Status:
RECRUITING
The Swedish BioFINDER - Preclinical AD Study
Lead Sponsor:
Skane University Hospital
Collaborating Sponsors:
Lund University
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
50-80 years
Brief 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 ta...
Eligibility Criteria
Inclusion
- Age 50-80
- Individuals aged 50-60 require at least one of the following risk factors for AD:
- Known APOE-E4 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 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
- 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).
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06121544
Start Date
April 1 2022
End Date
December 31 2026
Last Update
April 27 2025
Active Locations (1)
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1
Skåne University Hospital
Malmo, Sweden