The Need For Fda Approval
Some concerns stem from the fact that the company has not obtained Food and Drug Administration approval. However, Holtzman says that CN Diagnostics is in the process of obtaining FDA approval for PrecivityAD.
It takes a lot longer to get FDA approval for anything so we started going through that process at least a year ago, says Holtzman. The company is confident that the test is very good and accurate and so we thought it would be valuable to make it available to patients if they want that information.
Midlife Alzheimers Blood Test Could Help Prove Future Predictions Wrong
In the study, 2,284 men and women with an average age of 59 were tracked for 25 years. Blood samples were analyzed at the start and then again in late life, when they were about 77. The participants did not have problems with memory or thinking skills at the outset.
Mental tests showed 502 and 832 went on to develop dementia and MCI, respectively.
The study, published in the journal Neurology, took into account age, education and cardiovascular risk factors.
As the brain engages in daily tasks, it continually produces and clears away amyloid beta, which can stop brain cells functioning properly. Some is washed into the blood, and some floats in the cerebrospinal fluid, which is why spinal taps are used. If the protein starts building up, it can collect into plaques that stick to neurons, triggering permanent damage.
They are composed mainly of amyloid beta 42, meaning it is probably being deposited in the brain before moving into the blood.
In the U.S., about 6 million people are currently living with Alzheimers. Its believed that number will balloon to 13 million by 2050, according to the Alzheimers Association. One recent study predicts that dementia cases worldwide will triple by that year.
South West News Service writer Mark Waghorn contributed to this report.
See The Hunt For A Blood Test For Alzheimers Disease
The C2N test relies on the ratio of two isoforms of the amyloid- protein, A42 and A40, that aggregate to form amyloid plaques in the brain, combined with the presence of isoforms of apolipoprotein E that reflect whether the patient caries a genetic variant associated with Alzheimers risk. The results are combined into a score that indicates the probability that a patient would be found to have amyloid plaques if they were to undergo an amyloid PET scan. Doctors can then consider the test results along with other information about the patient to arrive at a diagnosis. According to data posted on the companys website, a study in 686 patients with cognitive impairment found that those with scores above a certain cutoff point had a positive amyloid PET scan 92 percent of the time, while those with scores below a certain cutoff had a 77 percent chance of having a negative result on the PET scan.
While no drugs have yet been approved to treat Alzheimers, being able to distinguish it from other possible causes of cognitive impairment is nonetheless valuable, Fillit and Schindler say. As a clinician, Schindler says, I want to know what my patients have. That can be complicated because in many cases, they dont just have memory impairment, theyre taking multiple medications, they have all sorts of health issues, she says. And sometimes its really hard to know whether the symptoms theyre experiencing are due to something like Alzheimers or something else.
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Added Benefits Of The Blood Test
MRIs and other Alzheimers diagnostic tests can be pricey. This test can improve diagnostic accuracy in an inexpensive way, Szigeti says. She adds it may also help bring peace of mind to people who are worried that they may be developing Alzheimers disease, but are actually experiencing symptoms due to another health issue.
The blood test may also help identify people who qualify for clinical trials.
“Those trials use medications that we are hoping will stop the progression of the disease, and may be more helpful for certain patients, Szigeti says.
Ultimately, the test may be more helpful with time as new treatments are developed.
With an increasing focus on prevention in developing new medications, the potential for intervening early will become very important over the next years, Paul Newhouse, MD, director of the Vanderbilt Center for Cognitive Medicine, tells Verywell. “We have been searching for some time for blood tests that would help us confirm the diagnosis of Alzheimer’s disease. If these results are confirmed, this could be a very promising new diagnostic test that would help us diagnose patients earlier than we are able to now.”
With Alzheimers Disease Prevention Is Key
There are many ways to diagnose Alzheimers, although a definitive diagnosis cannot be achieved except in an autopsy, where brain tissue can be precisely examined. Typically, doctors use various tests to rule out conditions that could explain dementia-like symptoms.
Patients diagnosed with Alzheimers disease live another 4-8 years, on average, after their diagnosis.
However, you dont have to sit back and wait for Alzheimers to take its toll. Some patients live up to 20 years after their diagnosis!
Because most if not all conventional dementia treatments have about a 1% chance of success, the need for a revolutionary new approach is critical for treating dementia and Alzheimers.
At PrimeHealth, Dr. David Ward hosts an Alzheimers Prevention Program incorporating Dr. Dale Bredesens revolutionary, evidence-based lifestyle approach to optimize cognitive function. Schedule an appointment with us and learn more about PrimeHealths Prevention Program.
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Minimally Invasive Blood Test For Alzheimers Disease Announced
- News and media
- Minimally invasive blood test for Alzheimers disease announced
Scientists from Japan and Australia have teamed up to develop and validate a blood test for Alzheimers disease, with the potential to massively ramp up the pace of Alzheimers disease drug trials.
The blood test measures a specific peptide in the blood to inform scientists, with 90 per cent accuracy, if a patient has the very earliest stages of Alzheimers disease.
