Actively Recruiting

Age: 50Years - 80Years
All Genders
NCT06121544

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

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Skåne University Hospital

Malmö, Sweden

Actively Recruiting

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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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