The U.S. Food and Drug Administration (FDA) has green-lit a blood test that can help doctors diagnose Alzheimer’s disease, the most common form of dementia.
The test is only meant for older adults who are experiencing symptoms of Alzheimer’s disease; it is not a screening test.
“Today marks another important step in Alzheimer’s disease diagnosis,” Maria C. Carrillo, chief science officer and medical affairs lead at the Alzheimer’s Association, said in a statement.
“We’re going to have that for Alzheimer’s disease in the future.
So this is just the beginning of really going into a new age of Alzheimer’s disease diagnosis and care and clinical trials.”
The U. S. A blood test approved by the Food and Drug Administration (FDA) can assist medical professionals in diagnosing Alzheimer’s disease, the most prevalent type of dementia. More than 7 million older Americans suffer from the illness, which is characterized by a decline in memory and cognitive abilities. This is the first blood test approved by the FDA for the condition.
Amyloid plaques are aberrant protein clusters in the brain that can be found using the Lumipulse test. Alzheimer’s disease is characterized by these plaques, which impair brain cell function.
In addition to detecting amyloid plaques, PET scans and spinal fluid tests have long been used to assist medical professionals in diagnosing Alzheimer’s disease. In the case of the lumbar puncture, however, the tests are invasive and costly. Additionally, those living in rural areas may not be able to access them. When a patient is 55 years of age or older and exhibiting symptoms of the disease, Lumipulse only needs a blood sample.
“A blood test simply makes it so much easier to be able to make a diagnosis of Alzheimer’s disease,” Charles Bernick, M.D, stated. works as a neurologist at the Lou Ruvo Center for Brain Health at the Cleveland Clinic in Las Vegas.
The test’s manufacturer, Fujirebio Diagnostics, did not include the test’s price in its press release.
People shouldn’t test if they don’t have any symptoms.
According to the FDA, the recently approved blood test measures two proteins in plasma, the liquid portion of blood, and then computes the ratio of these proteins, which is “correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan.”.
The test is not intended for screening; rather, it is intended for older adults who are exhibiting signs of Alzheimer’s disease. Furthermore, the FDA stated that in order to decide on a course of treatment, the results should be combined with “other clinical evaluations or additional tests.”. Physicians frequently employ neurological examinations and cognitive tests, for instance, to diagnose a patient with Alzheimer’s disease, in addition to brain imaging and lumbar punctures. Bernick stated, “You still have to look at the whole picture when making a diagnosis.”.
Kisunla (donanemab) and Leqembi (lecanemab) are two drugs that the FDA has approved in recent years to treat Alzheimer’s disease. Despite not curing the illness, these infusion-based medications can help slow the rate of decline in patients in its early stages. The presence of amyloid must be verified before they can be prescribed because they function by removing amyloid plaques from the brain.
“They are not without risk.”. Therefore, if you plan to use them, you must be fairly certain that the individual possesses that protein in their brain, according to Bernick. Brain hemorrhage and swelling are possible risks.
A new test might “revolutionize” clinical care and research.
Blood tests that have not been approved by the FDA have already been used by some Alzheimer’s specialists to aid in the diagnosis of the condition. Laboratory-developed tests, like these blood tests, do not need FDA approval. However, receiving the agency’s approval validates the accuracy of a test and makes it possible for insurance to cover it and for it to be used more widely.
The FDA’s announcement on May 16 was praised by expert groups. Fillit, Howard, MdotD. Blood tests are “incredibly needed,” and their development will “revolutionize clinical care and clinical research” for Alzheimer’s, according to the co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation.
“It will lower the cost of care and diagnosis, and it will allow people to receive a conclusive diagnosis and enroll in clinical trials,” Fillit told AARP.
Maria C. said, “Today is another significant step in the diagnosis of Alzheimer’s disease.”. According to a statement from the Alzheimer’s Association, Carrillo is the chief science officer and medical affairs lead. Americans have battled for far too long to obtain a straightforward and precise diagnosis; we hope that today’s FDA action will make it simpler for more people to get an accurate diagnosis sooner. “”.
According to Fillit, more blood tests will be available soon, including ones that identify other important aspects of Alzheimer’s disease, like brain inflammation. As more drugs become available online, performing such tests could assist physicians in customizing a patient’s care.
According to Fillit, “it’s going to look kind of like cancer, where patients have a tumor, the tumor is biopsyed, the tumor cells are taken to the lab, and they’re characterized according to various biomarkers, and then their treatment plan is designed with various drugs in combination, and the patient receives multiple drugs affecting multiple pathways in the cancer cell.”. In the future, we will have that for Alzheimer’s disease. This marks the start of a new era in Alzheimer’s disease diagnosis, treatment, and clinical research. “.”.
