Alzheimer DiseaseNCT06121544
The Swedish BioFINDER - Preclinical AD Study
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Skane University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia
- What is being tested?
- Plasma tau, Plasma β-Amyloid 42/40 (Aβ42/Aβ40) and Flutemetamol F18 Injection
- Type of treatment
- Injection or infusion
- How many people
- 800 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Adult, Older adult
Study population: Cognitively unimpaired individuals (50-80 years old) Step 1. Cognitively normal individuals will be screened using plasma p-tau217 (Eli Lilly-developed Meso Scale Discovery method). Step 2. Cerebrospinal fluid Alzheimer's disease biomarkers analysis 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 Alzheimer's disease biomarkers and 150 with normal Alzheimer's disease 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. cerebrospinal fluid collection, MRI, amyloid PET and tau PET will be conducted at baseline, and 24 and 48 months.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Malmö
Erik Stomrud, MD, PhD
About this study
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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia
- Being tested
- Plasma tau, Plasma β-Amyloid 42/40 (Aβ42/Aβ40), Flutemetamol F18 Injection, [18F]-RO6958948 Injection, Magnetic resonance imaging (MRI)
- Keywords
- Preclinical Alzheimer, early diagnosis, biomarkers, plasma, CSF, PET
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma tauDiagnostic test
Plasma levels of different p-tau and np-tau species
Plasma β-Amyloid 42/40 (Aβ42/Aβ40)Diagnostic test
Plasma levels of Aβ42/Aβ40 ratio
Flutemetamol F18 InjectionDiagnostic test
Positron emission tomography (PET) imaging of amyloid-β plaques
[18F]-RO6958948 InjectionDiagnostic test
PET imaging of Tau aggregates
Magnetic resonance imaging (MRI)Diagnostic test
Different MRI sequences relevant for brain imaging
| Study group | Role | What they receive |
|---|---|---|
| Cognitively unimpaired individuals with preclinical Alzheimer's disease | 75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease. Receives: Diagnostic Test: Plasma tau; Diagnostic Test: Plasma β-Amyloid 42/40 (Aβ42/Aβ40); Diagnostic Test: Flutemetamol F18 Injection; Diagnostic Test: [18F]-RO6958948 Injection; Diagnostic Test: Magnetic resonance imaging (MRI) | |
| Cognitively unimpaired individuals without preclinical Alzheimer's disease. | 25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease. Receives: Diagnostic Test: Plasma tau; Diagnostic Test: Plasma β-Amyloid 42/40 (Aβ42/Aβ40); Diagnostic Test: Flutemetamol F18 Injection; Diagnostic Test: [18F]-RO6958948 Injection; Diagnostic Test: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
Rate of cognitive decline as measured by traditional cognitive and behavioral assessments including The Preclinical Alzheimer Cognitive Composite (PACC)
Measured: 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
Measured: 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
Measured: 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 cerebrospinal fluid biomarkers
Measured: 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
Measured: 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
Measured: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Erik Stomrud, Skane University Hospital
- Investigators
- Erik Stomrud, MD, PhD, Principal investigator, Skane University Hospital and Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121544
- Sponsor's protocol ID
- SAIS
- Status last verified
- Apr 2026
- First submitted
- 2 Nov 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Swedish BioFINDER - Preclinical AD Study
- ClinicalTrials.gov ID
- NCT06121544
- Acronym / sponsor ID
- SAIS
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia
- Keywords
- Preclinical Alzheimer, early diagnosis, biomarkers, plasma, CSF, PET
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitively unimpaired individuals with preclinical Alzheimer's disease | – | Diagnostic Test: Plasma tau, Diagnostic Test: Plasma β-Amyloid 42/40 (Aβ42/Aβ40), Diagnostic Test: Flutemetamol F18 Injection, Diagnostic Test: [18F]-RO6958948 Injection, Diagnostic Test: Magnetic resonance imaging (MRI)75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease. |
| Cognitively unimpaired individuals without preclinical Alzheimer's disease. | – | Diagnostic Test: Plasma tau, Diagnostic Test: Plasma β-Amyloid 42/40 (Aβ42/Aβ40), Diagnostic Test: Flutemetamol F18 Injection, Diagnostic Test: [18F]-RO6958948 Injection, Diagnostic Test: Magnetic resonance imaging (MRI)25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cognitively unimpaired individuals (50-80 years old) Step 1. Cognitively normal individuals will be screened using plasma p-tau217 (Eli Lilly-developed Meso Scale Discovery method). Step 2. Cerebrospinal fluid Alzheimer's disease biomarkers analysis 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 Alzheimer's disease biomarkers and 150 with normal Alzheimer's disease 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. cerebrospinal fluid collection, MRI, amyloid PET and tau PET will be conducted at baseline, and 24 and 48 months.
Key inclusion criteria (10 listed)
- Age 50-80
- Individuals aged 50-60 require at least one of the following risk factors for AD:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma tauPlasma levels of different p-tau and np-tau species | Diagnostic test | Cognitively unimpaired individuals with preclinical Alzheimer's disease, Cognitively unimpaired individuals without preclinical Alzheimer's disease. |
| Plasma β-Amyloid 42/40 (Aβ42/Aβ40)Plasma levels of Aβ42/Aβ40 ratio | Diagnostic test | Cognitively unimpaired individuals with preclinical Alzheimer's disease, Cognitively unimpaired individuals without preclinical Alzheimer's disease. |
| Flutemetamol F18 InjectionPositron emission tomography (PET) imaging of amyloid-β plaques | Diagnostic test | Cognitively unimpaired individuals with preclinical Alzheimer's disease, Cognitively unimpaired individuals without preclinical Alzheimer's disease. |
| [18F]-RO6958948 InjectionPET imaging of Tau aggregates | Diagnostic test | Cognitively unimpaired individuals with preclinical Alzheimer's disease, Cognitively unimpaired individuals without preclinical Alzheimer's disease. |
| Magnetic resonance imaging (MRI)Different MRI sequences relevant for brain imaging | Diagnostic test | Cognitively unimpaired individuals with preclinical Alzheimer's disease, Cognitively unimpaired individuals without preclinical Alzheimer's disease. |
Primary outcome
Change in cognitive function
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of cognitive decline as measured by traditional cognitive and behavioral assessments including The Preclinical Alzheimer Cognitive Composite (PACC)
Change in cognitive function - digital assessment
Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of cognitive decline as measured by digital cognitive assessments
4 secondary outcomes
Rate of change in plasma biomarkers
Time frame: 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 cerebrospinal fluid biomarkers
Time frame: 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 frame: 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 frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- The official webpage of the Swedish BioFINDER StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erik Stomrud, MD, PhD principal investigator
Skane University Hospital and Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Skane University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik Stomrud, MD, PhD (+46 40 33 10 00, erik.stomrud@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function (time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.