The Swedish BioFINDER - Preclinical AD Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorSkane University Hospital
About this trial
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
Qualifiers
Age 50-80
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Plasma tau
- Plasma β-Amyloid 42/40 (Aβ42/Aβ40)
- Flutemetamol F18 Injection
- [18F]-RO6958948 Injection
- Magnetic resonance imaging (MRI)
Treatment groups
800 Participants
are divided into 2 treatment groupsSponsors and collaborators
Skane University Hospital
Lead sponsor
Lund University
Collaborator
Source ClinicalTrials.gov