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Alzheimers Dement (Amst). 2015 Oct 03;1(4):412-9. doi: 10.1016/j.dadm.2015.09.001. eCollection 2015 Dec.

Revolutionizing Alzheimer's disease and clinical trials through biomarkers.

Alzheimer's & dementia (Amsterdam, Netherlands)

Niklas Mattsson, Maria C Carrillo, Robert A Dean, Michael D Devous, Tania Nikolcheva, Pedro Pesini, Hugh Salter, William Z Potter, Reisa S Sperling, Randall J Bateman, Lisa J Bain, Enchi Liu

Affiliations

  1. Clinical Memory Research Unit, Lund University, Sweden.
  2. Alzheimer's Association, Chicago, IL, USA.
  3. Eli Lilly & Co, Inc., Indianapolis, IN, USA.
  4. Avid Radiopharmaceuticals, Philadelphia, PA, USA.
  5. F. Hoffmann-La Roche, Basel, Switzerland.
  6. Araclon Grifols, Zaragoza, Spain.
  7. AztraZeneca, Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institutet, Sweden.
  8. Foundation for the NIH, Bethesda, MD, USA.
  9. Brigham and Women's Hospital, Boston, MA, USA.
  10. Washington University School of Medicine, St. Louis, MO, USA.
  11. Elverson, PA, USA.
  12. Janssen Research and Development, LLC., San Diego, CA, USA.

PMID: 27239522 PMCID: PMC4879481 DOI: 10.1016/j.dadm.2015.09.001

Abstract

The Alzheimer's Association's Research Roundtable met in May 2014 to explore recent progress in developing biomarkers to improve understanding of disease pathogenesis and expedite drug development. Although existing biomarkers have proved extremely useful for enrichment of subjects in clinical trials, there is a clear need to develop novel biomarkers that are minimally invasive and that more broadly characterize underlying pathogenic mechanisms, including neurodegeneration, neuroinflammation, and synaptic dysfunction. These may include blood-based assays and new neuropsychological testing protocols, as well as novel ligands for positron emission tomography imaging, and advanced magnetic resonance imaging methodologies. In addition, there is a need for biomarkers that can serve as theragnostic markers of response to treatment. Standardization remains a challenge, although international consortia have made substantial progress in this area and provide lessons for future standardization efforts.

Keywords: Alzheimer's disease; Amyloid; Biomarkers; Blood biomarkers; CSF; Cerebrospinal fluid; Clinical trials; Imaging; MRI; PET; Tau

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