KARLSRUHE, Germany--(BUSINESS WIRE)--Patients with neuropsychiatric symptoms resulting from mild to moderate vascular dementia, Alzheimer’s disease or mixed forms of dementia benefit from therapy with the Ginkgo biloba special extract EGb 761®. A new randomised, double-blind, placebo-controlled, multicentre study with 402 patients1 confirms this conclusion: Both cognition and behavioural problems improved significantly after 24 weeks. Although up to 80 percent of dementia patients suffer from neuropsychiatric symptoms 2,3 these are frequently excluded from dementia studies according to the author of the study, Prof. Horst Herrschaft, Cologne. For this reason, the current study findings are particularly valuable for everyday practice.
The primary objective of the study was to provide evidence of a simultaneous improvement in cognitive and neuropsychiatric symptoms over 24 weeks. Cognition was recorded with the SKT (Syndrom-Kurztest – short syndrome test)4,5 and neuropsychiatric symptoms with the NPI (Neuropsychiatric Inventory)6. The active substance group (n = 200), taking 240 mg Ginkgo biloba special extract EGb 761® once a day, achieved a significant improvement compared to the placebo group (n = 202) in both the SKT and the NPI (SKT: 2.2 vs. 0.3 points; NPI: 4.6 points vs. 2.1 points; both p < 0.001). The primary objective of the study was thus achieved.
Neuropsychiatric symptoms are highly relevant to everyday life
“Most of the dementia patients in everyday practice suffer from neuropsychiatric symptoms”, Herrschaft emphasizes. “We specifically investigated this typical patient group using a controlled study design. The inclusion of both patients with Alzheimer’s disease and vascular dementia, as well as mixed forms of dementia, was also particularly relevant to everyday practice. Furthermore, as far as possible, patients who had not been previously treated with antidementia agents were included. The fact that we were able to demonstrate an improvement in neuropsychiatric symptoms with EGb 761® in our study group was important not only for the well-being of the patients but also, notably, for the relatives. These experience relief, which we were also able to document by a significant improvement in the NPI Caregiver Distress Score”.
Better quality of life and very good tolerability
The patients treated with EGb 761® also achieved significantly better results than the placebo group in the majority of secondary outcomes, which measured everyday functioning and quality of life. In the study, patients with Alzheimer’s disease and patients with vascular dementia showed a comparable degree of improvement with EGb 761®.
The tolerability profile of EGb 761® was comparable to that of placebo. The most frequent adverse event was headache, which was reported by 8.3 percent of the placebo patients and 7.3 percent of the active substance group. Dizziness occurred significantly less frequently under treatment with EGb 761® than in the placebo group (2.0 vs. 7.3 percent).
Study population
The study included 402 outpatients from 17 neurological or psychiatric clinics. These patients were suffering from mild to moderate vascular dementia, Alzheimer’s disease or mixed forms, together with neuropsychiatric symptoms. The mean duration of illness was 3 years. Most of the patients (n=355) had not been treated previously with antidementia agents. Diagnosis of dementia was performed according to the internationally-recognised NINCDS-ADRDA criteria7 or NINDS-AIREN criteria8. On inclusion, the patients had an SKT-score of 9-23 and at least 6 points in the NPI. At least one of the items “Anxiety”, “Apathy/Indifference”, “Irritability/Lability” or “Depression/ Dysphoria” had to reach 4 points or more in the NPI at baseline.
About EGb 761®
EGb 761® is a patented Ginkgo biloba special extract developed by Schwabe Pharmaceuticals. It is widely accepted as the best researched phytomedicine worldwide and is available in more than 70 countries, approved for the treatment of cognitive disorders such as dementia.
Dr. Willmar Schwabe
Is a world leader in the development and production of plant-based pharmaceuticals (phytomedicines). The Schwabe group, with headquarters in Karlsruhe, Germany, employs around 3,700 staff across five continents.
Literature:
1) Herrschaft H et al. Ginkgo biloba extract EGb 761(®) in dementia with neuropsychiatric features: A randomised, placebo-controlled trial to confirm the efficacy and safety of a daily dose of 240 mg. J Psychiatr Res. 2012 Mar 27. [Epub ahead of print]
2) Di Iulio F et al; Ocurrence of neuropsychiatric symptoms and psychiatric disorders in mild Alzheimer´s disease and mild cognitive impairment subtypes. International Psychogeriatrics 2010; 22:629-40
3) Steinberg M et al; Point and 5-year prevalence of neuropsychiatric symptoms in dementia: the Cache County Study. International Journal of Geriatric Psychiatry 2008; 23:170-7
4) Erzigkeit H. SKT manual. A short cognitive performance test for assessing memory and attention. Concise version. Geromed: Castrop-Rauxel; 1992
5) Kim YS, Nibbelink DW, Overall JE. Factor structure and scoring of the SKT test battery. Journal of Clinical Psychology 1993; 49:61e71
6) Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology 1997; 48(Suppl. 6):S10e6
7) McKhann G et al. Clinical diagnosis of Alzheimer’s disease: report of the NINCDS-ADRDA work group under the auspices of department of health and human services task force on Alzheimer’s disease. Neurology 1984; 34:939e44
8) Román GC et al. Vascular dementia: diagnostic criteria for research studies. Report of the NINDS-AIREN International Workshop. Neurology 1993; 43:250e60