RecruitingNCT06121544

The Swedish BioFINDER - Preclinical AD Study


Sponsor

Skane University Hospital

Enrollment

800 participants

Start Date

Apr 1, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study, called the Swedish BioFINDER Preclinical AD Study, is tracking people who have early biological signs of Alzheimer's disease in the brain but have not yet developed significant memory problems. Researchers hope to understand how and when Alzheimer's develops before symptoms appear. **You may be eligible if...** - You are 50–80 years old - You have normal or near-normal memory and thinking - If you are 50–60, you must have at least one risk factor: carrying the APOE-E4 gene, a first-degree family member with early dementia, or prior evidence of amyloid plaques in the brain - You speak and understand Swedish without an interpreter **You may NOT be eligible if...** - You already have mild cognitive impairment or dementia - You have a significant brain injury or neurological disease - You have had major depression, bipolar disorder, or psychosis within the past year - You have had alcohol or substance dependence in the past year - You are unwilling or unable to complete brain scans (MRI, PET), blood tests, or cognitive assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPlasma tau

Plasma levels of different p-tau and np-tau species

DIAGNOSTIC_TESTPlasma β-Amyloid 42/40 (Aβ42/Aβ40)

Plasma levels of Aβ42/Aβ40 ratio

DIAGNOSTIC_TESTFlutemetamol F18 Injection

Positron emission tomography (PET) imaging of amyloid-β plaques

DIAGNOSTIC_TEST[18F]-RO6958948 Injection

PET imaging of Tau aggregates

DIAGNOSTIC_TESTMagnetic resonance imaging (MRI)

Different MRI sequences relevant for brain imaging


Locations(1)

Skåne University Hospital

Malmö, Sweden

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NCT06121544


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