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Drug Development.

Howard H Feldman1,2, Nicolas Villain3,4, Giovanni B Frisoni5,6

  • 1Alzheimer's Disease Cooperative Study, University of California San Diego, La Jolla, CA, USA.

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Summary
This summary is machine-generated.

Biomarkers for Alzheimer's pathology (BAP) aid risk stratification in asymptomatic individuals. Diagnosis requires clinical expression, not BAP alone, enabling tailored patient journeys and management.

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Area of Science:

  • Neurology
  • Biomarker Research
  • Geriatric Medicine

Background:

  • Biomarkers of Alzheimer's pathology (BAP) enable new diagnostic considerations for at-risk, asymptomatic individuals.
  • International Working Group (IWG) updated recommendations emphasize a patient-centered approach, integrating clinical evaluation with risk factors, biomarkers, and genetics.
  • Risk stratification and tailored patient journeys are key components of the updated IWG guidelines.

Purpose of the Study:

  • To review and update recommendations for diagnosing and managing individuals at risk for Alzheimer's disease (AD) based on biomarkers.
  • To establish a risk stratification framework for cognitively unimpaired individuals with BAP.
  • To guide clinical management and research priorities for different risk groups.

Main Methods:

  • An evidence review of literature published between July 2020 and March 2024 was conducted.
  • The review focused on various biomarker search terms related to Alzheimer's disease (AD) and cognitively unimpaired individuals.
  • Papers examining near-term and lifetime risks of AD dementia progression in relation to BAP patterns were analyzed.

Main Results:

  • A risk stratification framework was developed, classifying individuals as "Asymptomatic At-Risk" or "Presymptomatic".
  • Most cognitively unimpaired individuals with BAP, including amyloid positivity, will not develop clinical AD.
  • The "Presymptomatic" group includes those with genetic mutations, Down syndrome, or specific tau PET biomarker patterns indicating a high likelihood of clinical AD expression.

Conclusions:

  • Diagnosis of Alzheimer's disease (AD) should not be based solely on biomarkers without clinical expression.
  • The IWG risk stratification classification supports tailored management approaches and individualized patient journeys.
  • Urgent prioritization of preventive disease-modifying treatments is recommended for the "Presymptomatic" group.