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


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


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


METHODS
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.


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


RESULTS
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.


CONCLUSIONS
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.
Schneider
Lon S
LS
Department of Psychiatry and the Behavioral Sciences, Keck School of Medicine, University of Southern California, Los Angeles, 90033, USA. lschneid@usc.edu
DeKosky
Steven T
ST
Farlow
Martin R
MR
Tariot
Pierre N
PN
Hoerr
Robert
R
Kieser
Meinhard
M
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D020441:Ginkgo biloba / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010919:Placebos; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D000096983:Ginkgo Extract
D010919:Placebos; D010936:Plant Extracts; C063170:Ginkgo biloba extract; D000096983:Ginkgo Extract