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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.
Reference:
Curr Alzheimer Res. 2005 Dec;2(5):541-51. |