Blood samples from patients in a large study from the Japanese National Center for Geriatrics and Gerontology were initially analysed to identify the relevant peptides. Those indicating brain beta-amyloid burden were then tested against patient samples from the Australian Imaging, Biomarker and Lifestyle Study of Aging , to validate the results.
Professor Katsuhiko Yanagisawa, Director-general of Research Institute at NCGG, says: Our study demonstrates the high accuracy, reliability and reproducibility of this blood test, as it was successfully validated in two independent large datasets from Japan and Australia.
Dr Koichi Tanaka at Shimadzu Corporation was instrumental in developing the initial blood testing procedure. Professor Tanaka won the Nobel prize in Chemistry in 2002 for the technique. From a tiny blood sample, our method can measure several amyloid-related proteins, even though their concentration is extremely low. We found that the ratio of these proteins was an accurate surrogate for brain amyloid burden.
Blood Tests Available Now
A blood test is available now, through your doctor, that delivers a result in about 10 days and accurately determines whether someone has Alzheimers disease. The Preclivity AD Test from C2N Diagnostics measures proteins in blood plasma that indicate a buildup of plaques known to cause dementia in peoples brains.
Cost
The cost of this Alzheimers blood test is $1,250, less expensive than a PET scan that looks for the same protein buildups. Unfortunately, the price tag cannot be covered by Medicare or Medicaid, but C2N says people who cant afford the test can qualify for a discount based on their income.
Does it Work?
C2N Diagnostics says they tested Preclivity AD in 686 people and compared it to the results of PET scans. When PET scans showed a high amount of amyloid-beta, a protein that turns to plaques and tangles in the brains of people with Alzheimers, the blood test agreed 92 percent of the time. When the PET scan showed no amyloid, the blood test showed the same about 77 percent of the time.
How to Get the Blood Test
The Preclivity AD Test has not been approved by the Food and Drug Administration. It is currently available only through a doctor, and can be sold by the company under rules for commercial laboratories. The test, in other words, is available despite lacking FDA approval, though C2N has said the FDA is planning on reviewing the test in 2021. The Alzheimers Association says it wont endorse the test until there is FDA approval.
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Alzheimers Blood Tests Available In The Future
Another test thats shown promise is called the Simoa that also tests for proteins in blood plasma. Its the same idea as other blood tests: identify biomarkers in the blood that can usually only be seen via expensive or difficult exams including PET brain scans, MRIs, and spinal taps. The specific protein Simoa can detect is called ptau181, and has been linked to the changes caused by dementia in the brain.
In studies, the Simoa was found to be as good at predicting the development of dementia as PET scans and a spinal tap, without the cost, pain, or radioactivity associated with those tests. And the test can also detect upcoming dementia-caused brain changes in both the short and longer terms. Right now, this technology is used by researchers to identify people who are good candidates for clinical trials. It is not yet available for most patients.
Scientists Develop Simple Blood Test For Early Detection Of Alzheimer’s Disease
- Date:
- Hong Kong University of Science and Technology
- Summary:
- An international research team has developed a simple but robust blood test from Chinese patient data for early detection and screening of Alzheimer’s disease with an accuracy level of over 96%.
An international research team led by HKUST has developed a simple but robust blood test from Chinese patient data for early detection and screening of Alzheimer’s disease for the first time, with an accuracy level of over 96%.
Currently, doctors mainly rely on cognitive tests to diagnose a person with AD. Besides clinical assessment, brain imaging and lumbar puncture are the two most commonly used medical procedures to detect changes in the brain caused by AD. However, these methods are expensive, invasive, and frequently unavailable in many countries.
“With the advancement of ultrasensitive blood-based protein detection technology, we have developed a simple, noninvasive, and accurate diagnostic solution for AD, which will greatly facilitate population-scale screening and staging of the disease,” said Prof. Nancy Ip, Morningside Professor of Life Science and the Director of the State Key Laboratory of Molecular Neuroscience at HKUST.
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Some Of The Commonly Used Cognitive Tests Include:
Mini-Mental Status Examination
This test is usually conducted by your doctor or specialist in their office and takes around 5 minutes to complete. The MMSE is the most common test for the screening of dementia. It assesses skills such as reading, writing, orientation and short-term memory.
Alzheimers Disease Assessment Scale-Cognitive
This 11-part test is more thorough than the MMSE and can be used for people with mild symptoms.
It is considered the best brief examination for memory and language skills.
It takes around 30 minutes and is usually conducted by a specialist in their office, or you may be referred to a psychologist for the test.
Neuropsychological Testing
This involves a number of very sensitive tests administered by a neuropsychologist .
A typical testing session will take at least 2 hours and may be conducted over more than one visit.
A variety of tests will be used and may include tests of memory such as recall of a paragraph, tests of the ability to copy drawings or figures and tests of reasoning and comprehension.
Radiological tests
Standard X-rays may be taken and those who smoke will commonly require a chest X-ray to rule out lung cancer, which may be causing a secondary brain tumour. \
Brain imaging techniques
Various brain-imaging techniques are sometimes used to show brain changes and to rule out other conditions such as tumour, infarcts and hydrocephalus these include:
Elevated Levels Detected Long Before Symptoms Appeared
The disease is a consequence of high levels of amyloid and tau proteins in the brain.
