A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL OF AN EXTRACT OFGINKGO-BILOBA FOR DEMENTIA

Context.-EGb 761 is a particular extract of Ginkgo biloba used in Euro pe to alleviate symptoms associated with numerous cognitive disorders, Its use in dementias is based on positive results from only a few con trolled clinical trials, most of which did not include standard assess ments of cognition and behavior.Objective.-To assess the efficacy and safety of EGb in Alzheimer disease and multi-infarct dementia. Design. -A 52-week, randomized double-blind, placebo-controlled, parallel-grou p, multicenter study. Patients.-Mildly to severely demented outpatient s with Alzheimer disease or multi-infarct dementia, without other sign ificant medical conditions. Intervention.-Patients assigned randomly t o treatment with EGb (120 mg/d) or placebo, Safety, compliance, and dr ug dispensation were monitored every 3 months with complete outcome ev aluation at 12, 26, and 52 weeks. Primary Outcome Measures.-Alzheimer' s Disease Assessment Scale-Cognitive subscale (ADAS-Cog), Geriatric Ev aluation by Relative's Rating Instrument (GERRI), and Clinical Global Impression of Change (CGIC). Results.-From 309 patients included in an intent-to-treat analysis, 202 provided evaluable data for the 52-week end point analysis, In the intent-to-treat analysis, the EGb group ha d an ADAS-Cog score 1.4 points better than the placebo group (P=.04) a nd a GERRI score 0.14 points better than the placebo group (P=.004). T he same patterns were observed with the evaluable data set in which 27 % of patients treated with EGb achieved at least a 4-point improvement on the ADAS-Cog, compared with 14% taking placebo (P=.005); on the GE RRI, 37% were considered improved with EGb, compared with 23% taking p lacebo (P=.003). No difference was seen in the CGIC, Regarding the saf ety profile of EGb, no significant differences compared with placebo w ere observed in the number of patients reporting adverse events or in the incidence and severity of these events. Conclusions.-EGb was safe and appears capable of stabilizing and, in a substantial number of cas es, improving the cognitive performance and the social functioning of demented patients for 6 months to 1 year. Although modest, the changes induced by EGb were objectively measured by the ADAS-Cog and were of sufficient magnitude to be recognized by the caregivers in the GERRI.