Clinical Trials For Advancing Innovative Interventions For Neurodegenerative Diseases
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2027-02-DISEASE-14-two-stage
- Programme
- Cluster 1 - Health (Two stage - 2027)
- Programme Period
- 2021 - 2027
- Status
- Forthcoming (31094501)
- Opening Date
- February 10, 2027
- Deadline
- April 13, 2027
- Deadline Model
- two-stage
- Budget
- €39,300,000
- Min Grant Amount
- €10,000,000
- Max Grant Amount
- €10,000,000
- Expected Number of Grants
- 4
- Keywords
- HORIZON-HLTH-2027-02-DISEASE-14-two-stageHORIZON-HLTH-2027-02-two-stageBrain researchClinical medicineClinical neurologyClinical researchClinical trialsCognition (e.g. learning, memory, emotions, speech)DementiaInterventional clinical trialsMolecular and cellular neuroscienceNeurobiologyNeurochemistry and neuropharmacologyNeurodegenerative disordersNeuroinflammatory disordersNeurological disorders (e.g. Alzheimer's disease, Huntington's disease, Parkinson's disease)NeurologyNeurosciences (including psychophysiology)Public health
Description
Expected Outcome:
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes:
- The scientific and clinical communities make effective use of state-of-the-art knowledge, data, technologies, tools, methods, best practices, and trainings to underpin and complement the development of innovative interventions aimed at more effective treatments for neurodegenerative diseases.
- The scientific and clinical communities benefit from the exchange of data, knowledge and best practices, thereby strengthening their collaboration in the EU, the Associated Countries and beyond.
- The scientific and clinical communities make wide use of relevant databases and/or integrate them with existing infrastructures for storage and sharing of collected data according to FAIR[1] principles, thereby encouraging further use of the data.
- Policymakers, funders, scientific and clinical communities, patient organisations, regulators, and other relevant bodies are informed of the research advances made and the requirements for a widespread implementation of the innovative therapeutic interventions and complementary approaches.
- Patients and caregivers are constructively engaged with the research, ensuring that their needs are catered for, with the aim of tangibly benefitting from the interventions.
Scope:
Neurodegenerative diseases are a high burden for patients, caregivers, health systems and society. Given the limitations with current therapeutic solutions, including that they primarily address symptoms rather than underlying causes and can have serious side effects, together with the increasing prevalence of neurodegenerative diseases in an aging population, there is a huge need to develop more innovative, safer and more effective therapeutic solutions for these diseases. To further enhance their safety and effectiveness, the therapeutic solution based on an active substance should be combined/complemented with another multidisciplinary approach (e.g. lifestyle changes, cognitive training, rehabilitation therapies). Together this innovative intervention should lead to an improved quality of life and reduce the societal impact of these diseases.
Rare neurodegenerative diseases are excluded[2].
Proposals should address most of the following aspects:
- Perform rigorous early-stage[3] clinical trials into the safety and efficacy of the innovative interventions and their mode of administration, ensuring adequate cohorts/sample sizes with adequate representation of the patient population, including in terms of age, sex and ethnicity.
- Through the clinical trials and to the extent possible of additional studies, gain further insight into the potentially novel mechanism(s) of action of the innovative therapies and complementary approaches. This could entail analyses of imaging (e.g. MRI, ultrasound, nuclear imaging), as well as physiological, molecular, biochemical or omics signatures revealing potential perturbations prior to the intervention and recovery/improvement thereafter, and it could lead to the development of surrogate endpoints. This insight should open the path to more personalised interventions and approaches.
- Use and/or develop technologies, including digital ones (e.g. (generative) Artificial Intelligence - AI[4], wearable technologies) to help implement and monitor the long-term efficacy of the intervention(s), as well as manage the disorder and/or monitor their progression (e.g. with unobtrusive technologies suitable for patient monitoring at home and in real-world conditions), whilst also ensuring they are bias-free, inclusive, and ethically sound.
- Utilise existing data, biobanks, registries and/or cohorts, together with the generation of new data that should be managed in line with the FAIR principles.
- Engage all relevant stakeholders (especially patients and patients’ representatives for the disease, caregivers, clinicians, counsellors, regulators, etc.) to design end-user optimised interventions, applying gender-sensitive and intersectional approaches.
