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- Ginkgo (Ginkgo biloba)
- EGb 761
- Dementia
| | Date:
05-13-2011 | HC#
011153-424
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Re: Once Daily Dosing of Ginkgo Extract Demonstrates Advantages in Dementia
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
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