NCT06121544 · RECRUITING
The Swedish BioFINDER - Preclinical AD Study
This Swedish observational study is tracking biomarkers in up to 600 cognitively healthy adults aged 50 to 80 to see whether blood tests and brain scans can detect early Alzheimer's changes before symptoms appear. Participants undergo plasma tests, amyloid and tau PET scans, and MRI over roughly four years. There is no drug or treatment involved. Because it is observational, it is about learning, not intervening.
Eligibility criteria
Inclusion Criteria: 1. Age 50-80 2. Individuals aged 50-60 require at least one of the following risk factors for AD: 1. Known apolipoprotein E (APOE) -ε4 carrier 2. Known 1st degree family history of dementia or severe memory loss with onset prior to 75. 3. Known amyloid brain pathology by either CSF or PET scan. 3. Mini-Mental State Examination (MMSE) ≥26 (aged >65); MMSE ≥27 (aged 50-65). 4. Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version. 5. 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: 1. Fulfils the criteria for minor or major neurocognitive disorder according to The Diagnostic 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 and staging of potential neurodegenerative disease. 3. Major depression, bipolar disorder, or recurrent psychotic disorders within the past year. 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).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-04-06