PROOF OF EFFICACY OF THE GINKGO-BILOBA SPECIAL EXTRACT EGB-761 IN OUTPATIENTS SUFFERING FROM MILD-TO-MODERATE PRIMARY DEGENERATIVE DEMENTIAOF THE ALZHEIMER-TYPE OR MULTIINFARCT DEMENTIA

The efficacy of the ginkgo biloba special extract EGb 761 in outpatien ts with presenile and senile primary degenerative dementia of the Alzh eimer type (DAT) and multi-infarct dementia (MID) according to DSM-III -R was investigated in a prospective, randomized, double-blind, placeb o-controlled, multi-center study. After a 4-week run-in period, 216 pa tients were included in the randomized 24-week treatment period. These received either a daily oral dose of 240 mg EGb 761 or placebo. In ac cordance with the recommended multi-dimensional evaluation approach, t hree primary variables were chosen: the Clinical Global Impressions (C GI Item 2) for psychopathological assessment, the Syndrom-Kurztest (SK T)(1) for the assessment of the patient's attention and memory, and th e Nurnberger Alters-Beobachtungsskala (NAB)(2) for behavioral assessme nt of activities of daily life. Clinical efficacy was assessed by mean s of a responder analysis, with therapy response being defined as resp onse in at least two of the three primary variables. The data from the 156 patients who completed the study in accordance with the study pro tocol were taken into account in the confirmatory analysis of valid ca ses. The frequency of therapy responders in the two treatment groups d iffered significantly in favor of EGb 761, with p < 0.005 in Fisher's Exact Test. The intent-to-treat analysis of 205 patients led to simila r efficacy results. Thus, the clinical efficacy of the ginkgo biloba s pecial extract EGb 761 in dementia of the Alzheimer type and multi-inf arct dementia was confirmed. The investigational drug was found to be well tolerated.