The slow unraveling of memories, the aching weight of recognition slipping away – it’s a cruel thief, robbing not just those diagnosed with Alzheimer’s but also the loved ones left clinging to fragments of the past. The emotional toll can be overwhelming, the financial strain often staggering, as families navigate the relentless progression of the disease.
But amidst the loss and heartbreak, hope is emerging in the form of a promising new drug called TB006, which researchers believe could change the landscape of Alzheimer’s treatment.
“Nearly 7 million Americans are living with Alzheimer’s disease, a progressive neurodegenerative disorder characterized by memory loss, cognitive decline and behavioral changes,” said Dr. Alita Sikora of Sikora Integrative Medicine. “Two thirds of those are women, and a 45-year-old woman’s estimated lifetime risk of developing Alzheimer’s is 1 in 5.
“Not only are women more likely to have Alzheimer’s, but they are also more likely to be caregivers of those with Alzheimer’s. In 2022, more than 11 million American caregivers provided an estimated 18 billion hours of unpaid care valued at $360 billion. And it’s estimated that by 2050 these costs could reach nearly 1 trillion.”
Statistically, Alzheimer’s kills more than breast cancer and prostate cancer combined, and 1 in 3 seniors dies with Alzheimer’s or another dementia. As dismal as that sounds, a bright spot of hope is emerging, like a light at the end of a long, dark tunnel, in the form of TB006, an experimental drug that targets the underlying mechanisms of Alzheimer’s. The drug is not yet FDA approved, but it is available for compassionate use through Dr. Sikora.
“There are several phases of clinical trials that drug manufacturers have to go through, and it can take up to 10 years to get a drug approved,” Dr. Sikora explained. “But when they find that a drug shows a lot of promise, the FDA will authorize the drug for expanded access, aka compassionate use, giving a patient with no alternative therapy options access to the medication. TB006 is now FDA approved for compassionate use for dementia.
“I am thrilled to be one of the doctors selected to administer this new medication, track the results and report them back to the manufacturer. To qualify, the patient must be over 55, have an estimated score of 24 or less on the MMSE state mental health exam, and have failed with or not been able to tolerate another drug.”
According to True Binding, the company that developed TB006, “the most common forms of dementia are characterized by the abnormal clumping of amyloid beta proteins into toxic plaques, and the abnormal clumping of tau proteins into destructive tangles deposited in the brain, which clog communication between neurons, resulting in memory loss.
“In addition to these plaques and tangles, another protein called GALECTIN-3 (GAL-3) is found at abnormally high levels in the brains of Alzheimer’s patients. GAL-3 binds to A-beta and acts as glue, causing A-beta to bind itself and form toxic plaques. Additionally, GAL-3 binds to defective tau proteins and causes them to clump into toxic tangles. The A-beta plaques and tau tangles then deposit into neurons, blocking communication signals between neurons and leading to memory loss symptoms. The TB006 drug prevents GAL-3 from acting as glue. This reduces and dissolves the toxic A-beta plaques and tau tangles in the brain, which allows neurons to communicate again, resulting in the improvement of cognitive function.”
“The TB006 treatment reduces neuronal impairment in Alzheimer’s disease patients,” Dr. Sikora said. “I’ve actually had calls from people out of the country wanting to get it, but they don’t qualify. You have to come into the office and do an EKG and lab work, and you can’t have any other medical issues. The drug is administered by infusion, and it takes about an hour. We monitor your vital signs during the process. They are recommending infusions once a month, with another EKG and lab test in about three months. We then turn over the data to True Binding.
“They have a portal where for every patient we get we have to submit everything – the physical exam, the blood work, the EKG. We don’t give them the patient’s name or date of birth because the information is going to the FDA. They just get a patient ID number. Soon RB006 will start phase three of clinical trials to be conducted at multiple centers.”
Dr. Sikora was selected as an authorized physician to administer TB006 for compassionate use by the Institutional Review Board and went through extensive training.
Preclinical studies have demonstrated TB006’s efficacy in degrading toxic oligomers and potentially reversing Alzheimer’s disease progression and improving cognitive performance. Clinical evaluations have also proven that TB006 has a favorable safety profile with only a few mild side effects.
Alzheimer’s News Today reported that among 79 participants who completed a three-month regimen, 47 percent showed signs of disease reversal or cognitive improvement, while 28 percent exhibited disease stabilization. These finds suggest that extended TB006 treatment may lead to sustained cognitive benefits.
There’s still a lot to learn about TB006 and further research is necessary to fully understand it’s long-term efficacy and safety, but the current data indicates TB006 has the potential to not only slow but possibly reverse the progression of Alzheimer’s disease.
Dr. Alita Sikora received her medical degree and completed her internship in Internal Medicine at the University of Connecticut School of Medicine. She then completed her residency in Physical Medicine and Rehabilitation at New York Presbyterian Hospital. She’s built her practice around restoring her patient’s quality of life, whether achieved through traditional or integrative medicine. Her office is located at 1255 37th St. Suite B, Vero Beach. Call 772- 228-6883 to schedule an appointment.
