The Swedish BioFINDER - Preclinical AD Study
Launched by SKANE UNIVERSITY HOSPITAL · Nov 2, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The Swedish BioFINDER study is researching early signs of Alzheimer's disease (AD) to help identify it before symptoms appear. This study will take place at Skåne University Hospital in Sweden and aims to enroll up to 600 people aged 50 to 80 years. Most of the participants will be cognitively healthy individuals who may have early signs of Alzheimer’s. To participate, individuals aged 50-60 must have certain risk factors, such as a family history of dementia or specific brain changes detected by tests. Everyone will be assessed using simple cognitive tests and may choose to receive information about their risk for Alzheimer’s.
Participants can expect to be involved in the study for about four years, during which they will undergo various assessments, including memory tests and brain scans. It’s important to note that people with certain mental health conditions or significant cognitive issues are not eligible to participate. The findings from this study could help develop new ways to detect Alzheimer's early, potentially benefiting many people in the future.
Gender
ALL
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 APOE-E4 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 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 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).
About Skane University Hospital
Skåne University Hospital is a leading academic medical center located in Sweden, renowned for its commitment to advancing healthcare through innovative clinical research and trials. As a key player in the Nordic healthcare landscape, the hospital integrates cutting-edge medical practices with rigorous scientific inquiry, aiming to improve patient outcomes and foster advancements in medical knowledge. With a multidisciplinary approach, Skåne University Hospital collaborates with various stakeholders, including universities and research institutions, to conduct high-quality clinical trials that address critical health challenges and contribute to the development of new treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Malmö, , Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported