In 1996, the Japanese Ministry of Health and Welfare organized a working group to develop guidelines to assess the clinical efficacy of drugs used to treat dementia. The major issues discussed at that time included the definition of antidementia drugs, outcome measures, concomitant treatments, and placebo issues. Because the primary objective of this group was to develop guidelines for the symptomatic treatment of the disease, issues related to slowing of disease progression and behavioral and psychological symptoms of dementia (BPSD) were not discussed in detail. In 1997, the group submitted a draft report to the Japanese Ministry of Health and Welfare. It is hoped that in the future, this group will address issues not discussed in the draft guidelines.