World Alzheimer's Month - Supporting development of medicines by qualification of biomarkers
The European Medicines Agency supports World Alzheimer's Month, which is taking place throughout September 2013 and culminates in World Alzheimer's Day on Saturday 21 September.
Alzheimer’s disease is the most common cause of dementia in the elderly, affecting more than 5 million people in the European Union. It destroys brain cells and nerves, disrupting the transmitters which carry messages in the brain, particularly those responsible for storing memories.
The Alzheimer's medicines available today only treat the symptoms of the disease. However, a number of therapies targeting the mechanism of the disease, such as the production and clearance of beta amyloid, are under development. These medicines (called disease-modifying agents) are intended to target the early stages of the disease and have the potential to alter its long-term course.
One of the most active areas in medicine development for Alzheimer’s disease is the development and validation of methodologies and biomarkers that allow the disease to be diagnosed before patients show signs of dementia and help with the selection of patients for clinical evaluation.
Four qualification opinions on novel methodologies adopted by the CHMP
The Agency helps companies in their research and development of new medicines by issuing opinions on the acceptability of using a methodology in a specific way, such as an imaging method or a biomarker.
Since 2011, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted four of these qualification opinions for use in the development of medicines for Alzheimer’s disease. Three of these qualification opinions are for biomarkers to help identify and select patients at the pre-dementia stage of the disease. The fourth one is for a biomarker to be used to select patients for clinical trials in mild and moderate Alzheimer’s disease.
In August 2013, a public consultation ended on a qualification opinion for a novel model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease. The simulation tool is intended to provide a quantitative rationale for the selection of study design and inclusion criteria for the recruitment of patients.
In the diagnostic area, the first radiopharmaceutical for positron-emission-tomography (PET) imaging of beta amyloid neuritic plaques in the brain (Amyvid) was approved by the European Commission in January 2013 on the recommendation of the CHMP. This diagnostic agent can be used in patients who are being evaluated for Alzheimer’s disease and other causes of cognitive decline; it is to be used in conjunction with a clinical evaluation to reduce the frequency of false-positive diagnoses of Alzheimer’s disease. Two other diagnostic radiopharmaceuticals for Alzheimer’s disease (florbetaben (18F) and flutemetamol (18F)) are currently under evaluation by the CHMP.
By the end of 2013, the Agency will decide whether or not there is a need to revise the guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias on the basis of new knowledge obtained from the use of biomarkers in clinical evaluation and new trends in research and development.
About World Alzheimer's Month
World Alzheimer's Month is dedicated to raising awareness of dementia and challenging stigma. It is organised by the Alzheimer’s disease International. The theme in 2013 is 'dementia: a journey of caring'.
- World Alzheimer's Month
- Qualification of novel methodologies for medicine development
- European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging of β-amyloid neuritic plaque density (19/10/2012)
- Guideline on medicinal products for the treatment of Alzheimer's disease and other dementias (24/07/2008)
- Concept paper on no need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias (26/03/2012)
- Draft qualification opinion of a novel data-driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease (19/07/2013)