In July 2008, Nutricia Advanced Medical Nutrition took the first step towards introduction of its Alzheimer’s product Souvenaid®, when the successful high-level results of a first clinical trial of the product concept were presented at the International Congress on Alzheimer’s Disease (ICAD) in Chicago.
At the same time, Nutricia announced its decision to continue building the pyramid of evidence for the benefits of Souvenaid; and also to prepare a pathway for commercialization of the product. Today Nutricia is announcing the next steps on that path.
Souvenaid is a multi-nutrient drink designed to improve cognitive function, and is the result of more than ten years of research and development into the potential role of medical nutrition in neurological diseases. The first clinical trial took place between 2006 and 2008. The results of this trial, demonstrating proof of concept, are being published in the January 2010 issue of the peer-reviewed journal Alzheimer’s & Dementia.
To further build the evidence base for the benefits of Souvenaid, Nutricia has initiated three more clinical trials of the product. In the US, a study called ‘S-Connect’ began in early 2009, in co-operation with the Rush Alzheimer’s Disease Center, Chicago. In Europe, two studies also began in 2009 – ‘Souvenir II’ with the Medical Centre of the Vrije Universiteit in Amsterdam, The Netherlands; and the ‘LipiDiDiet’ consortium study led from Homburg in Germany. These trials are planned to involve up to 500 patients each, targeting various aspects of memory and cognition, and the results are expected to be available between 2011 and 2013.
Beginning in Spring 2010, Nutricia also intends to undertake a small scale Early Experience Program for consumers. The objective of the Program is to obtain as many learnings as possible from the market and the Alzheimer’s community, in advance of the launch of the product, and outside a formal clinical trial setting. While the three follow-up clinical trials continue to develop the scientific perspective for Souvenaid, the Early Experience Program will develop Nutricia’s understanding of patient and caregiver needs, partnership with doctors, and the potential marketplace for the product.
Commenting on these developments, Flemming Morgan, President of Nutricia Advanced Medical Nutrition said: “I am delighted with the progress we have made to prepare Souvenaid for the market. Souvenaid offers a unique approach to the support of people with early stage Alzheimer’s disease, which we believe will be welcomed by doctors and patients alike. We know that there is a substantial unmet need in this area, and our goal is to make a proven and positive difference in the lives of millions of people with Alzheimer’s and their carers.”
References:
1. Souvenaid.
