Clinical trials for advancing innovative interventions for neurodegenerative diseases

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, w…bron

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• Clinical trials for advancing innovative interventions for neurodegenerative diseasesEU-portaal (SEDIA) · ec.europa.eu7 jul 2026
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  Clinical trials for advancing innovative interventions for neurodegenerative diseases
  
  Topic: HORIZON-HLTH-2027-02-DISEASE-14-two-stage
  Call: HORIZON-HLTH-2027-02-two-stage — Cluster 1 - Health (Two stage - 2027)
  Programma: Horizon Europe (2021 - 2027)
  
  == Beschrijving ==
  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
  [7] https://ecrin.org
  [8] https://eatris.eu
  [9] https://www.ebrains.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 ==
  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 Europ
  
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