Our newest research-advisor Prof. Randall J. Bateman, MD.
C2N Update 2
Pat & Dennis Bender Early Dementia Diagnosis & Prognosis Fund
J. Dennis Bender
Office, Home & Cell Phone: 859-391-5226
5726 La Jolla Blvd. – Suite 311
La Jolla, CA 92037-7345
&
Office - 100 Riverside Pl. - Suite 303
Covington, KY 41011-5711
We support the development of improved diagnostic methods for the early detection and diagnosis of MCI, Alzheimer’s, vascular and other dementias, their likely prognosis, and best treatment. We focus on the development of Bayesian-based medical-decision-support systems, comparative-effectiveness research, and the better utilization of these for the above. (After incorporating in KY as a 501(c)(3) in 2002, we dissolved that entity for a simplified form of two entirely self-financed, private philanthropies utilizing a Vanguard Charitable Trust for making annual-research-grants for early-dementia-detection and its correct differential-diagnosis and likely-prognosis. They will continue on, after I am gone, either mentally or physically. Prof. Randall Bateman is the first of our fund’s research advisors.
See: https://www.alz.org/alzheimers-dementia/research_progress/earlier-diagnosis )
www.JDBender.com – EMS/eVTOL Experimental Aviation Fund (Vanguard Charitable Trust)
www.JDBender.org – Dementia Diagnosis Fund (Vanguard Charitable Trust)
(Images taken by J.D. Bender with my iPhone’s camera.*)
“Currently available diagnostic-tools in primary-care are not adequate. . . The Precivity-related BBM showed robust discrimination between amyloid-positive and amyloid-negative patients using CSF or PET biomarkers as the reference tests. In particular, the area-under-the-curve (AUC) [accuracy] of 0.91 (95% CI 0.88-0.94) for p-tau217-Ratio and AUC of 0.94 (95% CI 0.92-0.97) for the APS2 result were noted. Furthermore, the investigators’ work showed that primary-care-physicians (PCPs) without use of the blood-test diagnosed only 60% of symptomatic-AD correctly, leading to overdiagnosis in 23% and underdiagnosis in 17% of patients. . . An elevated value for the p-tau217-ratio (an integral component of the PrecivityAD2 blood-test) was the best biomarker for predicting-cognitive-decline. . . An ideal-blood-biomarker. . . as the need for detection and accurate diagnosis will be amplified,” [as we see the first of a couple of possible MCI and early-AD treatments come into use to slow the progress of this menace.]
C2N’s Precivity-AD2 test is an important step towards accomplishing what we have been trying to do for the past two-decades. This, along with the similar work at ALZpath, show great promise for finally accomplishing our longterm-goal of earlier detection of developing dementia and prediction as to its most-likely type.
Currently, my healthcare folks here in La Jolla keep refusing my multiple requests for a tau and amyloid PET-scan, for which I am perfectly-willing to pay the full $6,000+ cost, while waiting for the U.S. to finally approve C2N’s Precivity-AD2 blood-test for tau or similar, in addition to the C2N one already approved for amyloid-ratio that I utilized when it was first developed a few years ago. This is especially infuriating given that I helped finance the original development of PiB at the U. of Pittsburgh for the very-first amyloid-PET-scans in 2002 and later served as a volunteer test-subject for the FDA’s approval of the 18F commericalized vervions; today’s florbetapir and flortaucipir, etc.
After years of attempting to get researchers interested in this topic of early-dementia-detection with offering $50,000 research grants, I determined to build-up my grant endowment fund for aiding with this sort of research to the point where I could have a much-more-significant impact on early-and-proper-dementia-diagnosis, after my initial grant of $50,000 to the U. of Pittsburgh back in 2002 to help with their development of PiB. Back then and even still today, most just scoffed at that whole idea of having an early-dementia-diagnostic for something for which there was no treatment.
