NCT06120361: ADetect

The Swedish BioFINDER - Primary Care Study

Recruiting now Last updated 6 April 2026

What this trial tests

trial testing Plasma APS 2 score in Mild Dementia in 1,200 participants. Currently enrolling.

Timeline

1 January 2020

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	Skane University Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,200
Start date	1 January 2020
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across Sweden

Drugs / interventions tested

• Plasma APS 2 score
• Plasma p-tau217/np-tau217
• Plasma p-tau217
• Plasma neurofilament light (NfL)
• Plasma Ab42/Ab40
• MRI and CT of the brain
• Different cognitive tests

Conditions studied

• Mild Dementia — all drugs for Mild Dementia →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• SCD — all drugs for SCD →
• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Skane University Hospital

Who can join

40 and older, any sex, with Mild Dementia or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall aim of the study is to improve the diagnostic accuracy of AD and cognitive impairment in primary care settings to ensure better care and treatment as well as facilitate correct referrals to specialized memory clinics. The investigators will strive to recruit diverse and representative populations of patients with subjective cognitive decline (SCD), mild cognitive impairment (MCI) and mild dementia. The specific aims of the study are to:

1. Improve the detection of mild cognitive impairment (MCI) and dementia in primary care.
2. Develop and evaluate cognitive tests, blood-based biomarkers and brain imaging methods that are suitable for accurate and early diagnosis of Alzheimer's disease (AD) in primary care.
3. To prospectively validate plasma AD biomarkers for diagnosis of patients with cognitive symptoms who are evaluated in primary care.
4. Determine whether blood AD biomarkers improve patient management in primary care.

Publications & conference data

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

1. 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
2. Plasma phospho-tau217 for Alzheimer's disease diagnosis in primary and secondary care using a fully automated platform.
   Palmqvist S, Warmenhoven N, Anastasi F, Pilotto A, et al · · 2025 · cited 98× · PMID 40205199 · DOI 10.1038/s41591-025-03622-w
3. Primary care detection of Alzheimer's disease using a self-administered digital cognitive test and blood biomarkers.
   Tideman P, Karlsson L, Strandberg O, Calling S, et al · · 2025 · cited 10× · PMID 40954312 · DOI 10.1038/s41591-025-03965-4
4. Individualized, cross-validated prediction of future dementia using cognitive assessments in people with mild cognitive symptoms.
   Borland E, Mattson-Carlgren N, Tideman P, Alzheimer's Disease Neuroimaging Initiative, et al · · 2024 · cited 4× · PMID 39417379 · DOI 10.1002/alz.14305
5. A minimally invasive dried blood spot biomarker test for the detection of Alzheimer's disease pathology.
   Huber H, Montoliu-Gaya L, Brum WS, Vávra J, et al · · 2026 · cited 1× · PMID 41491101 · DOI 10.1038/s41591-025-04080-0
6. Speech-based digital cognitive assessment for clinical trials: Detecting cognitive impairment stages and AD biomarker relations across European cohorts.
   König A, Tröger J, Mallick E, Linz N, et al · · 2026 · PMID 42151661 · DOI 10.1002/alz.71462
7. Clinical staging in Swedish primary care using the Amsterdam Instrumental Activities of Daily Living Questionnaire.
   Fawad A, van der Landen SM, Tideman P, van der Putten-Toorenburg A, et al · · 2026 · PMID 42040886 · DOI 10.1002/dad2.70344
8. Eligibility for amyloid targeting therapies among primary care patients with cognitive symptoms.
   Borgström Bolmsjö B, Barbosa Djärf J, van Westen D, Schindler SE, et al · · 2026 · PMID 41865008 · DOI 10.1186/s13195-026-02019-2