A randomized, double-blind, placebo-controlled trial of two doses of Ginkgo biloba extract in dementia of the Alzheimer's type

Curr Alzheimer Res. 2005 Dec;2(5):541-51. doi: 10.2174/156720505774932287.


Context: Previous studies of Ginkgo biloba extract (GbE) in patients with various forms of cognitive impairment or dementia have shown promising results.

Objective: To determine the clinical efficacy of GbE in mild to moderate dementia of the Alzheimer type.

Design: Randomized, placebo-controlled, double-blind, parallel-group, multicenter trial.

Setting: Outpatient clinics of universities and private research centers specialized in dementia.

Patients: 513 outpatients with uncomplicated dementia of the Alzheimer's type scoring 10 to 24 on the Mini-Mental State Examination and less than 4 on the modified Hachinski Ischemic Score, free of other serious illnesses and not requiring continuous treatment with any psychoactive drug.

Intervention: 26-week treatment with GbE at daily doses of 120 mg or 240 mg or placebo.

Main outcomes: Cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC).

Results: There were no significant between-group differences for the whole sample. There was little cognitive and functional decline of the placebo-treated patients, however. For a subgroup of patients with neuropsychiatric symptoms there was a greater decline of placebo-treated patients and significantly better cognitive performance and global assessment scores for the patients on GbE.

Conclusion: The trial did not show efficacy of GbE, however, the lack of decline of the placebo patients may have compromised the sensitivity of the trial to detect a treatment effect. Thus, the study remains inconclusive with respect to the efficacy of GbE.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alzheimer Disease / drug therapy*
  • Double-Blind Method
  • Female
  • Ginkgo biloba / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Phytotherapy*
  • Placebos
  • Plant Extracts / administration & dosage*
  • Plant Extracts / adverse effects
  • Treatment Outcome


  • Placebos
  • Plant Extracts
  • Ginkgo biloba extract