Having since built-up my Vanuard Trust dementia research endowment fund, dedicated to this specific purpose, to my funding goal of $10M, plus $2M for EMS-related aviation projects, we are now within sight of accomplishing the first of its longterm goals of better, less-expensive and much-earlier, dementia-diagnostics. We might even have gotten almost to the point where eVTOLs might eventually become a viable option for more-cost-effective EMS and related operations after two previous projects with developing a flying-dunebuggy for the Amazon and a medivac-modified gyrocopter project for the Navajo Nation. The newest potential project being with the S.D. Air & Space Museum at Gillespie Field to inspire youth in a career in aviation with eVTOL ground-school and demo rides, etc.
Here is some of the current excellent diagnostic news, in addition to finally having a couple of treatment possibilities for at least slowing the course of this devistating AD disorder.
*Having been recently sued for copyright-infringement by some copyright-trolls, after sharing freely-available images and data from the Internet in my research notes published on my two charitable websites, I am now having to use my own images until I can figure-out how to share openly-available information and images in a way so as to avoid future such lawsuits. Most academic research is available under Creative Commons rules, but the problem is with popular-press coverage of that research that I also include, along with the referenced research, plus my notes and my own weird annotation, with full credit always given to the original publisher and never of any commercial interest to myself, since I operate as a purely not-for-profit, private, charitable fund that makes research grants and has no sources of income, other than my personal investment portfolio. I believe that my current copyright-litigation is actually a harassment brought on by an organization that I criticized but who could not sue me directly, since everything I said about them was true and well documented, so they chose this indirect form of harassment to force me to hide my commentary about them from public view under an ‘Archive’ tab on my website that requires a password to access it. They have temporarly defeated my intent of making this information freely available to the interested public, but this is not the end of it.
C₂N Diagnostics’ Precivity-Related Blood Biomarkers Shown to Improve Diagnostic Accuracy and Future Risk Prediction of Alzheimer’s-Disease in Two Studies Presented at AD/PD 2023
PrecivityAD2 Blood-Test Matches-Up in Amyloid Detection to CSF Testing and Amyloid PET in Real-World Study of Patients With Cognitive-Impairment Presenting to Primary-Care
Precivity-Related Blood Biomarkers Have High-Accuracy in the Cognitively-Unimpaired Population
C2N Diagnostics, a leader in advanced brain-health diagnostics, announced the presentation of two research studies at the AD/PD 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders that bolster the role of the Precivity-related-blood-biomarkers (BBM) to help healthcare providers determine the presence or absence of amyloid-plaques-in-the-brain, a hallmark sign of Alzheimer’s-disease (AD). These findings underscore the ability of the Precivity-related-BBM to help clinicians with the diagnosis of AD in cognitively-impaired patients as well as risk-prediction in unimpaired-individuals. [Also, our own objective over the past two-decades!]
Precivityad2 Blood-test Shows Robust Accuracy in Real-World Study Dr. Sebastian Palmqvist and Dr. Oskar Hansson, Neurologists with Skåne University Hospital and Lund University in Sweden, used the PrecivityAD2 blood-test (research-use-only for now) that relies on precise mass-spectrometry-based measurements of two key plasma proteins (p-tau and amyloid-beta) implicated in AD. The blood-test reports out plasma-p-tau217-ratio (phospho-Tau217/non-phospho-tau217) and plasma Aβ42/40-ratio measures as well as the Amyloid-Probability-Score-2 (APS2) derived from a pre-established-regression-model based on those ratio-measures. The APS2 results determine whether a patient is positive or negative for brain-amyloid-plaques based on a binary-cutoff-value. [Our approach differs in that it is based on a Bayesian-decision-theoretic approach versus a simple binary outcome measure; i.e., we estimate the probability of each of the common dementias, as well as the probability of not having dementia.]
