NCT06121544

The Swedish BioFINDER - Preclinical AD Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: —

Summary

This research study aims to examine biomarkers of Alzheimer's disease (AD) as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Skåne University Hospital in Sweden. The study will enroll up to 600 cognitively healthy subjects aged 50 to 80 years with 3/4 having preclinical Alzheimer's disease. Recruitment and enrollment will be ongoing for 2-3 years, and subject participation will be lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Mild Dementia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Plasma tau	Plasma levels of different p-tau and np-tau species
DIAGNOSTIC_TEST	Plasma β-Amyloid 42/40 (Aβ42/Aβ40)	Plasma levels of Aβ42/Aβ40 ratio
DIAGNOSTIC_TEST	Flutemetamol F18 Injection	Positron emission tomography (PET) imaging of amyloid-β plaques
DIAGNOSTIC_TEST	[18F]-RO6958948 Injection	PET imaging of Tau aggregates
DIAGNOSTIC_TEST	Magnetic resonance imaging (MRI)	Different MRI sequences relevant for brain imaging

Timeline

• Start date: 2022-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-11-08
• Last updated: 2026-04-06

Locations

1 site across 1 country: Sweden