NCT06121544Recruiting
The Swedish BioFINDER - Preclinical AD Study
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 2 Nov 2023
- Start date
- 1 Apr 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Skane University Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT06121544
What you commit to
- Study type: Observational
- Planned participants: 800
- From 1 Apr 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Refusing or unable to complete baseline cognitive and biomarker assessments (i.e., cognitive testing, blood draw, MRI and PET).
Who the study is looking for
- Age 50-80
- Individuals aged 50-60 require at least one of the following risk factors for AD:
- 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.
- 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 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.
Age in the registry: 50 years to 80 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.