Introduction The therapeutic paradigm in Alzheimer’s disease (AD) has shifted towards secondary prevention, defined as an intervention aiming to prevent or delay disease onset in pre-symptomatic individuals at risk of developing dementia due to AD. The key feature of AD prevention is the need to treat years or even decades before the onset of cognitive, behavioural or functional decline. Prediction of AD risk and evaluation of long-term treatment outcomes in this setting requires predictive modelling and is associated with ethical concerns and social implications. The objective of this review is to identify and elucidate them, as presented in the literature.
Methods and analysis A systematic literature review was conducted in Medline, Embase, PsycInfo and Scopus, and was complemented with a grey literature search. All searches were conducted between March and July 2018. Two reviewers independently assessed each study for inclusion and disagreements were adjudicated by a third reviewer. Data are now being extracted using an extraction sheet developed within the group of reviewers, based on an initial sample of three manuscripts, but allowing for inclusion of newly identified data items (ethical arguments). Data will be analysed qualitatively using a thematic analysis technique. Potential biases in selection and interpretation of extracted data are mitigated by the fact that reviewers come from a range of different scientific backgrounds and represent different types of stakeholders in this ethical discussion (academia, industry, patient advocacy groups).
Ethics and dissemination The study does not require ethical approval. The findings of the review will be disseminated in a peer-reviewed journal and presented at conferences. They will also be reported through the Innovative Medicine Initiative project: Real World Outcomes Across the AD Spectrum for Better Care: Multi-modal Data Access Platform (IMI: ROADMAP).
Trial registration number CRD42018092205.
- qualitative research
- early intervention
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Contributors ZA, CN, HK drafted the protocol. ZA supervised all aspects of the study including document screening, selection, reconciliations, data extraction and management. MN developed search terms. AT, DG, JS, AK and FdRdV made substantial contributions to conception or design of the work and reviewed the manuscript for important intellectual content. All authors approved the final manuscript and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The ROADMAP consortium reviewed this protocol before submission to the journal. ZA is the guarantor of this review.
Funding This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116020 (“ROADMAP”). This joint undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The funder played no role in developing this protocol.
Competing interests This SLR is being conducted as part of the ROADMAP project. ROADMAP is a consortium of academic, public sector and industry partners working collaboratively within the European Union Innovative Medicines Initiative framework. ZA, HK, CN, JS and MN are employees of Analytica Laser which received consulting fees from Novartis and other pharmaceutical companies. DG is an employee of Alzheimer Europe. FdRdV is employee of Novartis Pharma AG. AK is employee of Janssen Pharmaceutica NV.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Novartis Pharma AG and Janssen Pharmaceuticals are industry partners in the ROADMAP project.
Patient consent for publication Not required.