- Advance research by leveraging already existing and emerging state-of-the-art research infrastructures (e.g. EuroBioImaging[5], European Genomic Data Infrastructure[6], ECRIN[7], EATRIS[8], EBRAINS[9], BBMRI[10], etc.), as well as results stemming from EU-supported research projects, where applicable[11].
- Engage with national public health authorities and regulators to ensure a robust development pathway and further uptake of the intervention.
The participation of start-ups, micro, small and medium-sized enterprises (SMEs)[12] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation.
Funded projects should liaise with the future co-funded European Partnership for Brain Health[13] (covered by topic HORIZON-HLTH-2025-02-DISEASE-01: “European Partnership for Brain Health”) once launched.
The topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.
All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. Therefore, proposals should include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase.
Applicants should provide details of their clinical studies[14] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.
[1] See definition of FAIR data in the introduction to this Work Programme part.
[2] Rare diseases, as defined by the European Union Regulation on Orphan Medicinal Products (1999), being a disease that affects not more than 1 person per 2000 in the European population (https://www.orpha.net/).
[3] For pharmacological-based interventions: phase 1 and/or phase 2 clinical trials.
[4] Generative AI is a type of AI technology that can generate various forms of new content such as text, images, sounds, and even code, such as for programming or gene sequencing (https://ec.europa.eu/newsroom/dae/redirection/document/101621).
[5] https://www.eurobioimaging.eu
[6] https://gdi.onemilliongenomes.eu
[10] https://www.bbmri-eric.eu
[11] Consult databases e.g. CORDIS (https://cordis.europa.eu) & the JPND Research Database (https://neurodegenerationresearch.eu/search-our-database).
[12] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361
[13] https://www.brainhealth-partnership.eu
[14] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.
Destination & Scope
Topics under this destination are directed towards the Key Strategic Orientation 3 “A more resilient, competitive, inclusive, and democratic Europe” of Horizon Europe’s strategic plan 2025-2027[1].
Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “healthcare providers improve their ability to tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) thereby reducing the disease burden on patients and enabling healthcare systems to perform more effectively. It can be achieved through better understanding, prevention, diagnostics, treatment, management, and cure of diseases and their co- and multi-morbidities, more effective and innovative health technologies and medical countermeasures, better ability and preparedness to manage pandemic and/or epidemic outbreaks, and improved patient safety”.
Communicable and non-communicable diseases pose a significant health, societal, and economic threat worldwide, causing premature deaths and disabilities. Despite being largely preventable, only 6% of healthcare budgets are spent on prevention[2]. To address this, there is an urgent need to develop new public health interventions, preventive, diagnostic, and therapeutic approaches, alternatives to antimicrobials, as well as to improve existing preparedness and response strategies to create tangible impacts, considering sex/gender-related issues. To address these challenges, Research and Innovation will require international cooperation to leverage global expertise, access world-class research infrastructures and invest in priority needs, aligning with other funders of international cooperation in health Research and Innovation. The continuation of international partnerships and cooperation with international organisations is particularly needed to combat infectious diseases and respond to public health needs, including rare diseases and the global burden of non-communicable diseases.
In this Work Programme part, Destination “Tackling diseases and reducing disease burden” will focus on major societal challenges linked to the Commission's Political Guidelines for 2024-2029[3], such as the fight against non-communicable and communicable diseases, mental health, preparedness and response to and surveillance of health threats and epidemics, reduction and treatment, of Antimicrobial-Resistant (AMR) infections, coherent also with wider EU initiatives such as the European Medical Countermeasures Strategy[4] and the forthcoming Critical Medicines Act[5]. In particular, the topics under this destination will support activities aiming at: i) new treatment and disease management options to reduce burden on non-communicable diseases and long-term conditions after post-bacterial and post-viral infections; ii) improve and protect mental health of children and young adults; iii) new prevention and treatment options for infectious diseases with epidemic potential; iv) innovative therapies for AMR critical pathogens; and v) support to second phases of the co-funded European Partnership on Rare Diseases[6] and the co-funded European Partnership for Pandemic Preparedness[7].
