The BioFINDER-Preclinical AD study (NCT06121544) launched in 2022 and extends the previous cohorts of BioFINDER-1 and BioFINDER-2 studies. In contrast to these studies, the BioFINDER-Preclinical AD study focuses solely on the pre-symptomatic phase of Alzheimer’s disease (AD). During this pre-symptomatic phase of the disease (often also termed “preclinical” AD), amyloid-b and tau pathology builds up in the brain over about one to two decades before onset of cognitive impairment. It is very likely that novel disease-modifying treatments will be most effective if they are administered in the pre-symptomatic phase of the disease, before too extensive and irreversible damages to the brain occur. However, to successfully develop such effective treatments we need to both gain increased knowledge of the characteristics of preclinical AD as well as identifying which individuals in the pre-symptomatic phase of the disease that are most likely to benefit from treatment, and therefore should be invited to participate in clinical treatment trials. The BioFINDER-Preclinical AD study and the creation of a Trial Ready Alzheimer Cohort is a way to meet these needs.
General aims
- Determine which factors (including demographic, genetic, imaging, fluid biomarkers) that are associated with faster clinical deterioration.
- Identify prognostic algorithms identifying those with pre-symptomatic AD who will worsen in tau pathology and develop objective cognitive impairment in the coming years and thereby benefit most from interventions against AD pathology.
- In depth characterize the temporal (CSF and plasma) and spatiotemporal (PET and MRI) evolution of key biomarkers during the pre-symptomatic and early clinical phases of AD to understand the interactions of different key pathologies and their effects on cognitive decline. This might facilitate selection of new therapies (or combinations of therapies) for trials in pre-symptomatic AD.
- Identify different pathology-based subtypes of AD, which exhibit different clinical phenotypes and disease trajectories. Such subtypes might respond differently to different types of therapies.
- Develop and validate novel biomarkers, such as CSF and blood biomarkers for different tau isoforms, misfolded a-synuclein, astrogliosis, neuroinflammation, lipid metabolism and different aspects of neurodegeneration.
- Develop and evaluate optimal procedures to disclose AD biomarker information to healthy volunteers and those with mild cognitive symptoms.
- Identify individuals with pre-symptomatic AD who can be part in a Trial Ready cohort, and potentially enrolled in future trials evaluating disease modifying therapies (such trials will necessarily be subject to specific applications to regulatory authorities).
