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

DOI: 10.2174/156720505774932287

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

The full text electronic article is available for purchase. You will be able to download the full text electronic article after payment.

$55.10 plus tax Refund Policy

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