International Psychogeriatrics
Volume 15, Supplement 1 - 2003
Regulatory Issues in Vascular Dementia: A European Perspective KARL BROICH
ABSTRACT. In many studies vascular dementia (VaD) is the second most frequent cause of organic
acquired cognitive dysfunction; accounting for 10% to 50% of the cases, depending on the
geographical area, patient population, and diagnostic criteria used. There is growing evidence
that VaD does not include only multi-infarct dementia (MID) but relates to complex interactions
of different etiologies (risk factors, cerebrovascular disease), structural changes in the
brain, host factors and cognition. This resulted in reconceptualization of VaD to emphasize the
differences from Alzheimer’s disease (AD). However, the diagnostic criteria used (DSM-IV,
ICD-10, NINDS-AIREN, or ADDTC) are based on the experience with AD and as such have their
limitations and are not interchangeable. From a regulatory point of view, therefore, future
research is needed to better define VaD in general and possible subtypes of VaD as targets for
drug trials. Methodological issues in VaD trials, as opposed to AD, will be emphasized. The
European Medicinal Products Evaluation Agency (EMEA) has adopted a guideline for trials of
symptomatic treatments of dementia, particularly in AD. There is no explicit guideline for VaD
trials; however, many of the recommendations for AD are already applicable to VaD for drugs
aiming at alleviating symptoms of dementia. On the other hand, VaD may be potentially
preventable, underscoring the importance of primary and secondary prevention as in other
cerebrovascular disorders. Large long-term trials are necessary to study the importance of
different risk factors and possible intervention strategies with special reference to
VaD.
