European Medicines Agency releases qualification opinion on diagnosis of pre-dementia Alzheimer's for public consultation
The European Medicines Agency is seeking opinions from the public on a qualification opinion describing a biomarker to help identify patients who can be recruited for clinical trials of treatments for early Alzheimer's disease.
The draft opinion states that patients with a low hippocampus volume detected with a magnetic resonance imaging (MRI) scan, together with cognitive deficit (problems with thought processes), may be in the pre-dementia stage of Alzheimer's disease. Such patients may therefore be suitable for inclusion of clinical trials of medicines that might slow the development of dementia. The hippocampus is a region of the brain that is involved in memory.
The opinion, which was developed in co-operation with the Critical Path Institute, is open for comments until 1 November 2011.
Biomarkers are tests that can be used to follow body processes and diseases in humans and animals. They can be used to predict how a patient will respond to a medicine or whether they have, or are likely to develop, a certain disease. On request, the Agency can give an opinion on the qualification of the use of a biomarker, to indicate its acceptability for a specific use in pharmaceutical research and development.
The Agency's Committee for Medicinal Products for Human Use (CHMP) issues biomarker qualification opinions, based on recommendations from its Scientific Advice Working Party (SAWP). The opinions are based on an assessment of data submitted to the Agency. The public is consulted on all such qualification opinions issued by the Agency.
This draft qualification opinion is the second that the Agency has issued for use in humans. The first such opinion, issued in February 2011, was also for the detection pre-dementia Alzheimer's disease and was based on the levels of two proteins in the blood.
- Public consultation: Qualification opinion of low hippocampal volume (atrophy) by magnetic resonance imaging for use in regulatory clinical trials - in pre-dementia stage of Alzheimer's disease
- Qualification of novel methodologies and biomarkers
- First clinical biomarker qualification released for public consultation (17/02/2011)