Zeitschrift für Phytotherapie 2006; 27 - V36
DOI: 10.1055/s-2006-954902

Ginkgo-biloba-Extract EGb 761®, donepezil or both combined in the treatment of Alzheimer's disease with neuropsychiatric features: A randomised, double-blind trial

S Yancheva 1, R Ihl 2, S Schlaefke 3 R Hoerr 3, for the GINDON Study Group
  • 1Hospital St. Naum, Sofia, Bulgaria
  • 2Alexianer Hospital Cologne, Cologne, Germany
  • 3Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany

In an exploratory trial we enrolled 94 outpatients, aged 50 years or above (mean age 67.4 years), suffering from mild to moderate Alzheimer's disease with neuropsychiatric features. To be eligible, patients had to fulfil the NINCDS/ADRDA diagnostic criteria for probable Alzheimer's disease, score below 36 on the TE4D, a brief screening test for dementia, below 6 on the Clock-Drawing Test (Sunderland scoring) and between 9 and 23 on the Syndrome Kurz-Test, a cross-culturally validated cognitive test battery. Their total score on the 12-item Neuropsychiatric Inventory had to be at least 5, with at least one item other than delusions or hallucinations rated 3 or higher. Patients were randomly assigned to receive Ginkgobiloba-extract EGb 761® (240mg per day), donepezil (5mg per day during a 4-week titration period, then 10mg per day) or EGb 761® and donepezil combined (at the same daily doses) for a period of 22 weeks. A double-dummy technique ensured double-blind treatment conditions. At week 22, changes from baseline and response rates were similar for all three treatment groups with respect to all outcome measures (Syndrome Kurz-Test, total score and distress score of the Neuropsychiatric Inventory, total score and activitiesof-daily-living subscore of the Gottfries-Bråne-Steen Scale, Hamilton Rating Scale for Depression, Clock-Drawing Test, Verbal Fluency Test, Concomitant Symptoms Scale for dizziness and tinnitus).

An apparent tendency in favour of combination treatment warrants further scrutiny.