Digital approaches for dementia early detection, diagnosis and stratification

Project Requirements

• For pragmatic validation studies and clinical evaluation studies, standard-of-care comparator/s should be considered (for example, clinical cognitive function assessments, clinical biomarkers, genetic or polygenic risk scores, and so on), alongside a clear description of the study design including the endpoints, target population, data collection and statistical analysis.
• Recruitment of study participants should consider the diversity of patient populations, including those less likely to present memory concerns to a GP, or where there is prevalence of risk factors such as an ageing population, or a lack of local access to dementia services.
• End user (patients, service users, familial carers or other carers) involvement to qualitatively assess product accessibility, acceptability, usability and long-term engagement, and consideration of how the outcomes (early warning alerts, diagnosis, prognostic strata, predictions, and so on) will be read out and integrated into follow-up clinical assessments and/or health records.
• Technical activities may include (but are not limited to): verification of the technical approach (for example, a classifier), algorithm development and refinement, software and hardware development and integration, user interface and/or healthcare professional dashboard design, information governance and interoperability work.
• Clinical activities may include (but are not limited to): comparative trials to validate the clinical relevance of a DBD (or DBDs) or to test the efficacy of diagnostic/prognostic prototypes; and qualitative, real-world evaluations to determine whether the innovation is fit for purpose.
• Where applicable, further eligible project activities may include health economic analyses; CE/UKCA marking and preparations for other regulatory submissions; in-depth market analysis; intellectual property (IP) protection and other relevant commercial activities.

Eligibility

• Project teams must be multidisciplinary, involving relevant collaborations between technology developers, data scientists and clinical staff. We encourage clinical applicants to not only comprise clinicians involved in the diagnosis and treatment of dementia, but also those involved in a target setting (for example, GPs) or in the care of at-risk patient populations (for example, renal, stroke physicians and healthcare professionals).
• The lead organisation must be based in England, and should be best placed among the project parties, to lead the research, and either own or have full access to the background IP.
• The lead organisation and collaborating organisations may be any of the types of eligible organisations listed below. Collaborations may be sought across the UK, as deemed appropriate. The following types of organisations are eligible for funding:
  • SMEs (have a staff headcount no greater than 250 and annual turnover no greater than €50 million, including start-ups and newly spun out companies);
  • NHS service providers (including Trusts, community care providers and tertiary care centres);
  • Primary care providers (including GP practices, primary care networks (PCNs) and GP Federations). Please note that primary care providers should obtain formal sponsorship in order to apply for NIHR funding as the lead organisation, as per the Research Governance Framework (.PDF);
  • Higher education institutions (including universities and research institutes);
  • Not-for-profit organisations (including charities and Community Interest Companies).

• Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements; however, appropriate justification must be provided. Sub-contractors may be based outside of the UK if the required expertise or service cannot be reasonably contracted from within the UK.
• Applicants must review the NIHR standard research contract before application submission, and agree in principle with its core terms and conditions as they are non-negotiable.

Exclusions

• In vitro diagnostics (for example, for blood biomarkers, cerebrospinal fluid, p-tau, neurofilament biomarker levels and amyloid-beta levels, and so on);
• Improving the diagnostic accuracy of existing imaging modalities (for example, MRI, PET, OCT, and so on);
• Proof-of-concept studies;
• Discovery of new digital biomarkers not previously demonstrated to be linked to dementia pathology;
• The digitisation or computerisation of existing neuropsychological tests;
• Assistive and care management technologies (for example, to prevent falls and fractures).

Budget and Duration

• All funding proposals are expected to lead to projects of up to 60 months in duration, and may cost up to £2 million.
• The release of a project’s budget will be subject to stage gates based on project milestones, go/no-go decision points and periodic progress monitoring.
• We cover 100% costs for SMEs, not-for-profit organisations and primary care providers; 100% of the direct research costs for NHS service providers, and 80% FEC for higher education institutions. There are no set rules on the split between collaborators. However, as the contracted organisation, the lead applicant will receive funding payments and would be required to distribute predefined payment shares to the co-applicants (that is, the collaborators) and subcontractors where applicable.