Ihl R, Bachinskaya N, Korczyn AD, et al. Efficacy and safety of a once-daily formulation of Ginkgo biloba extract EGb 761 in dementia with neuropsychiatric features: a randomized controlled trial. Int J Geriatr Psychiatry. 2010; [epub ahead of print]. doi:10.1002/gps.2662.
Elderly patients with dementia have difficulty remembering to take their medicines. Once daily dosing improves treatment adherence. Ginkgo (Ginkgo biloba) is a popular treatment for memory loss; however, most ginkgo preparations require multiple daily dosing. The purpose of this randomized, double-blind, placebo-controlled study was to evaluate the safety and efficacy of a new once daily formulation of the ginkgo extract, EGb 761 (Dr. Willmar Schwabe; Karlsruhe, Germany). This once daily formulation consisted of a "dry extract from Ginkgo biloba leaves (drug-extract ratio 35-67:1), adjusted to 22.0-27.0% ginkgo flavonoids and 5.0-7.0% terpene lactones consisting of 2.8-3.4% ginkgolides A, B, C and 2.6-3.2% bilobalide, with a content of ginkgolic acids below 5 ppm."Men and women (≥ 50 years old) with symptoms of dementia for ≥ 6 months, and diagnosis of probable Alzheimer's disease (AD), possible AD with cerebrovascular disease (CVD), or probable vascular dementia (VaD) participated in the study. Patients (n = 410) were enrolled from 20 outpatient clinics of psychiatric or neurological hospitals in the Ukraine. A CT or MRI scan ≤ 1-year-old had to be available that provided evidence consistent with the diagnosis and showed no evidence of other brain lesions that could account for the cognitive deficit. Patients also had to have a screening score of ≥ 35 on the Test for Early Detection of Dementia with Discrimination from Depression (TE4D), a score of 9 to 23 on the Syndrom Kurz Test (SKT) battery, a score < 6 on the clock-drawing tests (CDT), a score of ≥ 5 on the 12-item Neuropsychiatric Inventory (NPI), and a score < 20 on the 17-item Hamilton Rating Scale for Depression (HAMD). Patients with severe dementia were excluded. Treatment with other memory enhancing drugs/herbs was prohibited during the study and for ≥ 8 weeks prior to randomization. The primary efficacy measures were the SKT and NPI scores. The secondary efficacy measures were the Clinical Global Impression of Change (CGIC), the Alzheimer's Disease Activities of Daily Living International Scale (ADL-IS), the dementia quality of life proxy scale (DEMQOL), the Verbal Fluency Test, NPI caregiver distress score, and patient self-ratings of dizziness and tinnitus. Efficacy assessments were made at baseline, week 12, and week 24. Safety assessments were done at screening and week 24; adverse events (AEs) were recorded at baseline and weeks 6 and 18.
Most patients had concomitant medical conditions. The most frequently reported conditions were: nervous system disorders (EGb 761: 89%, placebo: 93%), vascular disorders (EGb 761: 92%, placebo: 90%), and cardiac disorders (EGb 761: 74%, placebo: 74%). The baseline HAMD scores were > 15 and < 20 (indicating moderate depression) in 23 patients (EGb 761: 10, placebo: 13). Concomitant prescription medications were used by 67% of the patients.
According to the SKT total score, a clinically significant improvement in cognition occurred in 32% of EGb 761-treated patients and in 15% of placebo-treated patients (P < 0.001). According to the NPI total score, significant improvements occurred in 45% of EGb 761-treated patients and 24% of placebo-treated patients (P < 0.001). All secondary efficacy measures for EGb 761 were statistically significant in superiority over placebo.
—Heather S. Oliff, PhD