The study included 307-patients (average-age of 76-years-old) with symptoms-of-cognitive-impairment evaluated within primary-care sites in Sweden. All patients received the PrecivityAD2-blood-test as well as cerebrospinal-fluid-(CSF)-analysis or an amyloid-positron-emission-tomography (PET) scan. The Precivity-related BBM showed robust discrimination between amyloid-positive and amyloid-negative patients using CSF or PET biomarkers as the reference tests. In particular, the AUC of 0.91 (95% CI 0.88-0.94) for p-tau217-Ratio and AUC of 0.94 (95% CI 0.92-0.97) for the APS2 result were noted. Furthermore, the investigators’ work showed that primary-care physicians (PCPs) without use of the blood-test diagnosed only 60% of symptomatic-AD correctly, leading to overdiagnosis in 23% and underdiagnosis in 17% of patients.
Dr. Palmqvist says, “The primary-care physicians’ diagnosis-certainty with standard-of-care only was low, which highlights that they are completely aware that currently available diagnostic-tools in primary-care are not adequate. The results we’ve seen so far indicate that this can radically change with a blood-test-for-AD. The blood-biomarkers showed robust-clinical-validity and accuracy among patients with comorbidities known to interfere with the performance of plasma. The PrecivityAD2 data represent the highest-correlation-data I’ve seen for a blood-test against corresponding CSF-biomarkers.”
Precivity-Related BBM Accurately Identify Amyloid Pathology And Predict Clinical Decline In Cognitively Unimpaired Individuals In a separate study, Karly Cody, a Ph.D. Candidate at the University of Wisconsin-Madison Alzheimer’s Disease Research Center, found that in a cognitively-unimpaired-population of 281-individuals, the PrecivityAD2-blood-test with the APS2-score had the highest-diagnostic-accuracy (AUC~96%) for detecting brain-amyloid among other BBM studied alone or in combination.
As an extension of this study, 291-cognitively-unimpaired-individuals (average-age-59) received blood-tests and longitudinal-cognitive-follow-up (mean 8.2-years) to examine the associations of plasma-biomarkers with cognitive-status over-time. When compared against the other individual-biomarkers, an elevated value for the p-tau217-ratio (an integral component of the PrecivityAD2 blood-test) was the best biomarker for predicting-cognitive-decline.
“We congratulate our collaborators from Skåne University Hospital, Lund University and University of Wisconsin for their outstanding work to further validate C₂N’s blood-tests in a variety of important clinical applications. These research findings add to the quality and number of Precivity-related biomarker-measures we have reported through peer-reviewed publications, which now stands at approximately 10,000,” says Dr. Joel Braunstein, CEO of C₂N Diagnostics. “Both studies reinforce the perspective of the 2022 Clinical Trials On Alzheimer's Disease Task Force report on the characteristics of an ideal-blood-biomarker. This means blood-biomarkers with prospectively-defined-endpoints, validation across multiple different independent cohorts, suitability for use in primary-care, and the ability to help-with-both-diagnosis-and-risk-prediction. In particular, Dr. Palmqvist’s work highlights that as AD-specific-treatments are approved and become widely-accessible, the need for detection and accurate diagnosis will be amplified.”
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About C₂N Diagnostics, LLC C₂N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C₂N strives to provide exceptional laboratory services and products in the field of brain health. C₂N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical-decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical-trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation and Alzheimer’s Association. For more information visit www.C2N.com.
Company Contact: Joni Henderson, Director of Marketing, Outreach and Strategic Growth, C2N Diagnostics,
[Keywords and compound-keywords (tags) are highlighted-and-hyphenated in italic-and-bold; place-names, organizations and titles are in bold; media-names put in italic. Instead of underlining, I’ve been experimenting with hyphenating entire phrases – long-tail-keywords. This odd style was being tried to enhance generative-AI processing and ease-of-spotting items-of-interest in my specific website-achieved documents. Now experimenting with generative-AI to eliminate this time-consuming distraction.]
{C2N Update 2}
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