Biochemical Markers in Alzheimer's Disease Clinical Trials

Abstract

This article summarizes how biochemical markers may aid in the development of novel treatments that interfere with fundamental pathogenic processes in Alzheimer's disease. Details are given on the potential use of biomarkers in Alzheimer's disease clinical trials as additional inclusion criteria to enrich study populations with participants who really suffer from the disease, as a means to stratify study participants into meaningful subgroups that may benefit differently from the treatment, and as tools to detect desired biochemical effects and undesired side effects of the drug.

KEYWORDS::

• Alzheimer's disease
• amyloid
• biomarkers
• cerebrospinal fluid
• clinical trials
• plasma
• tau

Financial & competing interests disclosure

Work in the authors’ laboratories is supported by the Royal Swedish Academy of Sciences (H Zetterberg), the Swedish Research Council (H Zetterberg and K Blennow), Alzheimer's Association (H Zetterberg and K Blennow) and NIH (U01-AG024904, M Shaw). H Zetterberg has served on a scientific advisory board for GSK. K Blennow is a consultant for AstraZeneca, and has served on scientific advisory boards for AdLyfe Corporation, Bayer Schering Pharma AG, Bristol-Myers Squibb, Ely Lilly, Merz Pharmaceuticals and Wyeth Research. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

Work in the authors’ laboratories is supported by the Royal Swedish Academy of Sciences (H Zetterberg), the Swedish Research Council (H Zetterberg and K Blennow), Alzheimer's Association (H Zetterberg and K Blennow) and NIH (U01-AG024904, M Shaw). H Zetterberg has served on a scientific advisory board for GSK. K Blennow is a consultant for AstraZeneca, and has served on scientific advisory boards for AdLyfe Corporation, Bayer Schering Pharma AG, Bristol-Myers Squibb, Ely Lilly, Merz Pharmaceuticals and Wyeth Research. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.