WHAT IS THE INFLUENCE ON CLINICAL RESEARCH OF THE EMA GUIDELINE ON MEDICINAL PRODUCTS FOR THE TREATMENT OF ALZHEIMER'S DISEASE?
Author(s)
Caron M, Acquadro C, Emery MPMAPI Research Trust, Lyon, France
Presentation Documents
OBJECTIVES: In 2009, the EMA published a guideline on medicinal products for the treatment of Alzheimer’s disease. The guideline stipulates that symptoms improvement should be assessed in cognition (cognitive endpoint), activities of daily living (functional endpoint) and overall clinical response (global endpoint). The two primary endpoints should reflect the cognitive and functional domains. Global assessment should be evaluated as a secondary endpoint. The objective of this study is to review all products authorized by the EMA for the treatment of Alzheimer’s before and after the publication of the guidance to see if the guidance had any influence on clinical research or is only making existing practices official. METHODS: The EMA website was searched with the keyword “Alzheimer” (EPAR section, Keyword search). All EPARs and Scientific Discussions corresponding to Alzheimer’s medicines were downloaded and reviewed. RESULTS: Ten products were retrieved representing only two active substances: rivastigmine (8), and memantine hydrochloride (2). Four medicines were approved before the publication of the guidance, and six afterwards (all generics of rivastigmine). The review of the rivastigmine documents shows that the same studies were used for all products, and that primary endpoints were cognitive and global; functional was secondary. The review of the memantime documents shows that the same studies were used for all products. For two studies, the EMA advised the sponsors that primary endpoints should be functional and global; cognitive was secondary. For two other studies, global and cognitive measures were primary endpoints; functional was secondary. CONCLUSIONS: Before 2009, symptoms improvement is assessed in the three recommended domains. The primary and secondary endpoints, however, were not always consistent with those advised by the guideline, and sometimes contradicted them. The review cannot show any influence of the guidance on clinical research since all products approved after its publication are generics of rivastigmine.
Conference/Value in Health Info
2012-06, ISPOR 2012, Washington, D.C., USA
Value in Health, Vol. 15, No. 4 (June 2012)
Code
PND39
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Neurological Disorders, Respiratory-Related Disorders