Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives.

• Advances in therapeutic strategies for Alzheimer's disease that lead to even small delays in onset and progression of the condition would significantly reduce the global burden of the disease. To effectively test compounds for Alzheimer's disease and bring therapy to individuals as early as possible there is an urgent need for collaboration between academic institutions, industry and regulatory organizations for the establishment of standards and networks for the identification and qualification of biological marker candidates. Biomarkers are needed to monitor drug safety, to identify individuals who are most likely to respond to specific treatments, to stratify presymptomatic patients and to quantify the benefits of treatments. Biomarkers that achieve these characteristics should enable objective business decisions in portfolio management and facilitate regulatory approval of new therapies.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Psykiatri (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Psychiatry (hsv//eng)

Keyword

Alzheimer Disease

diagnosis

genetics

Animals

Biological Markers

Clinical Trials as Topic

Drug Discovery

legislation & jurisprudence

trends

Drug Industry

trends

Endpoint Determination

Humans

Magnetic Resonance Imaging

Molecular Biology

Positron-Emission Tomography

Risk Assessment

Publication and Content Type

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