With the IHD-Amy test, IHD is making it possible to have a diagnostic test based on a peripheral biochemical marker, which is therefore straightforward and economic to carry out, making it one of the most promising ways forward in the research into the diagnosis of Alzheimer’s disease. In addition to this, the fact that this kind of test is carried out at an early stage means that treatment can be followed through far more efficiently, and also means that patient hospitalisation can be delayed. On a longer term basis, this kind of test could be a useful diagnostic tool and a crucial element of the establishment of a proactive public health policy initiative. The development of these tests is made possible by recent advances in medical knowledge and the discovery of fluorescent probes that can detect proteins that are specific to the disease. Just one drop of blood – 100 to 200 micro litres – is enough to carry out an analysis. These blood tests have the advantage of being quick, minimally invasive, and economic to carry out: just like the IHD-Amy test.

The specific IHD-Amy test – 83% sensitivity and 82% specificity!

Using just one drop of blood, this test can identify the interaction that takes place between a peptide (peptide ß-amyloid 1-42) and the red blood cell membranes using a peptide fluorescent probe. This interaction takes place in patients who have Alzheimer’s disease. This test is very specific to the disease as it detects a significant major protein from the time it appears and throughout its evolution. The proof of concept for this test was obtained following a first clinical trial which was concluded at the end of 2010. Additionally it has been successfully performed on animal models of the disease. The test also could enable early detection and monitoring of the disease if it targets the amyloid trajectory. The IHD-Amy yielded comparable performances on cellular and animal models of Alzheimer’s disease, making it a very high-performing tool for pharmaceutical manufacturers for the approval of preclinical and clinical phase medicines of the future.

IHD President Xavier Regnaut commented that “The results of our study with IHD-Amy demonstrate that this is one of the best performing tests around, which validates its real potential as a diagnostic aid tool for doctors in the future.” He went on to say that “These first results are very promising, and the clinical development schedule that we are working to should mean that we can confirm these results in the coming months.”

The clinical study was carried out in partnership with Colmar Civil Hospitals between June and December 2010. The study was carried out on 108 samples that included 32 healthy volunteers, 58 people with Alzheimer’s disease, and 18 people with multiple sclerosis.

Patient inclusion criteria were as follows:

- the healthy volunteers to be roughly the same age as the patients with Alzheimer’s disease, and should not present any psychiatric case history nor be under any medication that might negatively affect their cognitive functions,

- the patients with Alzheimer’s disease at the Alsace Consultation Mémoire de Ressource et de Recherche (CM2R) Unit of Colmar Civil Hospitals Unit that deals with research into Alzheimer’s disease are to demonstrate a likelihood of a diagnosis of Alzheimer’s disease in accordance with NINCDS-ADRDA (McKhann G, 1984) criteria based on a clinical examination, medical imaging examination and neuro-psychological tests.

- Patients with at least a chronic inflammatory syndrome such as multiple sclerosis are diagnosed on the basis of clinical, biological (analysis of cerebrospinal fluid) and medical imaging (IRM)

Alzheimer’s disease

Alzheimer’s disease is one of the major public health issues to have been identified as a national priority in a number of countries, eminent among them France, which has implemented the Alzheimer plan (2008-2012). Alzheimer’s disease is the most common cause of senile dementia, with a prevalence of the pathology of 25% of people over the age of 65. The situation is all the more worrying given that up to now no curative treatment has been available, even as the number of patients with the disease increases year on year.

- 35.6 million people worldwide have Alzheimer’s disease, a figure which is predicted to increase to 115.4 people by 2050 (World Alzheimer Report 2010, Alzheimer’s disease International).

- 2 million new cases a year of the disease are being identified in North America and Europe, where 15 million people suffer from the pathology. Over the next 20 years, this figure is expected to double.

- Given that populations in emerging countries are increasingly living a more westernised lifestyle, this number is already increased threefold.

About Innovative Health Diagnostics (IHD)

IHD was created in October 2008 in Strasbourg by Xavier Regnaut, Dr Jean de Barry and Dr François Sellal. The company is dedicated to developing diagnostic tests for Alzheimer’s disease and neurodegenerative diseases. The French National Centre for Scientific Research the CNRS granted IHD two exclusive world licences for their patents portfolio which now number 5. IHD participates in the European research programme PharmaCOG. IHD is presently developing two complementary blood tests: a specific test the IHD-Amy and a sensitive test the IHD-PKC developed in vivo on animal models for Alzheimer’s disease.

The markets being targeted by IHD are primarily the pre-clinical and clinical development of therapeutic agents, also the therapeutic monitoring of patients, and the initial diagnosis and screening of the disease. These represent a market in the order of 2 billion dollars by 2020 across Europe, Japan, Israel, Australia and North America.

IHD has been awarded a number of prizes, including: the Prize for Medical Research in November 2008, and the prize, twice over, from the Association France Alzheimer 67 and 68 in December 2008 and 2009. Dr Jean de Barry and his laboratory were awarded the trophy of the French National Industrial Property Institute INPI in recognition of their research work in industry in October 2009. Xavier Regnaut was the winner of the Mercures HEC entrepreneurial prize in 2010.

The company is supported by the following bodies: OSEO (the organisation that supports French SMEs), the Alsace region via its “Gradient” funds and its Regional Initial financing Funds initiative, also the European Fund for Economic and Regional Development (Feder), Sodiv Alsace, and business angels. To date, the company works with about ten partners. For further information go to: www.ihdiag.com

Press Contacts

IHD

Xavier Regnault

Tel : + 33 (3)88 456 676

xavier.regnaut@ihdiag.com 

ALIZE RP

Caroline Carmagnol and Anne-Sophie Cosquéric

33 (1) 42 68 86 43 / 41

caroline@alizerp.com / anne-sophie@alizerp.com