Anavex Life Sciences Corp (AVXL)

[sokol]

My understanding is the Cognision system can easily measure ERP. There is no reason why Anavex will not do that. I suppose that Anavex may be able to submit this results as further evidence in support of an application for drug approval, but see this:

“Some scientists commented privately to Alzforum that they are unsure whether ERPs are ready for prime time as an efficacy biomarker for Alzheimer’s drug candidates, since little evidence exists yet that these signals change over time.”

https://www.alzforum.org/news/research-news/fda-has-cleared-new-cognitive-screening-tests

And this:

EVENT-RELATED POTENTIALS AND THE DIAGNOSIS OF ALZHEIMER’S DISEASE— THE COGNISION™ SYSTEM
David A Casey
US Neurology, 2010;6(2):34-36 DOI: http://doi.org/10.17925/USN.2010.06.02.34
Abstract: Alzheimer’s disease is a major cause of cognitive decline among older people. Current diagnostic approaches rely primarily on cognitive symptoms. Recently proposed changes in the definition of the disease place more emphasis on the use of biomarkers (such as neuroimaging or cerebrospinal fluid markers) in the hope of allowing earlier and more definitive diagnosis for research and, eventually, clinical purposes. Event-related potentials (ERP) represent another promising biomarker approach. Alzheimer’s disease has been demonstrated to have a recognizable ERP signature. Recent advances in ERP technology may make the process painless, non-invasive and portable. These advantages suggest that ERP should be further considered as a potential biomarker for Alzheimer’s disease.

Support: The publication of this article was funded by Neuronetrix Solutions. The views and opinions expressed are those of the author and not necessarily those of Neuronetrix Solutions.
Keywords: Alzheimer's, event-related potentials (ERP), bio-marker, COGNISION™
Disclosure: David A Casey, MD, is on the scientific advisory board of Neuronetrix Solutions.
Received: September 27, 2010 Accepted: November 29, 2010
Correspondence: David A Casey, MD, Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, 401 E Chestnut St, Suite 610, Louisville, KY 40202. E: [e-mail]


Alzheimer’s disease (AD) is a major source of disability and mortality among older people. AD prevalence is rapidly increasing with increasing lifespan and a larger absolute number of elders. Current treatments, such as cholinesterase inhibitors or N-methyl-D-aspartic acid antagonists are supportive or palliative in nature, and are based on optimizing neurotransmission, but do not alter the underlying disease process. Their effects are modest and not every patient responds positively. In recent years enormous efforts have been under way to improve understanding of the disease and develop improved treatments. This article examines new developments in the definition of the disease and the growing importance of biomarkers in diagnosis. It will focus on the possible use of event-related potentials (ERP), an electrophysiological parameter, as a cognitive AD biomarker.

Clinical Diagnosis of Alzheimer’s Disease
Clinical diagnostic criteria of AD rely primarily on cognitive parameters and are based on excluding other possible causes of cognitive deficit. Such parameters include:
progressive, disabling loss of memory (especially episodic memory);
loss of other cognitive skills, such as language and executive function; and
diminishing functional ability, such as the ability to carry out activities of daily living.
In clinical practice, laboratory testing and neuroimaging serve primarily to help rule out other potential conditions. One must have substantial loss of cognition to qualify for the diagnosis of AD.1

Pathological Characterization of Alzheimer’s Disease
AD is characterized pathologically by amyloid plaques and neurofibrillary tangles, which are comprised primarily of misfolded proteins, along with atrophy. Amyloid is widely believed to be central to the pathogenesis of AD, a point of view known as the ‘amyloid hypothesis’. Plaques are believed to evolve through a complex pathway, commencing years before clinical memory symptoms of AD. Plaques and tangles cannot be visualized or detected by standard clinical imaging or laboratory techniques.2 However, amyloid plaques can be visualized with advanced positron emission tomography (PET) imaging systems utilizing labeling compounds that can currently only be used in specialized research settings (although new approaches are under development).3,4

The recent failure of several amyloid-based clinical therapeutic trials has provoked a rethinking of treatment strategies in AD. Some researchers have become skeptical of the amyloid hypothesis.5Many others believe that memory symptoms are a relatively late development in AD and that a successful therapy, including an amyloid-based strategy, depends on intervening earlier in the disease process.

A New Definition of the Disease
In order to facilitate this strategy, a new and evolving definition of AD has been created that relies on biomarkers along with progressive cognitive decline. This approach defines AD more clearly as a brain disease of plaques and tangles, rather than strictly being a cognitive disorder or dementia. The three proposed categories include:
Alzheimer’s disease dementia;
mild cognitive impairment due to Alzheimer’s disease; and
pre-clinical Alzheimer’s disease.

This definition greatly expands the number of individuals counted as having the disease by including a large group of asymptomatic people. It is hoped that redefining AD in this way will facilitate a unified research program and prompt a search for earlier interventions. Under the old definition of AD that relies on clinical diagonsis, new drug development aimed at intervention at the earliest possible stage would be greatly hampered as the industry is reluctant to expend enormous resources on a condition that is not recognized as a disease.6

https://www.touchneurology.com/articles/event-related-potentials-and-diagnosis-alzheimer-s-disease-cognision-system