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Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial.
Lancet Neurol 2012; 11(10):851-9LN

Abstract

BACKGROUND

Prevention strategies are urgently needed to tackle the growing burden of Alzheimer's disease. We aimed to assess efficacy of long-term use of standardised ginkgo biloba extract for the reduction of incidence of Alzheimer's disease in elderly adults with memory complaints.

METHODS

In the randomised, parallel-group, double-blind, placebo-controlled GuidAge clinical trial, we enrolled adults aged 70 years or older who spontaneously reported memory complaints to their primary-care physician in France. We randomly allocated participants in a 1:1 ratio according to a computer-generated sequence to a twice per day dose of 120 mg standardised ginkgo biloba extract (EGb761) or matched placebo. Participants and study investigators and personnel were masked to study group assignment. Participants were followed-up for 5 years by primary-care physicians and in expert memory centres. The primary outcome was conversion to probable Alzheimer's disease in participants who received at least one dose of study drug or placebo, compared by use of the log-rank test. This study is registered with ClinicalTrials.gov, number NCT00276510.

FINDINGS

Between March, 2002, and November, 2004, we enrolled and randomly allocated 2854 participants, of whom 1406 received at least one dose of ginkgo biloba extract and 1414 received at least one dose of placebo. By 5 years, 61 participants in the ginkgo group had been diagnosed with probable Alzheimer's disease (1·2 cases per 100 person-years) compared with 73 participants in the placebo group (1·4 cases per 100 person-years; hazard ratio [HR] 0·84, 95% CI 0·60-1·18; p=0·306), but the risk was not proportional over time. Incidence of adverse events was much the same between groups. 76 participants in the ginkgo group died compared with 82 participants in the placebo group (0·94, 0·69-1·28; p=0·68). 65 participants in the ginkgo group had a stroke compared with 60 participants in the placebo group (risk ratio 1·12, 95% CI 0·77-1·63; p=0·57). Incidence of other haemorrhagic or cardiovascular events also did not differ between groups.

INTERPRETATION

Long-term use of standardised ginkgo biloba extract in this trial did not reduce the risk of progression to Alzheimer's disease compared with placebo.

FUNDING

Ipsen.

Authors+Show Affiliations

INSERM U1027, Toulouse, France. vellas.b@chu-toulouse.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

22959217

Citation

Vellas, Bruno, et al. "Long-term Use of Standardised Ginkgo Biloba Extract for the Prevention of Alzheimer's Disease (GuidAge): a Randomised Placebo-controlled Trial." The Lancet. Neurology, vol. 11, no. 10, 2012, pp. 851-9.
Vellas B, Coley N, Ousset PJ, et al. Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial. Lancet Neurol. 2012;11(10):851-9.
Vellas, B., Coley, N., Ousset, P. J., Berrut, G., Dartigues, J. F., Dubois, B., ... Andrieu, S. (2012). Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial. The Lancet. Neurology, 11(10), pp. 851-9. doi:10.1016/S1474-4422(12)70206-5.
Vellas B, et al. Long-term Use of Standardised Ginkgo Biloba Extract for the Prevention of Alzheimer's Disease (GuidAge): a Randomised Placebo-controlled Trial. Lancet Neurol. 2012;11(10):851-9. PubMed PMID: 22959217.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial. AU - Vellas,Bruno, AU - Coley,Nicola, AU - Ousset,Pierre-Jean, AU - Berrut,Gilles, AU - Dartigues,Jean-François, AU - Dubois,Bruno, AU - Grandjean,Hélène, AU - Pasquier,Florence, AU - Piette,François, AU - Robert,Philippe, AU - Touchon,Jacques, AU - Garnier,Philippe, AU - Mathiex-Fortunet,Hélène, AU - Andrieu,Sandrine, AU - ,, Y1 - 2012/09/06/ PY - 2012/9/11/entrez PY - 2012/9/11/pubmed PY - 2012/12/10/medline SP - 851 EP - 9 JF - The Lancet. Neurology JO - Lancet Neurol VL - 11 IS - 10 N2 - BACKGROUND: Prevention strategies are urgently needed to tackle the growing burden of Alzheimer's disease. We aimed to assess efficacy of long-term use of standardised ginkgo biloba extract for the reduction of incidence of Alzheimer's disease in elderly adults with memory complaints. METHODS: In the randomised, parallel-group, double-blind, placebo-controlled GuidAge clinical trial, we enrolled adults aged 70 years or older who spontaneously reported memory complaints to their primary-care physician in France. We randomly allocated participants in a 1:1 ratio according to a computer-generated sequence to a twice per day dose of 120 mg standardised ginkgo biloba extract (EGb761) or matched placebo. Participants and study investigators and personnel were masked to study group assignment. Participants were followed-up for 5 years by primary-care physicians and in expert memory centres. The primary outcome was conversion to probable Alzheimer's disease in participants who received at least one dose of study drug or placebo, compared by use of the log-rank test. This study is registered with ClinicalTrials.gov, number NCT00276510. FINDINGS: Between March, 2002, and November, 2004, we enrolled and randomly allocated 2854 participants, of whom 1406 received at least one dose of ginkgo biloba extract and 1414 received at least one dose of placebo. By 5 years, 61 participants in the ginkgo group had been diagnosed with probable Alzheimer's disease (1·2 cases per 100 person-years) compared with 73 participants in the placebo group (1·4 cases per 100 person-years; hazard ratio [HR] 0·84, 95% CI 0·60-1·18; p=0·306), but the risk was not proportional over time. Incidence of adverse events was much the same between groups. 76 participants in the ginkgo group died compared with 82 participants in the placebo group (0·94, 0·69-1·28; p=0·68). 65 participants in the ginkgo group had a stroke compared with 60 participants in the placebo group (risk ratio 1·12, 95% CI 0·77-1·63; p=0·57). Incidence of other haemorrhagic or cardiovascular events also did not differ between groups. INTERPRETATION: Long-term use of standardised ginkgo biloba extract in this trial did not reduce the risk of progression to Alzheimer's disease compared with placebo. FUNDING: Ipsen. SN - 1474-4465 UR - https://www.unboundmedicine.com/medline/citation/22959217/Long_term_use_of_standardised_Ginkgo_biloba_extract_for_the_prevention_of_Alzheimer's_disease__GuidAge_:_a_randomised_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1474-4422(12)70206-5 DB - PRIME DP - Unbound Medicine ER -