K2 Medical Research Offers Hope for Families Impacted by Alzheimer’s Disease
If you have a family history of Alzheimer’s Disease, you may worry whether you, too, will face cognitive impairment. You may wonder how (or if) you can prevent symptoms.
Good news. If you’re over 50, and you live in the Greater Orlando area, you now have access to answers that could potentially change the course of your life for the better.
At K2 Medical Research, a free blood test reveals whether you have the biomarkers —known as amyloid and tau proteins — that are associated with Alzheimer’s Disease.
“What we do know is these proteins — amyloid and tau proteins — start forming in patients in their late 40s through 60s, primarily, and what they do is these proteins then create protein plaques on the brain that ultimately cause the brain cells to get sick. That period can be 10 to 20 years before a patient has their first symptom,” says Dr. Brandon Lenox, who is the co-founder and chief medical officer at K2.
The process looks something like this: Normal amyloids become abnormal beta amyloids, and these proteins start sticking to brain cells, creating a neurotoxic landscape. After many years of this, the cells become sick, and they produce tau. Under normal conditions, tau lives in brain cell membranes, transporting lipids. But when the brain cell is sick, the tau, too, becomes dysfunctional, and the abnormal tau is excreted from the cell. The tau binds to the plaque, making everything even more inflamed.
Eventually, things become so toxic, you start to see cell death. And once these cells are gone, there is no way to regenerate them.
“When these cells die, due to this pathologic process, you start to get symptoms,” says Lenox. “Because the brain cells cannot effectively communicate with each other. The goal is that you identify the disease early, you treat the protein plaques early, and that they don’t progress to signs and symptoms. So we’re actually trying to prevent the onset of signs and symptoms of the disease.”
If your blood-based biomarker reveals the presence of these proteins, you can opt-in to a prevention study, taking a monoclonal antibody drug like Donanemab or Lecanemab — the latter of the two was recently stamped with conditional approval by the FDA — and potentially avoid the onset of symptoms altogether.
“Monoclonal antibody technology is stimulating and triggering our immune system to fight the disease,” says Lenox. “So specifically related to Alzheimer’s Disease, we’ve taken these monoclonal antibodies and used them to target the amyloid and tau proteins, and what ultimately happens is that triggers our own immune system to reduce and attack these plaques that are forming on the brain that ultimately are part of the pathology of the disease.”
An antibody would attach to the amyloid, and this would lead to the creation of a macrophage, which then destroys the antibody and the amyloid.
“These drugs have been shown to be effective in reducing the amyloid and tau burden on the brain,” Lenox says.
The ultimate goal is to make these biomarker tests available on a broader scale.
“Our hope is that, over the next year, we will see these blood-based biomarkers be approved by the FDA for use in the general healthcare setting,” says Lenox. “I mean the goal is that these biomarkers become part of your annual physical, and we’re truly screening for risk factors for Alzheimer’s disease.”
The biomarker blood test is also part of K2’s diagnostic process when symptoms are present.
People who present with memory loss symptoms can be enrolled in a study that begins with a comprehensive brain health assessment.
“It’s about a $30,000 workup for free,” says Lenox. “We’ll do a battery of cognitive tests to determine if the cognitive screens support their concerns with their symptomatology.”
This includes extensive blood work, a physical exam, a cardiovascular workup, and the blood-based biomarker test.
If that biomarker is negative, that simply means the pathology for Alzheimer’s Disease isn’t present. Another form of dementia could be at play, and at that point, the K2 team would refer the patient to another neurologist for a workup.
As you likely know, Alzheimer’s Disease is the most common form of dementia, but it is not the only form. Other forms, like Lewy Body or Frontotemporal Dementia, account for about 30 to 35 percent of dementias.
What makes Alzheimer’s Disease unique, as far as pathology goes, are the amyloid and tau biomarkers.
The patient’s cognitive decline could also be considered “normal” or age-related, and therefore unrelated to dementia.
But if the biomarkers are positive, a safety MRI is conducted to ensure the brain would be receptive to treatment.
At this point, the team would then do a PET scan of the brain to actually see the proteins visually. This is a big deal for a couple of reasons. For one thing, the procedure is typically cost-prohibitive at $15,000 a pop, but patients at K2 don’t pay a dime for the definitive diagnosis. The PET scan is the only way to actually visualize the proteins, but insurance companies don’t cover the procedure when it comes to this purpose.
This is why, in the past, it’s been hard to get an actual diagnosis of Alzheimer’s Disease.
“If you presented, as a patient to your family physician or a neurologist, with changes in cognition or memory loss, they would do a clinical exam, take some cognitive assessments, and maybe do an MRI, and try to piece that picture together, and make an educated guess on: Is it Alzheimer’s Disease?” says Lenox. “But the only way to definitively diagnose it is through a PET scan, up until now, which nobody has access to.
The goal has been to develop a more efficient and cost-effective screening tool. The initial screen tool should always be relatively inexpensive, be able to be replicated on the masses, and be relatively accurate at predicting disease. So there’s been a big race up until over the last couple of years to develop a blood test for these proteins that correlates to PET scan, so that we can take a blood test and it highly correlates to a positive PET scan.”
This is part of what sets K2 apart from your typical neurologist when it comes to Alzheimer’s Disease.
“We have the ability to actually diagnose through PET scans, and blood tests, which, when you go to a neurologist, they don’t have access to those right now. And the general healthcare community, they don’t have the blood tests, and they can’t order the PET scans because insurance won’t cover that.”
But at K2, a patient who tests positive for the proteins and who also has a positive PET scan can then choose to proceed for treatment, or the second phase of the study.
“The goal with treatment is that we prevent, or we stop or slow the progression of this pathology, and the goal is that we’re trying to prevent additional cell death,” says Lenox.
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