TB006 for Dementia Now Available Through Expanded Access

A New Avenue of Hope for Dementia Patients

Dementia, including Alzheimer’s disease, continues to affect millions of individuals and families, often progressing despite currently approved treatments. While breakthroughs in research have been limited, a new investigational drug—TB006—offers renewed hope. This treatment, developed by TrueBinding, has shown early signs of reversing cognitive symptoms in clinical trials. Though still under investigation, TB006 is now accessible to some patients through early access programs. At Sikora Medical in Vero Beach, FL, we are proud to participate in making this potential therapy available to qualifying individuals.

What Is TB006?

TB006 is an investigational drug developed by TrueBinding. In their Phase 2a clinical trial, patients who received TB006 for one month demonstrated signs of symptom reversal and improvements in memory and cognition. While TrueBinding is planning a Phase 2b trial in 2025, the drug is available to patients through compassionate use or early access. We are pleased to offer this innovative treatment to patients at Sikora Medical in Vero Beach, FL through the Expanded Access Program.

Please be aware that, as TB006 is still in the investigational stage, the benefits of the drug cannot be guaranteed for everyone. However, if you or your loved ones are suffering from dementia and have exhausted other treatment options, TB006 may offer promising new hope. To learn more, please schedule a consultation with Dr. Sikora.

How Does TB006 Work?

TB006 works by binding to and lowering amounts of Galectin-3, a different mechanism than any of the currently approved Alzheimer’s medications. Galectin-3 binds to amyloid beta and acts like glue, causing amyloid beta proteins to stick to one another and form larger plaques. These plaques then deposit in the tissue between neurons, blocking signals and leading to cognitive impairment.

In addition, Galectin-3 is proinflammatory and activates the brain’s immune system (microglial cells), leading to neural inflammation and nerve cell damage or destruction. Galectin-3 is generally very high in the brains of patients with Alzheimer’s disease.

TB006 prevents Galectin-3 from attaching to amyloid beta (blocking amyloid plaque formation) and prevents it from causing microglial activation. In doing so, TB006 may potentially decrease the amount of beta amyloid plaques and lower inflammation, allowing nerve cells to heal and function more optimally.

How Do I Get Access to TB006?

TB006 is currently undergoing clinical trials and is not yet FDA approved. There are two ways to obtain TB006:

1. Participation in a Clinical Trial

Not everyone meets the eligibility criteria, and there is a possibility of being enrolled into the placebo group.

2. Expanded Access Program (EAP)

The FDA allows eligible patients to access investigational treatments when there is no satisfactory alternative treatment available. TB006 has been approved for compassionate use (EAP) for dementia since June 2023.

How Much Does TB006 Cost?

Clinical Trial Access: If you enroll in and are accepted into a clinical trial, the medication is free. However, there is a chance of being randomized into the placebo group.

Expanded Access Program: If you choose to obtain TB006 through the Expanded Access Program, please note that the medication is expensive. The cost includes:

• Manufacturing of the drug
• Physician and clinic fees for administering and monitoring the treatment
• Required exams, imaging, and lab work as part of the EAP protocol

Eligibility Criteria

Since TB006 is still under investigation, we can only administer the medication to those who meet specific eligibility requirements:

• You must be diagnosed with Alzheimer’s disease (or another form of dementia)
• You must be at least 55 years of age
• You must have cognitive disability due to your current condition
• You must have failed at least one other dementia medication
• You must be unable or ineligible to enroll in another clinical trial

If you feel you meet the above criteria and are interested in learning more about TB006, please reach out to us to discuss details regarding fees, testing, and the structure of the Expanded Access Program.

Ready to Learn More?

If you or a loved one is living with Alzheimer’s disease or another form of dementia and have not found success with conventional treatments, TB006 may represent a promising option. At Sikora Medical, our team is committed to helping patients explore every viable path to better cognitive health.

Founded by Dr. Alita Sikora, Sikora Medical in Vero Beach, FL offers an integrative and personalized approach to treatment, backed by extensive experience in Physical Medicine and Rehabilitation.