The European Medicines Agency (EMA) has begun consulting on new guidelines for the development of medicines to treat Alzheimer’s disease and other types of dementias.
The European regulator wants to address the impact of new diagnostic criteria on clinical trial design as well as the design of long term efficacy and safety studies.
Its plans also look at the need for assessment tools that cater to different disease stages and potential uses of biomarkers.
In a statement, the EMA said: “ Recent progress in understanding the pathophysiology of Alzheimer’s disease suggest that the biological changes associated with the disease start to occur as early as 10 to 20 years prior to the emergence of clinical symptoms.
“Experimental medicines should therefore be evaluated in earlier disease stages as certain treatments many be more effective at that stage than later in the illness.”
The revised guidelines follow a November 2014 EMA workshop on the clinical investigation of Alzheimer’s medicines, which introduced new diagnostic criteria for Alzheimer’s disease.
Consequently early, and asymptomatic, disease stages and their impact in the make up of clinical trials for Alzheimer’s drugs are also included in the EMA’s revised guidelines.
The EMA considers dementia a key public health priority and has worked with patient representatives, regulators, the pharmaceutical industry and independent experts while compiling the draft guidelines.
Although the last few years have seen a number of Alzeimer’s diagnostics approved, among them GE Healthcare Vizamyl (flutemetamol) and Piramal’s Neuraceq (florbetaben F18), research progress for a treatment has been slow.
Last year Roche and Evotec’s sembragiline failed a phase II trial and Pfizer this week announced it has halted development of its candidate, PF-05212377, after it too failed to meet objectives in a phase II trial.
The consultation runs until 31 July 2016. For more information, see the EMA’s draft Alzheimer’s medicine research guideline