Another step forward in the fight against Alzheimer's disease ~ Dr. Domenico Pratico', MD, FCPP

This week the U.S. Food and Drug Administration (FDA) approved the first diagnostic device that by measuring in the blood two proteins can aid in the diagnosis of Alzheimer’s disease in adult, aged 55 years and older, already exhibiting signs and symptoms of the disease.

Similar tests were previously available but only to be used with cerebrospinal fluid samples, which are collected through an invasive lumbar puncture (aka, spinal tap). This new one requires only blood, making it less invasive and easier for patients.  

Working towards a biomarker

The announcement marks an important step forward in the fight against Alzheimer’s disease. While we all agree that there is not a single test that can diagnose the disease, including this new one, there is no doubt that adding it to the others available will be an important part of the complex diagnostic journey for many patients. 

Currently, a proper diagnosis of Alzheimer’s disease requires taking a careful medical history, complete a comprehensive cognitive and functional assessment, and importantly ruling out any other medical conditions that could cause cognitive impairment (Vit B deficits, reduced function of the thyroid gland).

After those tasks are completed, a doctor could consider brain imaging (PET/MRI scan), or a cerebrospinal fluid test. The availability of a blood test to see if there is evidence of Alzheimer's pathology in the patient’s brain, to make an accurate diagnosis and decide whether the subject is eligible to be enrolled in a clinical trial, or for an approved treatment is indeed an exciting breakthrough for the field.

How did the FDA reach this conclusion?

They reviewed the data from a multi-center clinical study of almost 500 individual plasma samples from adults who were cognitively impaired. The samples were assayed with the new test (Lumipulse G), the results obtained (pTau217/ß-Amyloid 1-42 Plasma Ratio) then compared with amyloid PET scan or CSF test results in the same individuals. In the study, almost 92% of individuals with positive results had the presence of amyloid beta plaques by PET scan or CSF test results, and almost 98 % of individuals with negative results had a negative amyloid beta PET scan or CSF test result.

These findings indicate that the new test can detect the presence of brain amyloid beta pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired. It is very important to stress that the test is currently intended only for patients presenting with signs and symptoms of cognitive decline, and that the results of the test must be always interpreted in conjunction with other patient clinical information.

A blood test to measure a biomarker for Alzheimer's disease

The test is not just a significant scientific progress, it should be considered as a milestone in the history of the disease since it brings us closer to an earlier, more definitive diagnosis of it, and at the same tome paves the way to better targeted treatment options for patients and families. Like for other medical areas such as oncology, this is the first step towards a precision and personalized medical approach but for neurology.  

The burning question is: what to do if one receives a positive test result?

There is good news. Consistent evidence indicates that lifestyle interventions can successfully decrease the progressive build-up of tau and amyloid-beta pathology in the brain of an individual. We are all familiar with the 6 pillars of brain health (socialization, physical activity, diet, sleep, brain activity, physical health) all of which (or most of which) can be easily followed by anyone. Practically this notion means that one can slow down the built up of amyloid-beta, improve cognition and significantly decrease the risk of Alzheimer’s disease onset through lifestyle changes. And importantly, by using this test one can even track the progress made after a few months.

Together, let’s celebrate this moment of breathtaking innovation in Alzheimer’s disease research. Believe it or not, we are witnessing a revolutionary moment of real hope for the patients and their families who together have been waiting for too long.

If you are interested in reading more of my blogs:

Check out the recent blog: Strides in Parkinson's Disease  ~ Dr. Domenico Pratico', MD, FCPP

Dr. Domenico Pratico' , MD, FCPP

Domenico Praticò, MD, holds the Scott Richards North Star Charitable Foundation Chair for Alzheimer’s Research and serves as a Professor and Founding Director of the Alzheimer’s Center at Temple, as well as a Professor of Neural Sciences at Lewis Katz School of Medicine at Temple University.

For more information on the research conducted by Dr. Domenico Pratico, please visit this link.

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