Usher Institute

Real world Outcomes across the Alzheimer’s Disease spectrum for better care: Multi-modal data Access Platform – the ROADMAP project

This project aimed to provide the foundation for an integrated data environment and framework for real-world evidence in Alzheimer’s disease.

Summary (Research in a nutshell)

The health care challenge facing Europe of an ageing population, rising costs, and need for specialised treatments is nowhere more acute than for dementia, with Alzheimer’s disease as the leading cause of this neurodegenerative condition. Real-world evidence, produced from the use of real-world data, can help inform regulators, health care providers, payers, the pharmaceutical industry, and scientists in decision making regarding the re-purposing of current, or development of new treatments. Real-world data relates to patient health care records, disease registries, and medical claims or billing records. Currently, there is a lack of an integrated data environment, in addition to guidance, for the use and interpretation of real-world evidence in Alzheimer’s disease.

The European Union, with the world’s most diverse and sophisticated health care systems, is uniquely positioned to develop and exploit technologies to support the collection and use of real-world evidence. ROADMAP brought together 26 partners from across Europe to develop a set of consensual, priority outcomes and data integration tools related to Alzheimer’s disease, as well as guidelines on the handling and interpretation of real-world data, among other goals. Outcomes are the results that a treatment might have, e.g. improvements to symptoms associated with dementia, like memory, language use, and everyday functioning. 

The ROADMAP consortium was divided into eight work packages, each being co-led by a partner from academia or patient association, and a partner from industry.

The role of work package 2, co-led by Professor Cathie Sudlow (University of Edinburgh) and Christin Bexelius, PhD (F. Hoffmann‐La Roche Ltd), was to:

  1. Identify priority sets of real-world dementia outcomes, focussing on Alzheimer’s disease across the disease spectrum, from the perspectives of those with the disease, their supporters, and health professionals.
  2. Identify what constitutes a meaningful delay in disease progression from their perspectives.
  3. Based on these findings, identify gaps between data requirements and currently available data.

In aid of these ambitious tasks, work package 2 conducted systematic reviews, surveys, and qualitative interviews, which were synthesised into a series of deliverables:

Deliverable 2.1: A pragmatic literature review – the first list of priority real-world evidence relevant outcomes for Alzheimer’s disease.

Deliverable 2.2: A systematic literature review of published and unpublished data identifying important and relevant outcomes in Alzheimer’s disease and criteria for disease progression.

Deliverable 2.3: Stakeholder generated lists of priority, real-world evidence relevant outcomes for Alzheimer’s disease, through stakeholder surveys and patient and public involvement consultations.

Deliverable 2.4: A disease progression and outcomes classification matrix.

Deliverable 2.5: A gap analysis to map consensus priority outcomes with the available real-world data.

Key people

Name Role
Cathie Sudlow Work package 2 co-lead
Claire Tochel Data Analyst
Michael Smith Research Assistant


Michael Smith, Research Assistant


Key publications

A full repository of ROADMAP publications from the entire consortium can be found on the ROADMAP website.

Gallacher J, de Reydet de Vulpillieres F, Amzal B, Angehrn Z, Bexelius C, Bintener C, Bouvy JC, Campo L, Diaz C, Georges J, Gray A, Hottgenroth A, Jonsson P, Mittelstadt B, Potashman MH, Reed C, Sudlow C, Thompson R, Tockhorn-Heidenreich A, Turner A, van der Lei J, Jelle Visser P, on behalf of the ROADMAP consortium. Challenges for Optimizing Real-World Evidence in Alzheimer’s Disease: The ROADMAP Project. Journal of Alzheimer's Disease. 2019(Preprint):1-7.

Tochel C, Smith M, Baldwin H, Gustavsson A, Ly A, Bexelius C, Nelson M, Bintener C, Fantoni E, Garre-Olmo J, Janssen O, Jindra C, Jorgensen IF, McKeown A, Ozturk B, Ponjoan A, Potashman MH, Reed C, Roncancio-Diaz E, Vos S, Sudlow C, on behalf of the ROADMAP consortium. What outcomes are important to patients with mild cognitive impairment or Alzheimer's disease, their caregivers, and health-care professionals? A systematic review. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring. 2019 11:231-247.


Full details of the partners, project structure, final reports, publications and more can be found on the ROADMAP website

Key Collaborations

Partners across academic institutions, industry, and patient organisations collaborated closely with work package 2, including:

  • Aarhus Universitet
  • Alzheimer Europe
  • Biogen
  • Eli Lilly and Company Ltd
  • F. Hoffmann-La Roche Ltd
  • Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina
  • GE Healthcare
  • Goeteborgs Universitet
  • Janssen Pharmaceutica NV
  • Københavns Universitet
  • London School of Economics and Political Science
  • National Institute for Health and Care Excellence
  • NHS Lothian
  • Oxford Health NHS Foundation Trust
  • Takeda Development Centre Europe Ltd
  • Universiteit Maastricht
  • University of Oxford

Partners and Funders

This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking under the grant agreement no.: 116020 (“ROADMAP”). This Joint Undertaking received support from the European Union’s Horizon 2020 research and innovation program and EFPIA.


Start date: September 2016

End date: October 2018


Scientific themes

Real-world data, Alzheimer’s disease, dementia, mild cognitive impairment, data sharing, health policy, epidemiology, health outcomes, ethics.

Methodology keywords

Outcomes definition, systematic review, surveys, patient and public involvement, focus groups, disease modelling, quantitative, qualitative.