To increase the impact of EU investments under Horizon Europe, the Commission encourages cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities, such as participating in joint workshops, exchanging knowledge, developing and adopting best practices, or undertaking joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic, as well as between projects funded under different topics, Clusters, or Pillars of Horizon Europe. For example, synergies could be sought with projects funded under the European health research infrastructures (Pillar I of Horizon Europe), the EIC[8] strategic challenges on health (Pillar III of Horizon Europe), or with projects on themes that cut across the Clusters under Pillar II of Horizon Europe, such as health security/emergencies under Cluster “Civil Security for Society”, Artificial Intelligence (AI)-based tools and technologies under Cluster “Digital, Industry and Space”, or antimicrobial resistance under Cluster “Food, Bioeconomy, Natural Resources, Agriculture and Environment”.
The Commission aims to foster synergies between Horizon Europe and other EU programmes. To this end, applicants are encouraged to explore the funding opportunities available through the EU4Health Programme (2021-2027)[9], the EU's public health programme, as a means of capitalising on potential collaborations and maximising impact.
Expected impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to tackling diseases and reducing disease burden, and more specifically to several of the following impacts:
- Disease burden in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative preventive, diagnostic and therapeutic approaches, digital and other people-centred solutions for healthcare.
- Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and wellbeing are promoted, and the targets of the World Health Organization (WHO) Global Action Plan for the Prevention and Control of non-communicable diseases[10],[11] are attained, with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs)[12].
- Healthcare systems benefit from strengthened Research and Innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation.
- Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide[13],[14],[15].
- Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies).
Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination. For additional information please see “Restrictions on the participation of legal entities established in China” found in the Annex B of the General Annexes of this Work Programme.
The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers[16] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details.
[2] Preventive healthcare expenditure as a share of the current expenditure on healthcare: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=File:Preventive_healthcare_expenditure_as_a_share_of_current_expenditure_on_healthcare,_2021_(%25)_HCE2024.png
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[3] https://commission.europa.eu/about/commission-2024-2029_en
[5] https://health.ec.europa.eu/publications/proposal-critical-medicines-act_en
[6] https://cordis.europa.eu/project/id/101156595, https://erdera.org
[7] https://cordis.europa.eu/project/id/101226682, https://beready4pandemics.eu
[9] https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/eu4health_en
[10] https://www.who.int/publications/i/item/9789241506236
[12] Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death.
[13] WHO global action plan on antimicrobial resistance, 2015
[14] EU One Health Action Plan against AMR, 2017
[15] https://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agencies
[16] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).
Eligibility & Conditions
General conditions
1. Admissibility Conditions, proposal page limit and layout
Applicants submitting a proposal for a blind evaluation (see General Annex F) must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first-stage application (see General Annex E).
2. Eligible Countries
Eligible countries are described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
3. Other Eligibility Conditions
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).
Subject to restrictions for the protection of European communication networks.
Other eligibility conditions are described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds
The first-stage proposals of this topic will be evaluated blindly.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
5b. Evaluation and award: Submission and evaluation processes
For the first stage, the thresholds for each criterion will be 4 (Excellence) and 4 (Impact). The overall threshold applying to the sum of the two individual scores will be set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to four times the available budget, and not less than three and a half times the available budget.
For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement
Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants
The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5.
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions
Specific conditions are described in the specific topic of the Work Programme.
Application and evaluation forms and additional documents:
Application and evaluation form templates
Standard application form (HE RIA IA Stage 1 BLIND) - the application form specific to this call is available in the Submission System
Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE RIA, IA and CSA Stage 1 BLIND) - will be used with the necessary adaptations
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
Model Grant Agreement (MGA)
Call-specific instructions
Additional documents
HE Main Work Programme 2026-2027 – 1. General Introduction
HE Main Work Programme 2026-2027 – 4. Health
HE Main Work Programme 2026-2027 – 15. General Annexes
HE Framework Programme 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Frequently Asked Questions About Clinical Trials For Advancing Innovative Interventions For Neurodegenerative Diseases
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’).
Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.
IT Helpdesk – contact the Funding & Tenders Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.
European IPR Helpdesk assists you on intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.
The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
Partner Search help you find a partner organisation for your proposal.
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