NCT06121544 The Swedish BioFINDER - Preclinical AD Study
| NCT ID | NCT06121544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Skane University Hospital |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2022-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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).
Contact & Investigator
Erik Stomrud, MD, PhD
PRINCIPAL INVESTIGATOR
Skane University Hospital and Lund University
Frequently Asked Questions
Who can join the NCT06121544 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06121544 currently recruiting?
Yes, NCT06121544 is actively recruiting participants. Contact the research team at erik.stomrud@med.lu.se for enrollment information.
Where is the NCT06121544 trial being conducted?
This trial is being conducted at Malmö, Sweden.
Who is sponsoring the NCT06121544 clinical trial?
NCT06121544 is sponsored by Skane University Hospital. The principal investigator is Erik Stomrud, MD, PhD at Skane University Hospital and Lund University. The trial plans to enroll 800 participants.
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