The Swedish BioFINDER - Preclinical AD Study

Last updated: April 23, 2025
Sponsor: Skane University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mild Cognitive Impairment

Alzheimer's Disease

Mental Disability

Treatment

Flutemetamol F18 Injection

Plasma Ab42/Ab40

MRI

Clinical Study ID

NCT06121544
SAIS
  • Ages 50-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 50-80

  2. Individuals aged 50-60 require at least one of the following risk factors for AD:

  3. Known APOE-E4 carrier

  4. Known 1st degree family history of dementia or severe memory loss with onsetprior to 75.

  5. Known amyloid brain pathology by either CSF or PET scan.

  6. Mini-Mental State Examination (MMSE) ≥26 (aged >65); MMSE ≥27 (aged 50-65).

  7. Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version.

  8. Speaks and understands Swedish to the extent that an interpreter is not necessary tofully understand the study information and cognitive tests.

6a. Preclinical AD subgroup (n=450): Amyloid pathology according to CSF AD biomarkers and Aβ-PET scans.

6b. Non-Preclinical AD subgroup (n=150): No sign of preclinical AD using CSF AD biomarkers or Aβ-PET scans.

Exclusion

Exclusion Criteria:

  1. Fulfils the criteria for minor or major neurocognitive disorder according to TheDiagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

  2. History of significant brain injury or other known neurologic disease or insult,resulting in lasting cognitive sequelae that would confound the assessment andstaging of potential neurodegenerative disease.

  3. Major depression, bipolar disorder, or recurrent psychotic disorders within the pastyear.

  4. History of alcohol and/or substance abuse or dependence within the past year.

  5. Significant unstable systemic illness or organ failure, such as terminal cancer,that makes it difficult to participate in the study.

  6. Refusing or unable to complete baseline cognitive and biomarker assessments (i.e.,cognitive testing, blood draw, MRI and PET).

Study Design

Total Participants: 800
Treatment Group(s): 6
Primary Treatment: Flutemetamol F18 Injection
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Skåne University Hospital

    Malmö,
    Sweden

    Active - Recruiting

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