Ipsen reports top line results from European study of GuidAge for Alzheimer's Dementia

IpsenJun 22 2010

Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) today 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.

1. Primary efficacy objective (to delay conversion to Alzheimer's Dementia): significant difference not statistically observed in the overall study population: during the study, 134 individuals developed Alzheimer's Dementia, including 61 patients (4.3%) in the EGb 761^® group and 73 patients (5.2%) in the placebo group.

However, a statistically significant difference between EGb 761^® and placebo was observed in patients treated for a least 4 years: pre-specified planned statistical analyses suggest a difference in favour of EGb 761^® versus placebo on the conversion to Alzheimer's Dementia in patients treated for at least 4 years: 15 out of 947 patients (1.6%) in the EGb 761^® group with treatment duration of at least 4 years converted to Alzheimer's dementia versus 29 out of 966 (3.0%) in the placebo group.

These analyses suggest as well a statistically significant difference in favour of EGb 761^® in males: 14 out of 480 males (2.9%) in the EGb 761^® group converted to AD versus 32 out of 460 (7.0%) in the placebo group.

Complementary analyses will enable to further investigate these differences.

EGb 761^®'s favourable long-term safety profile was monitored and confirmed.

2. GuidAge^® study marks a milestone for future research on Alzheimer's Disease and for prevention strategies

Beyond clinical results, this major trial, which involved a total population of 2,854 patients at risk of developing Alzheimer's Disease, will provide large opportunities for further investigation by the scientific and medical communities. In particular, new perspectives were opened by the study:

• Forthcoming analyses of GuidAge^® results to identify the transition from subjective memory complaint to cognitive decline and dementia up to 5 years.
• Leverage of Alzheimer's disease research through the transfer from Ipsen to French academic research of a biobank constituted along the GuidAge^® trial and containing blood samples and DNA extraction from 2,107 patients.

GuidAge^® is therefore one of the main scientific contribution to neurodegenerative research in line with the French Government's strategy of fostering research and prevention in Alzheimer's dementia.

Pr. Bruno Vellas, Principal Investigator of the study, INSERM U558, Gérontopôle (Toulouse, France), said: "The specific characteristics of GuidAge^® study are on the one hand the target population (subjects aged of at least 70 with memory complaint spontaneously expressed to their family physician), and on the second hand, the cooperation between memory clinics and a network of 658 family physicians trained in clinical research, probably responsible for the noticeable compliance in 93 % of the intention-to-treat population. The results of this clinical trial, which will have to be investigated in further studies, are encouraging and open new perspectives."

Dr. Patrick Mérat, Senior Vice-President, Drug Development and Chief Medical Officer, Ipsen, said: "Ipsen is proud to have carried out the largest and longest European study in the prevention of Alzheimer's Dementia, thus contributing to a public health priority. We would like to express our gratitude to the renowned scientific and independent data monitoring committees as well as to the investigators and patients involved in the study. Ipsen is determined to pursue its long term commitment with academic investigators to advance knowledge in Alzheimer's disease by its intent to transfer GuidAge^® remarkable biological bank to French academic research. This biobank will represent a valuable source of knowledge in the Alzheimer's Disease area. Within the context of these results, it is Ipsen's intention to assess all the potential strategies so as to carry these findings further."