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Recruiting NCT06121544

The Swedish BioFINDER - Preclinical AD Study

— Observational Alzheimer Disease Mild Cognitive Impairment Mild Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma tau, Plasma β-Amyloid 42/40 (Aβ42/Aβ40), Flutemetamol F18 Injection, [18F]-RO6958948 Injection.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test Plasma tau
    Plasma levels of different p-tau and np-tau species
  • Diagnostic test Plasma β-Amyloid 42/40 (Aβ42/Aβ40)
    Plasma levels of Aβ42/Aβ40 ratio
  • Diagnostic test Flutemetamol F18 Injection
    Positron emission tomography (PET) imaging of amyloid-β plaques
  • Diagnostic test [18F]-RO6958948 Injection
    PET imaging of Tau aggregates
  • Diagnostic test Magnetic resonance imaging (MRI)
    Different MRI sequences relevant for brain imaging

Primary outcome measures

  • 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.]
  • 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.]
Secondary outcome measures (4)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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).
  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Skåne University Hospital — Malmö

Identifiers

NCT: NCT06121544 · SAIS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