x) and amyotrophic lateral sclerosis (200x).
OPPORTUNITIES
The following two opportunities are the reason for the "Memories" project:
- The increasing need for methods for diagnosis of mild cognitive disorders. According to patient associations, early diagnosis will give patients the opportunity to make timely, and conscious, necessary decisions. Professionals in the health care underlines that timely diagnosis and treatment can delay the development of AD, resulting in a better quality of life for patients and their families, and lower costs for society.
- The increasing need for medicines that prevent or delay AD development. The availability of early diagnosis methods opens for the development of new drugs, a development that, despite high prioritization by industry, has not yet produced any tangible results.
JUSTIFICATION FOR THE PROGRAM FIELD
The innovative approach and the multidisciplinary character of this project are in line with the Smart Specialization strategies of the Southern Netherlands and Flanders, NlB and the Key Enabling Technologies. This is facilitated by a goal-oriented cross-border collaboration between 3 private and 3 public parties. This collaboration provides products that enable the parties to grow in a market that is expected to increase annually by 38% (diagnosis) and 7% (therapy) to 64 and 5,900 m € (2020) respectively.
The project makes an important contribution to the program indicators of the program 3 call (1B) through a targeted dissemination of knowledge, technology and product candidates (WP2). Dissemination is aimed, among other things, at companies that prioritize new diagnostics and therapies for the treatment of neurodegenerative brain diseases. Activities that the continuity of insuring the project will be an important part of the dissemination. In particular, the application, evaluation and valorisation of the project results (a diagnostic test, more accurate animal models for AD and new therapy options) are being pursued by industry. As a result, this rather small project can generate considerable added value through the Interreg program.
PROJECT OBJECTIVE
For less than 5% of patients with AD, a diagnosis can be made using specific gene tests. People with mutations in one or more well-characterized genes very likely develop the disease at a young age (> 30 years). However, there are young AD patients without these genetic risk factors, which suggest that unprecedented genes and / or external factors play a role. The majority of AD patients (> 95%) develop symptoms at a higher age (> 60 years) (sAD).
Although the symptoms for both forms of AD are similar, sAD apparently has no genetic background. It is assumed that there is an accumulation of changes in genetic material due to age, and influenceable risk factors such as chemicals (heavy metals, pesticides, anæstetica) and lifestyle (obesity). The mechanisms by which these influenceable risk factors drive the induction and the further development of sAD will be applied in this project in new diagnostic methods and new therapies.
GENERAL GOAL
- A new method for early diagnosis of sAD with industrial applicability The tangible result is a non-invasive blood test which, with sufficient certainty (i) early identification of people with preclinic sAD, (ii) monitors the evolution of the disease, and (iii) evaluate the effectiveness of new drugs.
- Animal models for AD, which can evaluate the therapeutic effect of new drugs by using the biomarker profiles, with more accuracy than current animal models. This objective is important since animal models are part of the legal package for preclinical evaluation during product development.
- Genes and biological processes that can lead to new medicines.
The participating SMEs / academic and project partners are located within the Flanders-South Netherlands region. In this way a strong and effective cross-border consortium can be built up while partners are in close proximity and the lines are short. Each partner in this consortium has a leading position in its research field. The knowledge of the individual partners is, however, insufficient in itself to create the whole of innovations that must be developed independently. However, these innovations can be realized through the synergy that arises when the various partners invest their specific knowledge in this unique collaboration.
- KULeuven has the technology to grow human nerve cells in the laboratory, and to confirm the quality of these cells so that the quality of the obtained results is of a high level.
- UM have the innovative technologies for gene analysis in combination with advanced bioinformatics that are already extensively used in (i) animal-free analysis strategies to demonstrate the effect of chemicals on human biology and (ii) health risk analysis. These technologies will be applied to the human cells of KULeuven to gather the mechanistic information necessary for the identification of possible biomarkers and biomarker profiles.
- ToxGenSolutions has gene profiles for neurotoxicity and specializes in the valorisation of technologies, processes and genetic biomarker profiles. It is ToxGenSolutions's task to prepare the biomarker profiles for industrial use as (i) diagnostic test and (ii) an animal model that can evaluate the effect of new drugs with greater certainty. ToxGenSolutions has 20+ years of experience in project management and coordination of industrial and fundamental research projects in the chemical, pharmaceutical, cosmetic and food industries
- UAntwerpen has years of experience in AD research, and has clinical samples and patient groups for the validation of biomarker profiles required for this project, while Icometrix specializes in non-invasive methods for clinical diagnosis of AD. Both partners play a central role in the mini-validation of the selected biomarker profiles the field of accuracy and industrial applicability.
- reMYND has the animal models that must be used today for the preclinical evaluation of new medicines. This partner is important for the development of more accurate animal models and for the identification of genes or processes that can lead to new medicines. The proposed multidisciplinary private / public approach is thus a unique and very strong point of this project and this is also fully in line with the idea of the Interreg program.