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P29. Neuronet: Diagnosis, patient engagement and trials

Detailed programme, abstracts and poster presentations

P29.1. AMYPAD - Amyloid imaging to prevent Alzheimer’s disease

MOLINUEVO José Luis

BarcelonaBeta Brain Research Center, Barcelona, Spain

Beta-amyloid (β-amyloid) deposition is the considered to be a necessary - albeit not sufficient - step on the path towards development of Alzheimer’s disease (AD). Depiction of brain β-amyloidin vivocan therefore be used to support an early diagnosis of AD and, when recognized in a presymptomatic population, provides an opportunity to consider secondary prevention of AD. Understanding the value of imaging of β-amyloid using positron emission tomography (PET) provides a unique opportunity to achieve 3 major goals: 1) improve the diagnostic workup of patients suspected to have AD and their management; 2) understand the natural history of AD in a presymptomatic stage; and 3) select patients for treatment trials aiming at preventing AD by ensuring more homogeneous and appropriate enrolment.

The Amyloid Imaging to Prevent Alzheimer’s Disease (AMYPAD) will fulfill those goals through two different studies: The Prognostic and Natural History Study (PNHS) and the (Diagnostic and Patient Management Study (DPMS).

The DPNS will determine in a real-world clinical setting for whom β-amyloid imaging is appropriate, when this is best performed and how the resulting information is influencing diagnostic certainty, patient management and ultimately decision trees and cost-effectiveness of dementia care. This will be performed through a randomized clinical trial including subjective cognitive decline, mild cognitive impairment and dementia patients suspected to be due to AD. The DPNS has already included over 450 patients and is aiming to reach 900.

On the other hand, the Prognostic AMYPAD PNHS will study the natural history of amyloid deposition in liaison with the European Prevention of Alzheimer Dementia (EPAD) study. This study will provide a relevant imaging biomarker dimension complementary to CSF amyloid and will complement the phenotyping and disease modelling efforts in EPAD to improve anti-amyloid treatment monitoring. In addition, the PHNS will include additional non EPAD cohorts which include preclinical and prodromal AD participants. The PHNS is expecting to include 2000 participants with a strong focus on longitudinal imaging of cognitively unimpaired subject with intermediate amyloid levels. 

P29.2. EPAD - European prevention of Alzheimer’s dementia consortium

RITCHIE Craig

University of Edinburgh, Edinburgh, United Kingdom

The European Prevention of Alzheimer’s Dementia (EPAD) project is a Pan-European programme of coordinated activity whose objective is to facilitate the effective and efficient development of interventions for the secondary prevention of Alzheimer’s dementia. It is a public: private partnership through funding from the Innovative Medicines Initiative.

The programme has five key components: [1] A Europe wide virtual register of potential research participants to draw into [2] The EPAD Longitudinal Cohort Study (LCS) which has the dual role of generating data for disease modeling and secondly to characterize research participants for potential entry into [3] The EPAD Proof of Concept clinical trial which is a perpetual, phase 2 adaptive clinical trial with multiple concurrent arms accommodating several interventions tested in parallel and sharing placebo between arms. Data derived from the LCS is managed in [4] The EPAD Academy, which also actively promotes the work and development of Early Career Researchers. Finally, the PoC trial and LCS are delivered in [5] an integrated Trial Delivery Centre Network.

The LCS has almost 2,000 research participants screened into it with 30 Trial Delivery Centres expected to be open by the end of 2019. The PoC trial is planned to commence in mid-2020. Research Participant Engagement in design, delivery and operational aspects is key to the success of EPAD. This is formally achieved by local, regional and programme level participants panel and an active and purposeful communication and dissemination strategy focus on the public generally and research participants specifically.

The experience, data and samples arising from the programme are of great benefit to the broad academic community and the Neuronet Project of which EPAD is a foundation partner is now facilitating this.

The background to and ongoing need for EPAD will be presented alongside early outputs from the cohort study.

P29.3. Models of Patient Engagement in Alzheimer´s Disease (MOPEAD): A European project to develop and test innovative patient engagement strategies

BOADA Mercè1, 15, CAMPO Laura2, SHERING Craig 3, RODRIGUEZ-GOMEZ Octavio1, 15, WINBLAD Bengt4, JOHANSSON Gunilla4, WIMO Anders4, JESSEN Frank5, SANNEMANN Lena5, JELLE VISSER Peter6, ZWANN Marissa6, KRAMBERGER Milica7, BONN Jaka7, SIMÓ Rafael8, CIUDIN Andreea8, RODRIGO Adrián9, DUMAS Annette10, GEORGES Jean11, BINTENER Cristophe11, KRIVEC David12, MAGUIRE Peggy13, DRON Amanda14, WYATT Jerry14

