[Effectiveness of brief infusions with Ginkgo biloba Special Extract EGb 761 in dementia of the vascular and Alzheimer type].
In a placebo-controlled, randomized, double-blind clinical trial, 40 patients with a mean age of 68 (+/- 12.5) years suffering from moderate dementia (Alzheimer, vascular, or mixed type) according to DSM-III-R criteria were included. Severity of the disease had to correspond to stages 4 or 5 of Reisberg's Global Deterioration Scale. Infusions of either EGb 761 or placebo were administered 4 days per week for 4 weeks. Primary outcome measure was the activities of daily living as assessed by the Nürnberger-Alters-Beobachtungsskala (NAB). The Clinical Global Impressions of change (CGI, item 2) and the actual intelligence as assessed by the Kurztest für Allgemeine Intelligenz (KAI) were further target variables. No relevant group differences could be detected at baseline. After therapy, patients of the active substance group scored significantly better (p < 0.05) on each outcome measure than those who received placebo. Using a sequential testing procedure, a global significance level of p < 0.05 could be assured. Superiority of EGb 761 therapy was also found with respect to a self-rating scale for instrumental activities of daily living (Nürnberger-Alters-Alltagsaktivitätenskala), the improvement of the most prominent symptom of illness, and the decrease of depression. Thus clinical efficacy of EGb 761 could be shown on three planes of assessment: the behavioral, the psychopathologic and the psychometric plane. It could be confirmed that, in patients with moderate dementia, short-term intravenous infusion therapy with EGb 761 results in an improvement of psychopathology and cognitive performance, which is reflected in an increased ability to cope with the demands of daily living.
Haase
J
J
Universitätsklinikum Charité Klink für Innere Medizin, Berlin.
Halama
P
P
Hörr
R
R
D000203:Activities of Daily Living / Q000145:classification; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000175:diagnosis / Q000188:drug therapy*; D015161:Dementia, Multi-Infarct / Q000175:diagnosis / Q000188:drug therapy*; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D016166:Free Radical Scavengers / Q000008:administration & dosage*; D020441:Ginkgo biloba; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010936:Plant Extracts / Q000008:administration & dosage*; D016896:Treatment Outcome; D000096983:Ginkgo Extract
D016166:Free Radical Scavengers; D010936:Plant Extracts; C063170:Ginkgo biloba extract; D000096983:Ginkgo Extract
Wirksamkeit kurzdauernder Infusionsbehandlungen mit Ginkgo-biloba-Spezialextrakt EGb 761 bei Demenz vom vaskulären und Alzheimer-Typ.