IngentaConnect A Randomized, Double-Blind, Placebo-Controlled Trial of Two Doses...

Authors: Schneider, Lon S.¹; DeKosky, Steven T.¹; Farlow, Martin R.¹; Tariot, Pierre N.¹; Hoerr, Robert¹; Kieser, Meinhard¹

Source: Current Alzheimer Research, Volume 2, Number 5, December 2005 , pp. 541-551(11)

Publisher: Bentham Science Publishers

Abstract:

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.

Keywords: Ginkgo biloba; dementia; Alzheimer's disease; treatment; randomized controlled trial

Document Type: Research article

Affiliations: 1: Keck School of Medicine, University of Southern California, 1510 San Pablo Street, HCC 600, Los Angeles, CA 90033, USA.

The full text article is available for purchase

$55.10 plus tax

A Randomized, Double-Blind, Placebo-Controlled Trial of Two Doses of Ginkgo Biloba Extract in Dementia of the Alzheimer's Type