Accelerating the Development and Regulatory Acceptance of Digital Measures in Alzheimer's and Related Dementias (ADRD), Maximizing the Impact of these Novel Measures on Patients and their Families.

Alzheimer's and related dementias (ADRD) represent a significant global health challenge with limited treatment options and a growing need for sensitive and objective measures of disease progression and treatment response. Early identification of patients and disease classification are a major challenge with many patients going undiagnosed, particularly in the early stage of the disease. Digital measures, including wearable sensors, mobile applications, and cognitive assessments, offer the potential to revolutionize ADRD care by providing continuous, real-world insights into patients' cognitive and functional abilities.

DiMe and IMI RADAR-AD, in collaboration with industry and academic partners, have pioneered early research in this space, identifying core digital measures and testing technologies, generating valuable data from patients, and defining relevant terminology and ontologies for meaningful aspects of health (MAHs) and concepts of interest (COIs) in ADRD. This early work provides a crucial starting point for developing robust and standardized digital measures for ADRD and in combining these resources and taking them to the regulators together, we can significantly advance the field of digital measurement in ADRD by helping to build clarity, understanding and confidence.

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DiMe ADRD 

IMI RADAR AD 

Overall Goal:

- Combine and extend the work initiated by DiMe and IMI RADAR-AD to curate a set of foundational measurement definitions.

- Create Target Solution Profiles (technical, analytical and usability standards) for new digital modalities in ADRD that capture the different measurement definitions.

- Assess the completeness of these foundations and identify any remaining gaps from an evidentiary and a regulatory standards perspective.

This collaborative effort aims to optimize the development and regulatory qualification of these measures and take them to the finish line, improving patient care by enabling drug approvals to be based on the most meaningful evidence that matters to patients and facilitate drug development by helping companies identify the right population through more sensitive and relevant measures.

With standardized target solutions profiles (TSP) in existence and well-defined measures approved by regulators, we aim to usher in a new world where effective patient centered digital solutions are in the hands of patients and delivering impact across R&D, diagnostics, and patient care.

Specific Objectives:

Consolidate Existing Evidence: Gather and synthesize the core digital measures, terminology, and ontologies defined by DiMe, along with relevant data and evidence from IMI RADAR-AD and other sources.

Develop Measurement Definitions: Curate comprehensive Measurement Definitions within the DEEP Stack Model for each core digital measure in ADRD, ensuring a structured and standardized representation.

Create TSPs: Collaboratively develop device-agnostic TSPs for various modalities (e.g., wearables, cognitive assessments, digital biomarkers) that can capture the defined measurement definitions. These TSPs will outline usability, technology, and analytical standards.

Engage with Regulators: Present the curated measurement definitions and TSPs to regulatory bodies (FDA, EMA, Notified Bodies, HTA...) as a multi-stakeholder team to seek feedback and guidance on qualification pathways for these digital measures in ADRD.

Potential Benefits:

Accelerated Development: Streamline the development and validation of digital measures for ADRD by leveraging the combined knowledge and resources of DiMe, IMI RADAR-AD, and the DEEP framework.

Standardized Approach: Promote consistency and comparability of digital measures across different studies and initiatives, facilitating data aggregation and analysis.

Regulatory Alignment: Increase the likelihood of regulatory acceptance across agencies and qualification of digital measures in ADRD by proactively engaging with regulatory bodies and addressing their key questions.

Improved Patient Care: Enable earlier detection of disease progression, personalized treatment plans, and improved monitoring of patient response in ADRD.

Efficient Drug Development: Facilitate the use of digital endpoints in clinical trials, potentially leading to more efficient and patient-centric drug development for ADRD.

Call for Collaboration:

This initiative invites active participation from:

Existing DiMe Consortium Members: Pharmaceutical companies, technology providers, academic institutions, and patient advocacy groups involved in the DiMe ADRD pre-competitive consortium can seamlessly transition earlier DiMe work into this new program.

IMI RADAR-AD Partners: Organizations and researchers involved in the IMI RADAR-AD project. Leverage specific IMI/IHI incentives, such as IKAA (In-Kind contributions to Additional Activities) maximizing the impact of these prior investments by ensuring long term sustainability of the research outcomes and the creation of solutions.

Other Stakeholders: Organizations with an interest in advancing digital measures for ADRD, including researchers, clinicians, and regulatory experts.

Ways of contributing to a DEEP collaboration mission:

Contributions can be in the form of funding, time & expertise, or prior work. DEEP's framework simplifies collaboration and provides an effective mechanism for intellectual property and access rights management.

If you have questions, or if your organization is interested in contributing, please reach out to us here: