NCT03174938: BioFINDER2

The Swedish BioFINDER 2 Study

Recruiting now NA Last updated 1 April 2026

What this trial tests

NA trial testing Flutemetamol F18 Injection in Dementia in 2,950 participants. Currently enrolling.

Timeline

15 May 2017

Primary endpoint
1 December 2036

1 December 2036

Quick facts

Lead sponsor	Skane University Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	2,950
Start date	15 May 2017
Primary completion	1 December 2036
Estimated completion	1 December 2036
Sites	2 locations across Sweden

Drugs / interventions tested

• Flutemetamol F18 Injection
• [18F]-RO6958948
• Elecsys (Roche) Abeta42, Ttau and Ptau
• Lumipulse (Fujirebio) Abeta42, Ttau and Ptau

Conditions studied

• Dementia — all drugs for Dementia →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Parkinson Disease — all drugs for Parkinson Disease →
• Lewy Body Disease — all drugs for Lewy Body Disease →

Sponsor

Skane University Hospital

Who can join

Adults 20 to 100, any sex, with Dementia or Alzheimer Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Clinical diagnosis
  Time frame: Clinical diagnosis at last 1 day visit
  Clinical diagnosis according to consensus group decision blinded to the diagnostic test
• Clinical Dementia Rating-Sum of Boxes (CDR-SB)
  Time frame: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for approximately 2-8 years after baseline.
  Change in CDR-SB

Sponsor's own description

The Swedish BioFINDER 2 study is a new study that will launch in 2017 and extends the previous cohorts of BioFINDER 1 study (www.biofinder.se). BioFINDER 1 is used e.g. to characterize the role of beta-amyloid pathology in early diagnosis of Alzheimer's disease (AD) using amyloid-PET (18F-Flutemetamol) and Aβ analysis in cerebrospinal fluid samples. The BioFINDER 1 study has resulted in more than 40 publications during the last three years, many in high impact journals, and some the of the results have already had important implications for the diagnostic work-up patients with AD in the clinical routine practice.

The original BioFINDER 1 cohort started to include participants in 2008. Since then there has been a rapid development of biochemical and neuroimaging technologies which enable novel ways to the study biological processes involved in Alzheimer's disease in living people. There has also been a growing interest in the earliest stages of AD and other neurodegenerative diseases. With the advent of new tau-PET tracers there is now an opportunity to elucidate the role of tau pathology in the pathogenesis of AD and other tauopathies. The Swedish BioFINDER 2 study has been designed to complement the BioFINDER 1 study and to e.g. address issues regarding the role of tau pathology in different dementias and in preclinical stages of different dementia diseases. Further, the clinical assessments and MRI methods have been further optimized compared to BioFINDER 1. Detailed assessments of motor aspects and dual task performance, which is part of a sub-study named Motor-ACT: "Motor aspects and activities in relation to cognitive decline and brain pathologies, has been added to further optimize assessment of motor function.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Discriminative Accuracy of Plasma Phospho-tau217 for Alzheimer Disease vs Other Neurodegenerative Disorders.
   Palmqvist S, Janelidze S, Quiroz YT, Zetterberg H, et al · · 2020 · cited 1099× · PMID 32722745 · DOI 10.1001/jama.2020.12134
2. Plasma GFAP is an early marker of amyloid-β but not tau pathology in Alzheimer's disease.
   Pereira JB, Janelidze S, Smith R, Mattsson-Carlgren N, et al · · 2021 · cited 434× · PMID 34259835 · DOI 10.1093/brain/awab223
3. Head-to-Head Comparison of 8 Plasma Amyloid-β 42/40 Assays in Alzheimer Disease.
   Janelidze S, Teunissen CE, Zetterberg H, Allué JA, et al · · 2021 · cited 410× · PMID 34542571 · DOI 10.1001/jamaneurol.2021.3180
4. Highly accurate blood test for Alzheimer's disease is similar or superior to clinical cerebrospinal fluid tests.
   Barthélemy NR, Salvadó G, Schindler SE, He Y, et al · · 2024 · cited 359× · PMID 38382645 · DOI 10.1038/s41591-024-02869-z
5. Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Care.
   Palmqvist S, Tideman P, Mattsson-Carlgren N, Schindler SE, et al · · 2024 · cited 256× · PMID 39068545 · DOI 10.1001/jama.2024.13855
6. CSF MTBR-tau243 is a specific biomarker of tau tangle pathology in Alzheimer's disease.
   Horie K, Salvadó G, Barthélemy NR, Janelidze S, et al · · 2023 · cited 195× · PMID 37443334 · DOI 10.1038/s41591-023-02443-z
7. A two-step workflow based on plasma p-tau217 to screen for amyloid β positivity with further confirmatory testing only in uncertain cases.
   Brum WS, Cullen NC, Janelidze S, Ashton NJ, et al · · 2023 · cited 193× · PMID 37653254 · DOI 10.1038/s43587-023-00471-5
8. Confounding factors of Alzheimer's disease plasma biomarkers and their impact on clinical performance.
   Pichet Binette A, Janelidze S, Cullen N, Dage JL, et al · · 2023 · cited 188× · PMID 36152307 · DOI 10.1002/alz.12787