By Howard Fillit & George Vradenburg
January 28, 2021 at 5:00 am ET
With the U.S. Food and Drug Administration set by early March to decide on the approval of aducanumab, the first disease-modifying therapy for Alzheimer’s to be considered by the FDA in nearly 20 years, technologies are advancing in the Alzheimer’s space that would greatly advance the application of drugs like aducanumab by connecting patients newly and accurately screened for Alzheimer’s disease risk with a potential therapeutic solution.
This opportunity could not come at a better time. Last year, a remarkable story was published that highlighted the latest research on the accuracy of blood tests to help physicians provide diagnoses for those living with or at risk for Alzheimer’s disease. These tests, the article noted, would be available in the next two or three years.
But the pace of progress is moving even faster than anticipated. C2N Diagnostics announced the introduction of the first blood-based biomarker diagnostic test, PrecivityAD, which reliably and accurately predicts the presence or absence of brain amyloid, an essential and early marker of Alzheimer’s.
PrecivityAD is but one of a number of blood-based diagnostics being investigated by numerous companies and research centers in the quest to create accessible, affordable and familiar diagnostic tools for patients. There are three primary reasons why these diagnostics are the future of game-changing early intervention for preventing and effectively treating Alzheimer’s.
First, a simple blood test – which we all take to check our cholesterol for risk of heart disease or to check our A1C for risk of diabetes – is easy to use and well-understood by doctors and patients. It is also more affordable than current options. Current diagnostic aids – PET scans and spinal taps – are expensive and invasive, and not in the day-to-day arsenal of tools typically used by primary care physicians or patients.
Imagine, then, if patients and their doctors were able to get a blood test that detected Alzheimer’s risk. Those who find themselves at risk, in consultation with their physicians, could then plan the lifestyle changes and medical management of their other health conditions, such as hypertension, diabetes and obesity, known to increase their risk of future dementia symptoms.
Indeed, a report from the Lancet medical journal indicates that up to 40 percent of dementia cases could be prevented through management of a series of 12 modifiable risk factors, including diet, exercise, smoking, excess alcohol consumption, hypertension, diabetes, sleep disorders and others.
Separately, the availability of promising disease-modifying treatments now before the FDA for approval or in late-stage trials will be dependent on widespread availability of inexpensive and easy-to-obtain blood tests which can inform a doctor’s determination of a patient’s suitability for the treatment. Waiting for a neurologist’s availability to prescribe a hard-to-get brain scan will delay patient access to the benefits of these drugs. And the out-of-pocket costs of a scan will put promising therapies out of reach for most Americans.
Second, blood tests, as compared to current testing methods (e.g., brain scans), could be prescribed and administered by a local nurse or family doctor rather than a harder-to-find neurologist or hospital-based specialist. These factors improve patients’ ease of access and reduce the cost burden on the health care system, as well as increase diagnostic access to low-income populations and demographics and ethnic groups historically underserved by the medical community.
Third, there are positive upstream impacts of blood-based tests for Alzheimer’s research as well. Clinical trials for Alzheimer’s are in desperate need of increased participation from a wide swath of income demographics and ethnicities.
Many willing recruits for those trials discover that they do not, in fact, have the toxic proteins in their brains which are the hallmarks of Alzheimer’s – but only after an expensive brain scan. These “screen failures” waste tens of millions of dollars and months of delayed processing that could be avoided with a simple blood test before being sent for a confirmatory brain scan. A soon-to-be-launched study by the Global Alzheimer’s Platform will test the performance of a wide range of blood and other novel biomarkers for use in reducing the time and costs of Alzheimer’s clinical trials.
Blood tests and blood-based biomarkers in clinical trials must be a key part of the future of early intervention for Alzheimer’s disease. They are easy to administer, cost-effective, will spur an expansion of clinical trials, provide access to drugs for low-income and underserved populations and place new information in the hands of providers that will allow them to give informed medical guidance to their patients now.
Studies have suggested there may be 46 million people in the United States with Alzheimer’s disease and at risk for developing dementia. Most of these people are undiagnosed. It is estimated that only about 6 million currently suffer dementia from Alzheimer’s, but the numbers will grow dramatically. With new advances in prevention research, the preclinical diagnosis of Alzheimer’s enabled by a simple blood test will help to get more people practicing effective preventative measures.
The tests are a new tool that can enable early intervention to effectively treat the millions of Americans living with or at risk for Alzheimer’s. As such, blood-based diagnostics will improve the physical, emotional and financial well-being of millions of patients and their families for decades to come and can reduce the enormous economic burden of Alzheimer’s disease on American society.
George Vradenburg is the co-founder and chairman of UsAgainstAlzheimer’s. Howard Fillit is the founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation and a clinical professor of geriatric medicine and palliative care, medicine and neuroscience at the Icahn School of Medicine at Mount Sinai; ADDF is a venture philanthropy and an investor in C2N Diagnostics.
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