Digital approaches for dementia early detection, diagnosis and stratification

Key Features

Dementia research is an ongoing priority for the Department of Health and Social Care (DHSC) and for the NIHR. There is an identified need for robust assessments to validate digital biomarkers as accurate and precise diagnostic or prognostic methods that correlate with established assessments, and to evaluate their clinical and patient use through appropriate studies.

Programme:     National Institute for Heath Research

Award:     Share of up to £2 million

Opens: 12th Nov 2021

Closes: 26th Jan 2022

! This scheme is now closed

Overview

The NIHR Invention for Innovation (i4i) Programme is inviting applications for a dementia-specific funding call aimed at the research and development of digital approaches for the early detection, diagnosis and stratification of individuals with dementia. The i4i Programme supports the research and development of innovative medical technologies that have demonstrated proof-of-concept and have a clear developmental pathway towards new products for ultimate NHS use.

Dementia research is an ongoing priority for the Department of Health and Social Care (DHSC) and for the NIHR. There is an identified need for robust assessments to validate digital biomarkers as accurate and precise diagnostic or prognostic methods that correlate with established assessments, and to evaluate their clinical and patient use through appropriate studies.

Entry Point Requirements

  • At least 1 DBD with proof-of-concept and a technical approach (for example, using statistical, machine learning, deep learning or other data engineering methods) that can be used to interrogate the DBD’s clinical relevance.

Please note that the proof-of-concept (PoC) for the selected digital biomarker/s should demonstrate a potential for use as an early warning sign or risk/susceptibility indicator in the appropriate patient population. The PoC data should ideally have been generated from a minimum of 50 subjects and must be adequately described within the funding application form. However, where less PoC data has been obtained, applications should fully justify the readiness of the proposed innovation for this funding.

  • The selected digital biomarker/s should leverage technologies for data collection such as clinical databases (for example, electronic health records), smartphone, tablet or desktop applications (for example, eye-tracking software), wearables (for example, smart watches), sensory (for example, smart home systems, sleep sensors), or VR/AR platforms (for example, for interactive predefined tasks).

This call encourages multi-disciplinary teams across different organisations and healthcare settings to address these priorities, harness innovation and support a step forward in the management of dementia.

Research Priorities

Digital biomarkers are objective physiological and behavioural measurements of key functions affected by memory disorders and dementia, that are collected by means of digital approaches. Examples include speech and language, sensory acuity, eye movement, motor function, keystroke dynamics, gait, sleep patterns, and cognitive processing. Digital biomarkers offer a unique opportunity to collect longitudinal, consistent measurements over long periods of time and monitor progression of the condition, through non-invasive assessments that do not rely solely on clinical facilities for follow-up and timely detection.

The priorities below present identified unmet needs and form the scope of the i4i Dementia funding call. Please click here for further information.

  • Prediction, early detection and diagnosis of dementia
  • Stratification of people at risk of developing dementia or the subtyping and prognosis of dementia patients

Funding Call

Applicants are invited to submit proposals addressing one or both of the above-mentioned research priorities.

The competition will support proposals covering any of the following aims:

  • the large-scale pragmatic validation of digital biomarkers for dementia (DBDs);
  • the development of DBDs into advanced diagnostic or prognostic prototypes or products;
  • clinical evaluations toward near market-ready solutions

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.

 

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