REAL AD – A realistic screening approach for preclinical Alzheimer’s disease

Abstract

AbstractBackgroundFor disease‐modifying treatments to be successful in Alzheimer’s disease (AD), it is essential to identify individuals in the early phases of the disease, characterised by first biomarker abnormalities. At present, most AD diagnoses in Sweden are made within primary care which is not equipped for detecting individuals who are at risk of developing AD dementia. Considering current treatment developments, it will be essential to have access to biomarkers to aid an informed diagnosis already in primary care. REAL AD will evaluate the feasibility of a screening approach for preclinical AD using remote cognitive testing and blood‐based biomarkers in a naturalistic setting.MethodREAL AD is a collaborative initiative between the Swedish Västra Götaland County Council (VGR), VGR Primary Care, the Sahlgrenska University Hospital, the University of Gothenburg and pharmaceutical industry partners. A targeted PR‐campaign will facilitate reaching a recruitment goal of a minimum of 3000 socioeconomically and ethnically diverse individuals aged 50‐80 years without AD dementia. All participants will perform remote cognitive testing at home and undergo blood sampling at a local primary care unit on two occasions. Based on baseline blood biomarker profiles, a subgroup of participants will be enrolled into a validation study and further undergo CSF sampling, neuroimaging and clinical and neuropsychological assessment, also on two occasions.ResultLongitudinal remote cognitive assessment and blood sampling will be conducted at baseline and after 18 months, the blood samples will be analysed for a range of established and novel biomarkers. Within the validation study, results of the screening approach will be validated against established neuropsychological, CSF, MRI and [18F]RO948 tau PET assessments, and the feasibility of implementing this approach in the existing primary care infrastructure will be evaluated. We plan to present first data on recruitment and implementation at AAIC.ConclusionREAL AD aims to evaluate the applicability of a population‐based screening method to detect preclinical AD in a naturalistic setting and to inform the implementation of recent biomarker developments in clinical routine.