What Has Changed in Clinical Drug Trials for Behavioral and Psychological Symptoms of Dementia?

Extract

When the International Psychogeriatric Association (IPA) held its consensus meeting in 1996, we reviewed the placebo-controlled, double-blind, randomly assigned clinical drug trials on the behavioral and psychological symptoms of dementia (BPSD) in the worldwide literature (Finkel, 1996). We learned that prior to 1990, only seven such studies utilizing antipsychotic medications were published. Those occurred between 1960 and 1982 (Schneider et al., 1990), and only one (Barnes et al., 1982) took place in a nursing home. These early studies suffered from many shortcomings, including the use of high doses of medication for this population, measurements and scales developed for younger schizophrenic and bipolar patients, and lengths of studies that were too short to allow full washout in those elderly previously taking medication (Devanand, 1996; Finkel, 1996). Further, six of the seven studies utilized the softer diagnostic criteria characteristic of DSM-I and DSM-II. Several other clinical trials examined benzodiazepines (Schneider & Sobin, 1991) which, overall, showed a lesser therapeutic effect than the neuroleptic medication. None of these research studies appeared to be financially supported by industry.