1Research Center and Memory Clinic. Fundació ACE, Institut Català de Neurociències Aplicades. Universitat Internacional de Catalunya, Barcelona, Spain, 2Eli Lilly and Company Ltd, Basingstoke, United Kingdom, 3AstraZeneca AB, Delaware, USA, 5Karolinska Institutet, Center for Alzheimer Research, Div. of Neurogeriatrics, Huddinge, Sweden, German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany, 6Stichting VUmc, Amsterdam, Netherlands, 7University Medical Centre Ljubljana, Ljubljana, Slovenia, 8Institut de Recerca Hospital Universitari Vall d’Hebron (VHIR), Barcelona, Spain, 9GMV Soluciones Globales Internet S.A.U., Barcelona, Spain, 10ASDM Consulting, Auderghem, Belgium, 11Alzheimer Europe, Luxembourg, Luxembourg, 12Spomincica — Alzheimer Slovenia, Ljubljana, Slovenia, 13European Institute of Women’s Health, Dublin, Ireland, 14Modus Research and Innovation Ltd, Huddersfield, United Kingdom, 15Networking Research Center on Neurodegenerative Diseases (Ciberned), Instituto de Salud Carlos III, Spain

Background: Numerous studies have shown that a timely diagnosis of Alzheimer´s disease (AD) leads to economic and social benefits. It has been also suggested that an earlier intervention results in a higher probability of success when testing new drugs. Despite this evidence, the diagnosis of AD is still made at late stages in Europe, and even a proportion of cases remain undiagnosed. In this context, raising awareness of the importance of timely diagnosis among the general population and health care professionals is of great importance. The development of new and more efficient patient engagement (PE) strategies should be a priority as well.

Methods: MOPEAD is a European project conducted by a multinational consortium funded by the Innovative Medicines Initiative (IMI), that involves academic partners, IT experts, the pharmaceutical industry and patient associations among others.

MOPEAD aims to test 4 different PE strategies called Runs, which allow us to conduct a pre-screening procedure to identify individuals at risk of cognitive impairment. Run 1 is a pre•screening procedure based on online tools. Run 2 is an Open House Initiative in which individuals are welcome to test their cognition in a memory clinic without the need of a physician´s referral.  Runs 3 and 4 are campaigns to detect cognitive impairment in the primary care setting and diabetes specialist office respectively. The 4 Runs have been conducted simultaneously in 5 European countries (Spain, Netherlands, Sweden, Germany and Slovenia). The individuals at risk identified at each Run have been referred to a MOPEAD memory clinic to undergo a full diagnostic examination enhanced with biomarkers. The data will be analyzed using a big data approach in order to identify the most cost•effective PE strategies.

Results: The grant agreement was signed in October 2016 and the time frame for the completion of the project is 33 months. Recruitment has finished in May 2019. Currently the project is in the data analysis phase and the results will be available for the scientific community and the general public before the end of this year.

Conclusions: MOPEAD is an innovative project based on a synergy of several private and public institutions with different expertise profiles which aims to promote a change in the paradigm of early AD diagnosis and PE strategies.

P29.4. RADAR-AD - Remote assessment of disease and relapse – Alzheimer’s disease

AARSLAND Dag, OWENS Andrew

King’s College London, London, United Kingdom

Alzheimer’s disease (AD) leads to impaired functioning, i.e. the ability to perform activities of daily living. Until recently, measuring the patient’s ability to function has relied on direct clinical observation or caregiver recall at discrete intervals. This limits the reliability and sensitivity to change, which is especially relevant, as functional impairment is required for differentiation between dementia and mild cognitive impairment and is a key outcome for clinical trials in AD. In addition, recent studies have found that subtle functional impairment occurs also during pre-dementia AD. The enormous advances in health-care devices, including portal technologies and wireless communications, allow measuring function in AD patients’ everyday environment using Remote Measurement Technologies (RMTs), providing the opportunity to capture detailed data over numerous time points.

The goal of the Innovative Medicines Initiative (IMI) Remote Assessment of Disease and Relapse (RADAR)-AD project is the development and validation of technology-enabled, quantitative and sensitive measures of functional domains in people with early stage AD. To achieve this, we will, in close collaboration with patient organizations and regulators, select, and if needed, modify, the most relevant available devices that can sensitively measure early and clinically meaningful functional decline in people with AD. We will validate the selected devices in a cross-sectional multicenter observational clinical study of 220 individuals across the AD spectrum.

The RADAR-AD’s tailored combination of devices and smartphone applications, which began early 2019, will act as a powerful new tool in personalised medicine. During the first 6 months we have prioritised functional domains that are declining early in AD and being ranked as important by Alzheimer’s Europe’s Patient Advisory Group. We have selected the most relevant RMTs, and developed the trial protocol, including a substudy that involves technologies being installed in the subjects’ home. RADAR-AD finishes in 2022.

 This session is organised by Neuronet.

 

 
 

Last Updated: Wednesday 28 August 2019

 

 
  • Acknowledgements

    The 29th AE Conference in The Hague received funding under an operating grant from the European Union’s Health Programme (2014-2020). Alzheimer Europe and Alzheimer Nederlands gratefully acknowledge the support of all conference sponsors.
  • European Union
  • Roche
 
 

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