Dementia drug development: use of information systems to harmonize global drug development

Dementia is a worldwide problem with regional differences in distribution. In North America and Western Europe, it is estimated that approximately 70 percent of all cases of dementia are caused by Alzheimer's disease (AD) and 15 percent by vascular dementia. Infectious and metabolic causes of chronic cognitive impairment are more common than AD in developing countries, but as the populations of these countries continue to age rapidly, the problem of age-related dementias such as AD will become enormous. Around the world, numerous medications have been approved for the treatment of dementia, although relatively few have been approved specifically for AD. In Japan, for example, over 20 medications have been approved, primarily for the treatment of vascular dementia, but they are also used for other dementias. Most of these drugs would not meet current standards for efficacy (i.e., Food and Drug Administration or European Union proposed guidelines, or de facto standards set by the approval of tacrine), although most are safe. Similarly, in Europe there are wide variations in available drugs, and many might not be approved if introduced today. This article discusses the International Working Group for the Harmonization of Dementia Drug Guidelines, a collaborative effort to develop safe, effective treatments for dementia by promoting harmonization of regulatory guidelines and multisite, multinational studies to produce global dossiers. It focuses on the use of information systems to achieve this goal.