The Pathologist
  • Explore Pathology

    Explore

    • Latest
    • Insights
    • Case Studies
    • Opinion & Personal Narratives
    • Research & Innovations
    • Product Profiles

    Featured Topics

    • Molecular Pathology
    • Infectious Disease
    • Digital Pathology

    Issues

    • Latest Issue
    • Archive
  • Subspecialties
    • Oncology
    • Histology
    • Cytology
    • Hematology
    • Endocrinology
    • Neurology
    • Microbiology & Immunology
    • Forensics
    • Pathologists' Assistants
  • Training & Education

    Career Development

    • Professional Development
    • Career Pathways
    • Workforce Trends

    Educational Resources

    • Guidelines & Recommendations
    • App Notes
    • eBooks

    Events

    • Webinars
    • Live Events
  • Events
    • Live Events
    • Webinars
  • Profiles & Community

    People & Profiles

    • Power List
    • Voices in the Community
    • Authors & Contributors
  • Multimedia
    • Video
    • Pathology Captures
Subscribe
Subscribe

False

The Pathologist / Issues / 2018 / Sep / Better Biomarkers for AD R&D
Neurology Clinical care Microscopy and imaging Laboratory management Precision medicine Neurology Screening and monitoring

Better Biomarkers for AD R&D

Priming diagnostics for the future of Alzheimer’s disease research and treatment

By Carlo Medici 09/13/2018 1 min read
  • Full Article
  • Summary
  • Takeaways

Share

Objective:

To highlight the need for valid biomarkers in Alzheimer’s disease (AD) for early detection, patient stratification, and monitoring treatment success.

Approach:
  • Current Challenges: Drug development for AD has faced significant challenges, with clinical trials often failing due to late intervention when symptoms manifest.
  • Importance of Biomarkers: Valid biomarkers are essential for detecting pre-symptomatic AD, stratifying patients, and monitoring treatment efficacy.
  • FDA Guidelines: The FDA has proposed a biomarker-based approach to guide drug development, allowing for approval based on surrogate biomarker measurements.
  • Types of Biomarkers: Three general groups of biomarkers are recognized: beta-amyloid plaques, pathologic tau proteins, and neuronal degeneration markers.
Key Findings:
  • Current drug development for Alzheimer's disease has not been successful, necessitating earlier intervention.
  • Biomarkers are critical for identifying and treating Alzheimer's disease before symptoms appear.
  • The FDA is open to a biomarker-driven approach for drug approval in Alzheimer's disease.
Interpretation:

Limitations:
  • Clinical diagnosis of Alzheimer's disease is often not sensitive or specific.
  • Many potential biomarkers are still under study and not yet available for clinical use.
Conclusion:

A focus on biomarkers, particularly beta-amyloid and tau, is essential for advancing Alzheimer's disease research and treatment.

Sources:
  • FDA Draft Guidelines
  • National Institute on Aging and Alzheimer’s Association

This content is an AI-generated, fully rewritten summary based on a published scholarly article. It does not reproduce the original text and is not a substitute for the original publication. Readers are encouraged to consult the source for full context, data, and methodology.

Newsletters

Receive the latest pathologist news, personalities, education, and career development – weekly to your inbox.

Newsletter Signup Image

References

  1. US Food and Drug Administration, “Early Alzheimer’s Disease: Developing Drugs for Treatment” (2018). Available at: https://bit.ly/2o96fnl. Accessed August 17, 2018. T Jonsson et al., “A mutation in APP protects against Alzheimer’s disease and age-related cognitive decline”, Nature, 488, 96–99 (2012). PMID: 22801501. H Martiskainen et al., “Decreased plasma β-amyloid in the Alzheimer’s disease APP A673T variant carriers”, Ann Neurol, 82, 128–132 (2017). PMID: 28556232. CR Jack Jr et al., “NIA-AA Research Framework: Toward a biological definition of Alzheimer’s disease”, Alzheimers Dement, 14, 535–562 (2018). PMID: 29653606. ER Fantoni et al., “A systematic review and aggregated analysis on the impact of amyloid PET brain imaging on the diagnosis, diagnostic confidence, and management of patients being evaluated for Alzheimer’s disease”, J Alzheimers Dis, 63, 783–796 (2018). PMID: 29689725. R Ossenkoppele et al., “Impact of molecular imaging on the diagnostic process in a memory clinic”, Alzheimers Dement, 9, 414–421 (2013). PMID: 23164552. P Sánchez-Juan et al., “Practical utility of amyloid and FDG-PET in an academic dementia center”, Neurology, 82, 230–238 (2014). PMID: 24353340. M Grundman et al., “Potential impact of amyloid imaging on diagnosis and intended management in patients with progressive cognitive decline”, Alzheimer Dis Assoc Disord, 27, 4–15 (2013). PMID: 23203162. AS Zannas et al., “Impact of ¹⁸F-florbetapir PET imaging of β-amyloid neuritic plaque density on clinical decision-making”, Neurocase, 20, 466–473 (2014). PMID: 23672654. EM Mitsis et al., “A consecutive case series experience with [18 F] florbetapir PET imaging in an urban dementia center: impact on quality of life, decision making, and disposition”, Mol Neurodegener, 9, 10 (2014). PMID: 24484858. iDEAS, “Imaging Dementia – Evidence for Amyloid Scanning” (2018). Available at: https://www.ideas-study.org. Accessed August 17, 2018. A Nakamura et al., “High performance plasma amyloid-β biomarkers for Alzheimer’s disease”, Nature, 554, 249–254 (2018). PMID: 29420472. A Nabers et al., “Amyloid blood biomarker detects Alzheimer’s disease”, EMBO Mol Med, 10, e8763 (2018). PMID: 29626112. N Mattsson et al., “Association of plasma neurofilament light with neurodegeneration in patients with Alzheimer disease”, JAMA Neurol, 74, 557–566 (2017). PMID: 28346578.

About the Author(s)

Carlo Medici

Carlo Medici is chief executive officer of Alzeca Biosciences, Houston, USA, a company developing novel advanced imaging agents for the early diagnosis of neurodegenerative diseases, including Alzheimer’s disease.

More Articles by Carlo Medici

Explore More in Pathology

Dive deeper into the world of pathology. Explore the latest articles, case studies, expert insights, and groundbreaking research.

False

Advertisement

Recommended

False

Affiliations:

Specialties:

Areas of Expertise:

Contributions:

False

The Pathologist
Subscribe

About

  • About Us
  • Work at Conexiant Europe
  • Terms and Conditions
  • Privacy Policy
  • Advertise With Us
  • Contact Us

Copyright © 2026 Texere Publishing Limited (trading as Conexiant), with registered number 08113419 whose registered office is at Booths No. 1, Booths Park, Chelford Road, Knutsford, England, WA16 8GS.