22 June 2010 - Primary efficacy objective (to delay conversion to Alzheimer’s Dementia): - Unmet in overall study population, Met in patients treated for a duration of at least 4 years - The GuidAge® study marks a milestone for future research on Alzheimer’s Disease and for prevention strategies - Ipsen intends to transfer a unique biobank to French Academic research - Ipsen (Euronext: IPN; ADR: IPSEY) announced top line results of GuidAge®, the longest (5 years) and largest (2,854 subjects) European study in the prevention of Alzheimer’s Dementia (AD). This trial was conducted according to the most stringent international standards. The aim of this study was to assess the efficacy of a 5-year treatment with EGb 761® in the prevention of Alzheimer’s Dementia in a population of elderly aged 70 or more, with memory complaint spontaneously expressed to their family physician and who lived at home at the inclusion in the study...[...]
...About EGb 761®
EGb 761®, which is the active substance of Tanakan®, is a unique standardized extract of Ginkgo biloba. This compound features antioxidant and neuroprotective property as well as an action on β-amyloid protein in experimental models. Its consistent composition in pharmacologically active substances is achieved through specially designed plantations of Ginkgo biloba (dioecious tree in the Ginkgoaceae family) that are cultivated under controlled conditions and a standardised extraction and purification process. EGb 761® is indicated and registered in many countries for the treatment of cognitive disorders in the elderly as well as neurosensory disorders.
About GuidAge®
The aim of the GuidAge® study was to assess the efficacy of EGb 761® at a dose of 240 mg daily in the prevention of Alzheimer’s Dementia (AD) in a population of subjects aged 70 or more with a memory complaint spontaneously expressed to their family physician and living at home at the inclusion. GuidAge® is the longest and largest European study in this disease and has been conducted in full compliance with the most stringent international standards. GuidAge® was a 5-year double-blind randomized trial versus placebo conducted in France by a network of family physicians and memory clinics. The primary endpoint was the incidence of AD during a 5-year follow-up period. A total of 2,854 subjects were enrolled between March 2002 and November 2004. At entry, the mean age of the study population was 76.3 (±4.4), with mean MMSE (Mini Mental State Evaluation) at entry of 27.6 (± 1.9). Last patient last treatment date was November 2009.
The outcomes of the study pointed out that 134 individuals developed dementia of Alzheimer’s type, including 61 patients (4.3%) in the EGb 761® group and 73 patients (5.2%) in the placebo group; this difference was not significant (p=0.31). Global conversion rate found in the placebo group (5.2%) was 50% lower than usually reported in the general French population. In planned pre-specified analysis, results were in favour of EGb 761® in patients treated for at least 4 years (1.6% versus 3.0% in the placebo group, p=0.03) and in males (2.9% versus 7.0% in the placebo group, p=0.007).
Both the dose and indication in the GuidAge® study are not approved by regulatory authorities... [PDF] Ipsen's Press Release -
