A new Alzheimer’s blood test recently approved by the U. S. Food and Drug Administration (FDA) can now detect the disease in people with early stages of the illness. The research that led to the finding was published in Friday’s edition of Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association.
Highly Accurate
“Our study found that blood testing affirmed the diagnosis of Alzheimer’s disease with 95% sensitivity and 82% specificity,” says corresponding author Gregg Day, M.D., a Mayo Clinic neurologist, dementia specialist, and clinical researcher.
In other words, the tests detected Alzheimer’s 95% of the time and ruled out people who did not have dementia 82 percent of the time.
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
FDA Fast Tracked Approval
The way blood is tested for Alzheimer’s disease is through use of the Lumipulse G p Tau217/B-Amyloid Plasma Ratio. That measures the concentration of pTau217, which is a tau protein that forms tangles in the brain. It also measures B-Amyloid 1-42, which is a significant component of amyloid plaque in the blood. The ratio of those proteins is measured against any amyloid plaques in the brain to make a diagnosis.
The FDA cleared the blood test for quick use by designating it a Breakthrough Device. That means its development, review, and approval were expedited.
Less Expensive and Less Invasive
Methods for diagnosing Alzheimer’s Disease in its early stages have been expensive and invasive.
Standard diagnostic measures usually start with a review of family history and cognitive and functional examinations. Those steps are relatively inexpensive and non-invasive. However, more detailed testing may include positron emission tomography (PET) or brain scans and spinal taps.
The new Alzheimer’s testing is simply a blood draw. There is no need for extracting spinal fluid or imaging.
“When performed in the outpatient clinical setting, this is similar to the accuracy of cerebrospinal fluid biomarkers of the disease and is much more convenient and cost-effective,” said Day.
Cerebrospinal fluid biomarkers are proteins, peptides, and nucleic acids that can reveal diseases, particularly in the spine and brain.
How The Study Was Done
Mayo’s study was conducted at its Jacksonville, Florida, clinic. Around 500 patients who were being treated for memory disorders took part in the research. They were aged 32 to 89 years old.
The results showed that 56% were suffering from Alzheimer’s disease.
What Causes Alzheimer’s Disease
Alzheimer’s disease is an incurable brain disease. Usually, it progresses slowly over several years. However, in some individuals, it can move rapidly.
Researchers are trying to determine what causes the buildup of the protein deposits, primarily amyloid plaques and tau tangles, in the brain. However, other factors are known to contribute to the development of Alzheimer’s disease, according to the National Institute on Aging (NIA). They include:
- Genetic factors.
- Lifestyle – smoking, poor diet, lack of exercise, and pollution.
- Medical conditions – diabetes, high blood pressure, and heart disease.
- Age – The disease usually develops after 65.
- Brain injuries increase the risk of developing Alzheimer’s disease.
- Depression and social isolation.
- Obesity.
Most areas of the brain are ultimately affected by the disease. That includes memory, cognitive functions, language, problem-solving, personality, and movement.
Five Stages of Alzheimer’s
Alzheimer’s disease generally moves through five stages, according to the Mayo Clinic. The preclinical phase does not exhibit signs of the disease and is usually only found through testing. This stage can last years – even decades.
Symptoms, such as slight memory loss and short-term thinking difficulty, appear in the mild cognitive impairment (MIC) stage. From there, the decline accelerates.
People live, on average, 3 to 11 years after diagnosis, reports the Mayo Clinic. However, some have lived over 20 years. Life expectancy is affected by how early a diagnosis is made, as well as the presence or absence of untreated vascular diseases such as high blood pressure.
Diagnosis – Not A Cure
The new Alzheimer’s blood test is a milestone for researchers and patients. However, it is not a cure.
“Today marks another important step in Alzheimer’s disease diagnosis,” said Maria C. Carrillo, Ph.D., when the test was approved by the FDA. She is the Alzheimer’s Association’s chief science officer. “For too long Americans have struggled to get a simple and accurate diagnosis; with today’s action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier.”
Most people with Alzheimer’s disease experience symptoms in their mid-sixties or later, according to the National Institute on Aging. In very rare cases, signs of the disease can appear in people in their thirties.
Treatment
Early diagnosis is important to a patient’s quality of life, even though there is no cure currently.
A variety of treatments target different aspects of the disease.
Donanemab, marketed under the name Kisula, and Lecanemab, marketed as Leqembi, are two treatments for early-onset Alzheimer’s disease. They both collect and remove beta-amyloid from the brain.
While not cures, these treatments have been shown to reduce the progression of Alzheimer’s disease, according to the Alzheimer’s Association. However, there may be side effects, including amyloid-related imaging abnormalities (ARIA). That results in temporary swelling in areas of the brain.
When To See A Doctor
Since 1983, June has been Alzheimer’s and Brain Awareness Month. That makes this the perfect time to focus on brain health.
You should consider talking to a doctor if you or a loved one is constantly having problems with memory, performing routine tasks, or thinking clearly.
The Alzheimer’s Association has created 10 early signs and symptoms of Alzheimer’s and dementia. They include:
- Memory loss that disrupts daily life.
- Challenges in planning or solving problems.
- Difficulty in completing familiar tasks.
- Confusion with time or place.
- Trouble understanding visual images and spatial relationships.
- New problems with words in speaking or writing.
- Misplacing things and losing the ability to retrace steps.
- Decreased or poor judgment.
- Withdrawal from work or social activities.
- Changes in mood or personality.
Other Sources Of Help
There are many resources available to help individuals and families dealing with Alzheimer’s disease.
The Alzheimer’s Association provides the following links:
- How is Alzheimer’s Disease Diagnosed?
- Communicating with Your Health Care Team (PDF)
- 10 Warning Signs Worksheet (PDF)
- 10 Warning Signs of Alzheimer’s (free online course)
- 10 Steps to Approach Memory Concerns in Others (PDF)
- 10 Steps to Approach Memory Concerns in Yourself (PDF)
- Why Get Checked?
The NIA lists these resources:
NIA Alzheimer’s and Related Dementias Education and Referral (ADEAR) Center
800-438-4380
[email protected]
www.nia.nih.gov/alzheimers
This center provides free information, including print publications about Alzheimer’s and related dementias for families, caregivers, and health professionals. ADEAR Center staff answer telephone, email, and written requests and make referrals to local and national resources.
Alzheimers.gov
www.alzheimers.gov
Information about Alzheimer’s and dementia is provided here from all federal agencies.
Eldercare Locator
800-677-1116
[email protected]
https://eldercare.acl.gov
MedlinePlus
National Library of Medicine
www.medlineplus.gov
Alzheimer’s Association
800-272-3900
866-403-3073 (TTY)
[email protected]
www.alz.org
Alzheimer’s Foundation of America
866-232-8484
[email protected]
www.alzfdn.org
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