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Recruiting

NCT Number: NCT06121544

The Swedish BioFINDER - Preclinical AD Study

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.

Recruiting

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Skåne University Hospital

Malmö, Sweden

Location status: Recruiting

Location contact

Erik Stomrud, MD, PhD

CONTACT

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50-80
  • Individuals aged 50-60 require at least one of the following risk factors for AD:
  • Known apolipoprotein E (APOE) -ε4 carrier
  • Known 1st degree family history of dementia or severe memory loss with onset prior to 75.
  • Known amyloid brain pathology by either CSF or PET scan.
  • Mini-Mental State Examination (MMSE) ≥26 (aged >65); MMSE ≥27 (aged 50-65).
  • Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version.
  • Speaks and understands Swedish to the extent that an interpreter is not necessary to fully understand the study information and cognitive tests.

6a. Preclinical Alzheimer's disease subgroup (n=450): Amyloid pathology according to cerebrospinal fluid Alzheimer's disease and amyloid PET scans.

6b. Non-Preclinical Alzheimer's disease subgroup (n=150): No sign of preclinical Alzheimer's disease using cerebrospinal fluid Alzheimer's disease biomarkers or Aβ-PET scans.

Exclusion criteria

  • Fulfils the criteria for minor or major neurocognitive disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
  • History of significant brain injury or other known neurologic disease or insult, resulting in lasting cognitive sequelae that would confound the assessment and staging of potential neurodegenerative disease.
  • Major depression, bipolar disorder, or recurrent psychotic disorders within the past year.
  • History of alcohol and/or substance abuse or dependence within the past year.
  • Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
  • Refusing or unable to complete baseline cognitive and biomarker assessments (i.e., cognitive testing, blood draw, MRI and PET).

Treatment and study plan

Plasma tau

Diagnostic Test

Plasma levels of different p-tau and np-tau species

Plasma β-Amyloid 42/40 (Aβ42/Aβ40)

Diagnostic Test

Plasma levels of Aβ42/Aβ40 ratio

Flutemetamol F18 Injection

Diagnostic Test

Positron emission tomography (PET) imaging of amyloid-β plaques

[18F]-RO6958948 Injection

Diagnostic Test

PET imaging of Tau aggregates

Magnetic Resonance Imaging (MRI)

Diagnostic Test

Different MRI sequences relevant for brain imaging

Primary outcomes

  1. Change in cognitive function

    Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.

    Rate of cognitive decline as measured by traditional cognitive and behavioral assessments including The Preclinical Alzheimer Cognitive Composite (PACC)

  2. Change in cognitive function - digital assessment

    Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.

    Rate of cognitive decline as measured by digital cognitive assessments

Secondary outcomes

  1. Rate of change in plasma biomarkers

    Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.

  2. Rate of change in cerebrospinal fluid biomarkers

    Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.

  3. Rate of change in amyloid PET

    Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.

  4. Rate of change in tau PET

    Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Erik Stomrud, MD, PhD

CONTACT

[email protected]

+46 40 33 10 00

Niklas Mattsson-Carlgren, MD, PhD

CONTACT

[email protected]

+46 40 33 10 00

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Lund University

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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