Examining early biomarkers for Alzheimer's disease

The Swedish BioFINDER - Preclinical AD Study

This study is trying to find early signs of Alzheimer's disease in healthy people aged 50 to 80 to help catch the disease sooner.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Skane University Hospital (Academic / other)
• Locations: 1 site (Malmö)
• Trial ID: NCT06121544 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate biomarkers associated with Alzheimer's disease (AD) in cognitively healthy individuals aged 50 to 80 years, with a focus on early diagnosis. Conducted at Skåne University Hospital in Sweden, the study will enroll up to 600 participants, with a significant portion expected to have preclinical AD. Participants will undergo various assessments, including plasma and CSF analysis, PET scans, and MRI, over a participation period of approximately four years. The study seeks to identify potential screening tools for the general population to detect AD risk early.

Who should consider this trial

Good fit: Ideal candidates are cognitively healthy individuals aged 50 to 80, particularly those with risk factors for Alzheimer's disease.

Not a fit: Patients who already exhibit symptoms of neurocognitive disorders or have a confirmed diagnosis of Alzheimer's disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and intervention strategies for Alzheimer's disease.

How similar studies have performed: Other studies have shown promise in using biomarkers for early detection of Alzheimer's disease, indicating a growing interest and potential in this area.

Eligibility criteria

Inclusion Criteria:

1. Age 50-80
2. Individuals aged 50-60 require at least one of the following risk factors for AD:

   1. Known apolipoprotein E (APOE) -ε4 carrier
   2. Known 1st degree family history of dementia or severe memory loss with onset prior to 75.
   3. Known amyloid brain pathology by either CSF or PET scan.
3. Mini-Mental State Examination (MMSE) ≥26 (aged \>65); MMSE ≥27 (aged 50-65).
4. Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version.
5. 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:

1. Fulfils the criteria for minor or major neurocognitive disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
2. 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.
3. Major depression, bipolar disorder, or recurrent psychotic disorders within the past year.
4. History of alcohol and/or substance abuse or dependence within the past year.
5. Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
6. Refusing or unable to complete baseline cognitive and biomarker assessments (i.e., cognitive testing, blood draw, MRI and PET).

Where this trial is running

Malmö

• Skåne University Hospital — Malmö, Sweden (Recruiting)

Study contacts

• Principal investigator: Erik Stomrud, MD, PhD — Skane University Hospital and Lund University
• Study coordinator: Erik Stomrud, MD, PhD

Conditions Alzheimer Disease; Mild Cognitive Impairment; Mild Dementia; Preclinical Alzheimer, early diagnosis, biomarkers, plasma, CSF, PET