IHD blood test for Alzheimer's disease yields 83% sensitivity and 82% specificity

Innovative Health Diagnostics (IHD)Jul 18 2011

Best results obtained to date for a blood test for Alzheimer's disease with 83% sensitivity and 82% specificity;

“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.”

Results presented to ICAD (International Conference on Alzheimer's disease) in Paris on 17^th and 18^th July

Innovative Health Diagnostics (IHD), the innovative company specialising in the development of diagnostic blood tests for Alzheimer's disease and neurodegenerative illnesses presents its first clinical results for its IHD-Amy blood test for Alzheimer's disease.

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 β-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)