The Swedish BioFINDER - Preclinical AD Study
1 other identifier
observational
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 27, 2025
April 1, 2025
4.8 years
November 2, 2023
April 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in cognitive function
Rate of cognitive decline as measured by traditional cognitive and behavioral assessments including The Preclinical Alzheimer Cognitive Composite (PACC)
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Change in cognitive function - digital assessment
Rate of cognitive decline as measured by digital cognitive assessments
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Secondary Outcomes (4)
Rate of change in plasma biomarkers
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of change in CSF biomarkers
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Rate of change in amyloid PET
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Rate of change in tau PET
Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Study Arms (2)
Cognitively unimpaired individuals with preclinical Alzheimer's disease
75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
Cognitively unimpaired individuals without preclinical Alzheimer's disease.
25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
Interventions
Plasma levels of different p-tau and np-tau species
Plasma levels of Ab42/Ab40 ratio
Positron emission tomography (PET) imaging of amyloid-β plaques
PET imaging of Tau aggregates
Different MRI sequences relevant for brain imaging
Eligibility Criteria
Cognitively unimpaired individuals (50-80 y) Step 1. Cognitively normal individuals will be screened using plasma p-tau217 (Eli Lilly-developed MSD method). Step 2. CSF AD biomarkers will be done in a subpopulation including all plasma p-tau217 positive individuals and randomly selected individuals with normal p-tau217 (matching 9:1). Step 3. Amyloid PET imaging. 450 individuals with positive AD biomarkers and 150 with normal AD biomarkers will be enrolled into longitudinal study. FOLLOW-UP FOR 4 YEARS: Cognitive testing and blood draws will be conducted at baseline and 12, 24, 36 and 48 months. CSF collection, MRI, amyloid PET and tau PET will be conducted at baseline, and 24 and 48 months.
You may qualify if:
- Age 50-80
- Individuals aged 50-60 require at least one of the following risk factors for AD:
- Known APOE-E4 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.
- a. Preclinical AD subgroup (n=450): Amyloid pathology according to CSF AD biomarkers and Aβ-PET scans.
- b. Non-Preclinical AD subgroup (n=150): No sign of preclinical AD using CSF AD biomarkers or Aβ-PET scans.
You may not qualify if:
- 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.
- Refusing or unable to complete baseline cognitive and biomarker assessments (i.e., cognitive testing, blood draw, MRI and PET).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Skane University Hospitallead
- Lund Universitycollaborator
Study Sites (1)
Skåne University Hospital
Malmo, Sweden
Biospecimen
Whole blood, plasma, cerebrospinal fluid (CSF)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., PhD
Study Record Dates
First Submitted
November 2, 2023
First Posted
November 8, 2023
Study Start
April 1, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Within one year after study completion