HORIZON EUROPE
Europeo
Specific Challenge:The clinical paradigm for Alzheimer’s disease (AD) largely engages patients in the later clinical stages of disease, with the majority of patients and caregivers not seeking and/or receiving care until moderate or severe dementia has ensued. The current clinical paradigm does not support or emphasise the need for early detection, diagnosis or action when symptoms of AD first begin. To compound the issue, many physicians are reluctant to provide a diagnosis, because they perceive AD as an incurable disease without adequate treatment and supports. This lack of urgency not only currently compromises the quality of patient care, but also robs patients of access to available support resources and services. This lack of system preparedness for early action will also dramatically impact patient care once disease modifying agents are available.
The scientific community, many regulatory agencies, and advocacy groups are now aligned on the understanding that AD is a pathophysiologic neurodegenerative brain disorder that begins one or two decades prior to symptomatic presentation. Initial efforts in AD treatment development and clinical diagnostic paradigms foc...
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Specific Challenge:The clinical paradigm for Alzheimer’s disease (AD) largely engages patients in the later clinical stages of disease, with the majority of patients and caregivers not seeking and/or receiving care until moderate or severe dementia has ensued. The current clinical paradigm does not support or emphasise the need for early detection, diagnosis or action when symptoms of AD first begin. To compound the issue, many physicians are reluctant to provide a diagnosis, because they perceive AD as an incurable disease without adequate treatment and supports. This lack of urgency not only currently compromises the quality of patient care, but also robs patients of access to available support resources and services. This lack of system preparedness for early action will also dramatically impact patient care once disease modifying agents are available.
The scientific community, many regulatory agencies, and advocacy groups are now aligned on the understanding that AD is a pathophysiologic neurodegenerative brain disorder that begins one or two decades prior to symptomatic presentation. Initial efforts in AD treatment development and clinical diagnostic paradigms focused on the most clinically evident stage of AD, dementia. The dementia stage is now clearly identified as a late stage in the pathological progression of the disease. Despite a shift in the scientific paradigm to address the disease in its earlier pathological stages such as mild dementia, prodromal AD and even at the time of preclinical pathology, the front line of clinical management continues to focus on the later stages of the disease, with most diagnoses occurring at the moderate and severe stages of dementia. Yet, at the same time, treatment development has clearly begun a shift to an earlier paradigm, seeking volunteers at earlier stages of disease (prodromal, mild, and in some geographies, preclinical). This dissociation between when patients are identified by their healthcare providers as having AD and the patient populations needed to develop disease modifying therapies at earlier stages of disease is a significant impediment to successfully accomplishing clinical research with a goal of discovering impactful treatments.
However, clinical trial participation is not the only benefit to a timely diagnosis. Many advocacy groups and AD specialists are now demonstrating that, aside from the clinically available therapies which provide modest benefit, non-pharmaceutical interventions are also available and beneficial for the caregiver and patient. For example, for the patient, increased socialisation, exercise, art programs, nutritional education, cognitive therapy, and clinical trial participation can prove valuable. For the caregiver, appropriate counselling on a variety of topics (such as driving safety/cessation, finances, life planning, non-pharmacological management of behavioural symptoms) can provide substantial improvement in quality of life for both the patient and caregivers. To have the greatest impact, these interventions are best employed in the earliest clinical stages of disease to maximize the benefit throughout all stages of disease. With over 34 million AD patients worldwide, the current clinical paradigm of diagnosing AD in later clinical stages does a disservice. By this time, patients have often declined to the point they lack the insight and judgment to play a participative role in their care, and certainly have declined too far to have participation in clinical trials be an option that they and their loved ones can consider. The field must shift to greater public awareness of the importance of an early diagnosis and improved medical efficiency in identifying AD as soon as clinical symptoms emerge.
Not only could these efforts improve clinical access to treatment and support resources and patient engagement earlier in the stages of disease, they will also help widen the funnel for clinical trial recruitment and earlier treatment development.
There is a need to proactively assess the obstacles to patient presentation and diagnosis. There is a need to determine optimal patient engagement practices in the AD healthcare and clinical trial environments to evolve the field toward improved early patient identification and clinical research involvement. In order to achieve these goals, several broad steps are required:
to collect data on a new early paradigm for diagnostic and therapeutic advancements to help local decision makers; to broaden the understanding of the experience of AD beyond the last few years of its course; to increase the connectivity between AD thought leaders and AD clinicians; to create a sense of urgency for the societal and economic impact of AD, especially among policymakers and governments.
Scope:Objectives (restricted scope is expected for Phase 1)
to establish multiple key regional project sites (demonstration sites) across Europe to identify and test models of efficient earlier identification of mild AD dementia and prodromal AD patients, and awareness of AD risk; to assess key tools, mechanisms and processes for community engagement and patient identification and resource utilization in various communities; to compare and contrast various patient access models and how they contribute to improved detection, diagnosis, and clinical research in these communities; based on findings, to establish archetypes of patient access models for implementation in similar communities, in synergy and collaboration with existing country specific government and non-government stakeholders; to advocate and distribute access models for broader application and for replication. Applicants are expected to address all the above objectives in the Short Proposal (within the available duration and maximum IMI2 contribution) and demonstrate a relevant strategy for achieving them, through partnership with the industry consortium.
This will have to be fully developed with the industry consortium and or associated partners in the Full Proposal.
Expected Impact:The intention of this action is to initially assess key metrics and access models for prioritization applicability. Methods and metrics should be analysed to measure efficiency and efficacy, and categorized into archetype models customized for various community types. Once successful archetype programs of paradigm shift are identified in successful models, they can be replicated in similar communities. This will be used to facilitate further development of independent efficient care models that engage more patients, engage them earlier in the course of disease, and provide access to a wider array of resources and aimed at improving access and enrolment in clinical research programs.
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Características del consorcio
:
La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
The budget breakdown for this call is given at the end of the Call topics text in the Call Conditions section, as well as the following information:
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and threshold: described in IMI2 Manual for submission, evaluation and grant award
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Research and Innovation Action:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Standard proposal template
Standard evaluation form
Annotated Model Grant Agreement
Please read carefully all provisions below before the preparation of your application.
The budget breakdown for this call is given at the end of the Call topics text in the Call Conditions section, as well as the following information:
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and threshold: described in IMI2 Manual for submission, evaluation and grant award
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Research and Innovation Action:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Standard proposal template
Standard evaluation form
Annotated Model Grant Agreement
Información adicional de la convocatoria
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