EMA releases revised guidance to fight early onset Alzheimer's disease
Aims to help pharmaceutical companies produce treatments targeting the disease’s early onset
The European Medicines Agency (EMA) has released draft revised guidance on the development of medicines treating Alzheimer’s disease, with the aim of helping pharmaceutical companies produce treatments targeting the disease’s early onset.
EMA is responding to research suggesting that biological changes associated with the disease start to occur as early as 10 to 20 years prior to clinical symptoms.
'Experimental medicines should therefore be evaluated in earlier disease stages as certain treatments may be more effective at that stage than later in the illness,' said EMA.
As a result, the regulator has released guidance that considers the impact of new diagnostic criteria for Alzheimer’s disease, including early onset, on clinical trials; helping measure trial outcomes by using distinct assessment tools for different disease stages; using biomarkers to assess different phases of Alzheimer’s disease and related medicines (including setting out patient sub-groups for analysis); and designing of long-term efficacy and safety studies.