The GuidAge study: methodological issues. A 5-year double-blind randomized trial of the efficacy of EGb 761 for prevention of Alzheimer disease in patients over 70 with a memory complaint.
BACKGROUND
Preventive approaches in the field of Alzheimer disease (AD) is important but these trials raise many questions. Which protective factor should be studied? What population should be studied? With which principal and secondary criteria? We present here the design of the ongoing GuidAge Study. In the past, several studies suggest that Ginkgo biloba could have a potential benefit effect on cognitive function. The aim of the GuidAge Study is to evaluate the efficacy of 240 mg/d of EGb 761 in the prevention of AD.


METHODS
GuidAge is a 5-year double-blind randomized trial conducted in France by a private practice/hospital network of general practitioners and hospital practitioners specializing in memory disorders. This study enrolled elderly subjects with spontaneous memory complaint and the primary outcome is the incidence of AD during a 5 years follow-up period. A total of 2854 subjects were enrolled between March 2002 and September 2004. The age of the study population was 76.8 +/- 4.4 with mean MMSE at entry 27.8 +/- 1.7.


CONCLUSIONS
The GuidAge study is the largest study carried out in Europe on the prevention of AD. Final results should be available in 2010.
Vellas
B
B
INSERM (French National Institute of Health and Medical Research), U558, F-31073 Toulouse, France. vellas.b@chu-toulouse.fr
Andrieu
S
S
Ousset
P J
PJ
Ouzid
M
M
Mathiex-Fortunet
H
H
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy / Q000517:prevention & control* / Q000523:psychology; D004311:Double-Blind Method; D020441:Ginkgo biloba; D006801:Humans; D008569:Memory Disorders / Q000188:drug therapy / Q000517:prevention & control* / Q000523:psychology; D010936:Plant Extracts / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000639:trends; D000096983:Ginkgo Extract
D010936:Plant Extracts; C063170:Ginkgo biloba extract; D000096983:Ginkgo Extract