The researchers took blood samples from 1,100 Swedish inhabitants over a number of years. They used their test to measure the presence of phosphorylated tau protein .
They then compared these blood tests with individuals who were subsequently diagnosed with Alzheimer’s.
The test revealed a strong link between elevated levels of this specific tau protein in the blood and the loss of nerve cells and impaired cognitive ability in Alzheimer’s disease several years later.
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Investigational Alzheimers Blood Test Reports 96% Accuracy
Using the blue device that performs the ultrasensitive proximity extension assay technology, Professor Nancy Ip Yuk-Yu and her team have developed a blood test for early detection and screening of Alzheimers from Chinese patient data, with an accuracy level of over 96 percent. Image courtesy of the Hong Kong University of Science and Technology.
What Happens If A Doctor Thinks It’s Alzheimer’s Disease
If a primary care doctor suspects mild cognitive impairment or possible Alzheimers, he or she may refer the patient to a specialist who can provide a detailed diagnosis or further assessment. Specialists include:
- Geriatricians, who manage health care in older adults and know how the body changes as it ages and whether symptoms indicate a serious problem
- Geriatric psychiatrists, who specialize in the mental and emotional problems of older adults and can assess memory and thinking problems
- Neurologists, who specialize in abnormalities of the brain and central nervous system and can conduct and review brain scans
- Neuropsychologists, who can conduct tests of memory and thinking
Memory clinics and centers, including Alzheimers Disease Research Centers, offer teams of specialists who work together to diagnose the problem. Tests often are done at the clinic or center, which can speed up diagnosis.
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Why Is Early Diagnosis Important
For people with Alzheimers, neuropathological changes start to accumulate in the brain 10 to 20 years before the first clinical sign of dementia. Although early intervention in the disease would greatly improve disease prognosis, the current tribulations involved in accurate early diagnoses means that many patients miss the golden period for therapeutic intervention or disease management, resulting in poor outcomes.
An early diagnosis also increases ones eligibility for a wider variety of clinical trials, which contribute to research and involve regular monitoring from doctors.
A New Target And An Exciting Test Emerges
For years, efforts to find such an easily obtainable Alzheimers diagnostic biomarker in the blood came up emptythey were not accurate enough.
A major reason for inconsistency of the prior reports was the extremely small amounts of these protein fragments in the blood. The tests have to be sensitive enough to detect either amyloid or tau, and be accurate enough that the blood level changes occurring in people with Alzheimers can be clearly different from those of non-affected people.
Now, several publications and presentations at the recent Alzheimers Association International Conference have demonstrated that blood tests measuring amyloid and tau proteins have become much more sensitive and accurate enough to allow their possible future use as routine aids in Alzheimers disease diagnosis.
These various tests are at different stages of validationassuring theyre accurate across many different patient populations. And, for each protein, there are several different methods for making the blood measurements. However, the research community is excited about the possibilities.
And one new tau blood test appears to meet a number of criteria necessary.
To be useful, the tests have to be nearly perfect predictors. Many arent there yet so far, they seem to get it right up to over 85% of the time. And the accuracy will be very important if theyre to be used to screen people for positive tests and enter those people into clinical trials.
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Can The Mindcrowd Test Be Used To Figure Out If A Medical Consultation Is Needed
No. This is not a diagnostic test. MindCrowd is a research test, and its not designed to diagnose Alzheimers.
Dont be afraid to take it, even if you find it difficult, because it doesnt mean you have dementia or even mild cognitive decline. But you are helping scientists learn more about how the brain ages.
Alzheimers diagnostic testing looks at many aspects of how your brain works and the MindCrowd test is only looking at two particular areas: Attention and Memory.
Detecting Alzheimers Gets Easier With A Simple Blood Test
New assays could reduce the need for costlier, more invasive brain scans and spinal fluid measures
When a patient complains of forgetfulness, a neurologist might not know immediately whether it results from normal aging, reduced blood flow to the brainor, more ominously, Alzheimers disease. For much of the past century, a definitive Alzheimers diagnosis could only be made during an autopsy. Brain imaging and spinal fluid tests now make it possible to spot the disease in patients even before the initial symptoms appear. But these invasive tests are expensive and generally limited to research settings that are not part of routine care for the millions of people suffering from the most common neurodegenerative disorder.
An era in which an Alzheimers diagnosis can begin in a doctors office is now arriving. Advances in technologies to detect early signs of disease from a blood sample are helping doctors to identify the memory-robbing disorder more accurately and to screen participants more quickly for trials of potential treatments for the more than five million people in the U.S. afflicted with Alzheimers.
The development of a blood-based test for Alzheimers disease is just phenomenal, says Michelle Mielke, a neuroscientist and epidemiologist at the Mayo Clinic. The field has been thinking about this for a very long time. Its really been in the last couple of years that the possibility has come to fruition.
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