Actively Recruiting
The Swedish BioFINDER - Preclinical AD Study
Led by Skane University Hospital · Updated on 2026-04-06
800
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
S
Skane University Hospital
Lead Sponsor
L
Lund University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Swedish BioFINDER - Preclinical AD Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 80 years
- For ages 50 to 60, must have at least one risk factor: APOE-ε4 carrier, first-degree family history of dementia with onset before age 75, or known amyloid brain pathology by CSF or PET
- Mini-Mental State Examination (MMSE) score 26 or higher if older than 65; MMSE 27 or higher if aged 50 to 65
- Score 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version
- Able to speak and understand Swedish without needing an interpreter
- For preclinical Alzheimer's subgroup (about 450 participants): amyloid pathology confirmed by cerebrospinal fluid or amyloid PET scans
- For non-preclinical Alzheimer's subgroup (about 150 participants): no signs of preclinical Alzheimer's by cerebrospinal fluid biomarkers or amyloid PET scans
You will not qualify if you...
- Diagnosis of minor or major neurocognitive disorder according to DSM-5
- History of significant brain injury or neurological disease causing lasting cognitive problems
- Major depression, bipolar disorder, or recurrent psychotic disorders within the past year
- Alcohol or substance abuse or dependence within the past year
- Significant unstable systemic illness or organ failure such as terminal cancer
- Unable or unwilling to complete baseline cognitive and biomarker assessments including cognitive tests, blood draws, MRI, and PET scans
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Skåne University Hospital
Malmö, Sweden
Actively Recruiting
Research Team
E
Erik Stomrud, MD, PhD
CONTACT
N
Niklas Mattsson-Carlgren, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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