title: Efficacy and safety of a once-daily formulation of Ginkgo biloba extract EGb 761 in dementia with neuropsychiatric features: a randomized controlled trial.
abstract: OBJECTIVE
  To test the efficacy and safety of a once-daily formulation of EGb 761 in the treatment of patients with dementia with neuropsychiatric features.
  
  
  METHODS
  Multi-centre trial of 410 outpatients with mild to moderate dementia (Alzheimer's disease, vascular dementia or mixed form) scoring between 9 and 23 on the SKT cognitive test battery, at least five on the Neuropsychiatric Inventory (NPI) and three or higher in at least one item of the NPI. Patients were randomly allocated to double-blind treatment with 240 mg of EGb 761 or placebo once daily for 24 weeks. Primary outcomes were the changes from baseline in the SKT total score and the NPI total score. The Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC), Activities of Daily Living International Scale (ADL-IS), NPI distress score, DEMQOL-Proxy quality-of-life scale and Verbal Fluency Test were secondary outcomes.
  
  
  RESULTS
  At endpoint, patients treated with EGb 761 (n = 202) improved by -1.4 (95% confidence interval -1.8; -1.0) points on the SKT and by -3.2 (-4.0; -2.3) on the NPI total score, whereas those receiving placebo (n = 202) deteriorated by +0.3 (-0.1; 0.7) on the SKT and did not change on the NPI total score (-0.9; 0.9). Both drug-placebo comparisons were significant at p < 0.001. EGb 761 was significantly superior to placebo with respect to all secondary outcome measures. Adverse event rates were similar for both treatment groups.
  
  
  CONCLUSIONS
  EGb 761, 240 mg once-daily, was found significantly superior to placebo in the treatment of patients with dementia with neuropsychiatric symptoms.
authors.affiliation: Geriatric Psychiatry Centre, Alexian Hospital Maria-Hilf, Krefeld and Department of Psychiatry and Psychotherapy, University of Duesseldorf, Germany. ralf.ihl@t-online.de.
authors.forename: Ralf
authors.initials: R
authors.lastname: Ihl
authors.forename: Natalia
authors.initials: N
authors.lastname: Bachinskaya
authors.forename: Amos D
authors.initials: AD
authors.lastname: Korczyn
authors.forename: Veronika
authors.initials: V
authors.lastname: Vakhapova
authors.forename: Michael
authors.initials: M
authors.lastname: Tribanek
authors.forename: Robert
authors.initials: R
authors.lastname: Hoerr
authors.forename: Oleksandr
authors.initials: O
authors.lastname: Napryeyenko
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D003704:Dementia / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D016166:Free Radical Scavengers; D020441:Ginkgo biloba; D006801:Humans; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D000096983:Ginkgo Extract
chemical_list: D016166:Free Radical Scavengers; D018696:Neuroprotective Agents; D010936:Plant Extracts; C063170:Ginkgo biloba extract; D000096983:Ginkgo Extract