Future prospects for Alzheimer's disease therapy: ethical and policy issues for the international community

In addition to being driven by basic scientific research and the preclinical and clinical evaluation of promising new compounds, the development of drugs for patients with Alzheimer's disease (AD) must also be guided by public policy and ethical considerations. More carefully coordinated efforts should be devoted to reducing caregiver burden and providing community-based health care services for patients with chronic as opposed to acute diseases. Important ethical issues include the appropriate duration of double-blind, placebo-controlled clinical trials, the determination of the meaning of "informed consent" when dealing with patients with dementia, the establishment of outcome goals for various stages of the disease process, and the provision of appropriate hospice-type care. The establishment of the International Working Group on Harmonization of Dementia Drug Guidelines is an important step in the process of achieving an international approach toward the development and evaluation of drugs for patients with AD.