Alzheimer’s Treatment, Expanded Access TB006 

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Alzheimers Disease Treatment  - Georgia Wellness Solutions - Griffin GA

Alzheimer’s Treatment Expanded Access TB006 

We know how heavy and overwhelming a dementia diagnosis can feel—for patients and for the people who love and care for them. When available treatment options feel limited, families may wish to gently explore investigational pathways such as access to TB006 through an Expanded Access (compassionate use) program. Our team is here to walk beside you with kindness, clear information, and thoughtful guidance, helping you understand your options and supporting you every step of the way.



What is TB006?



TB006 is an investigational therapy being studied for Alzheimer’s disease and other related dementias. Through the Expanded Access Program (EAP)—sometimes called compassionate use—eligible patients with serious or life-limiting conditions may be considered for access to investigational treatments outside of a clinical trial when standard options are limited or no longer appropriate.

Expanded Access may be considered for patients who have not responded to approved therapies, cannot tolerate available medications due to side effects or contraindications, or do not qualify for—or have access to—active clinical trials. This pathway allows for individualized medical review while maintaining appropriate oversight and safety monitoring.

TB006 is designed to target Galectin-3 (Gal-3), a protein involved in biological processes associated with neuroinflammation and harmful protein aggregation seen in neurodegenerative disease. By selectively blocking Gal-3, TB006 is hypothesized to address multiple disease-related pathways, including chronic inflammation and the formation of toxic brain aggregates, which are thought to contribute to cognitive decline.

Early clinical research has shown that TB006 was generally well tolerated and associated with improvements in cognition and function in some patients with mild dementia. Additional observations from extended treatment periods suggested that certain patients experienced stabilization or improvement in cognitive measures over time. While these findings are encouraging, TB006 remains investigational and is not FDA-approved for general use.

Understanding TB006 and Its Scientific Focus

Alzheimer’s disease is a progressive brain condition that develops gradually over time, affecting memory, thinking, and the ability to perform everyday activities. It is the most common cause of dementia and is associated with the buildup of abnormal proteins in the brain that interfere with normal communication between nerve cells. One of the hallmarks of Alzheimer’s disease is the accumulation of amyloid-beta (Aβ) proteins. These proteins can cluster together to form toxic aggregates and plaques, which disrupt communication between neurons and contribute to cognitive decline.

Research has also identified another important protein involved in this process called Galectin-3 (Gal-3). Gal-3 has been found at elevated levels in the brains of individuals with Alzheimer’s disease and is believed to play a role in promoting inflammation and encouraging amyloid-beta proteins to clump together. By acting as a binding scaffold, Gal-3 may contribute to the formation and persistence of harmful amyloid aggregates that impair synaptic function.

TB006 is an investigational monoclonal antibody designed to specifically target Gal-3. By binding to Gal-3, TB006 is intended to interfere with its ability to support amyloid aggregation and inflammatory signaling. Through this targeted approach, TB006 is being studied for its potential to reduce harmful protein buildup, support healthier neuronal communication, and address multiple disease-related pathways involved in Alzheimer’s disease. While early research has provided encouraging insights, TB006 remains investigational and is not FDA-approved. Ongoing studies and expanded access use continue to help researchers and clinicians better understand its safety, tolerability, and potential clinical impact.

In Other Words.....

Alzheimer’s disease affects how the brain works by clogging up communication between brain cells. Think of brain cells like people trying to talk on the phone — when the lines get jammed, the message can’t get through. One reason this happens is because certain proteins in the brain stick together and form sticky clumps, almost like gum stuck in the wires. These clumps make it harder for brain cells to talk to each other, which can affect memory, thinking, and daily functioning. Researchers have also found a protein called Galectin-3 that acts like a helper or glue, encouraging these harmful clumps to form and increasing irritation in the brain.

TB006 is an investigational medication designed to block that “glue.” By stopping Galectin-3 from doing its job, TB006 is being studied for its potential to reduce the buildup and calm inflammation, with the hope of helping brain cells communicate more normally. TB006 is still being studied and is not FDA-approved, but it may be available to some patients through a special compassionate-use program when other treatment options are limited.

TB006 Expanded Access Program (EAP)

Compassionate access for eligible patients with Alzheimer’s and related dementias. Expanded Access (also called compassionate use) is a pathway that may allow certain patients to receive an investigational medication outside of a clinical trial when other treatment options are limited and clinical trials are not available or appropriate.

Georgia Wellness Solutions supports patients and families by helping navigate this process with clarity, care, and medical oversight.
What Is Expanded Access?

Expanded Access is an FDA-regulated pathway that allows a patient with a serious or life-threatening condition to request access to an investigational drug that is not FDA-approved, when:

Standard treatment options are limited or no longer effective
Clinical trials are not available or the patient does not qualify
A licensed medical provider determines the request is medically appropriate

Expanded Access is not guaranteed and requires clinical review and program approval.

What Is TB006?

TB006 is an investigational therapy currently being studied for Alzheimer’s disease and related dementias. According to TrueBinding’s scientific research, TB006 is designed to target Galectin-3 (Gal-3) — a protein involved in processes associated with neuroinflammation and harmful protein aggregation seen in neurodegenerative disease. TB006 is not FDA-approved and is available only through clinical research pathways or Expanded Access programs.

Who May Be Considered for TB006 Expanded Access?

Patients with certain dementia diagnoses may be considered, including:

Alzheimer’s disease
Frontotemporal dementia
Lewy body dementia
Vascular dementia
Dementia with mixed pathology

Eligibility is determined on an individual basis after review of medical history, prior treatments, current medications, and overall clinical status.
Clinical Research Background

TrueBinding has completed early-phase clinical studies, including Phase 1b/2a trials and open-label extensions, evaluating TB006 in Alzheimer’s disease. During periods between clinical trials, an Expanded Access Program has been established to allow eligible patients continued access under medical supervision. Expanded Access is not a clinical trial and does not replace participation in research studies.

How the TB006 Expanded Access Process Works

Georgia Wellness Solutions helps guide patients and caregivers through the process:

Submit an Inquiry. Patients or caregivers submit a request for information so we can review next steps.
Provider Review. Dr. Vu reviews the patient’s medical history and determines whether pursuing Expanded Access may be appropriate.
Enrollment Coordination. If appropriate, we assist with required documentation and coordination with the Expanded Access program. Please note that we are unable to start administering medication until approved by TrueBindings medical board. This process can take up to
Monitoring & Follow-Up. Patients enrolled in Expanded Access are monitored by their prescribing provider for safety and clinical response.

We understand this can feel overwhelming. Our role is to make the process as clear and supportive as possible.

Costs & Responsibilities

Participation in an Expanded Access program may involve costs related to the manufacture of the investigational medication. These costs are FDA-approved for recovery purposes and are not covered by medical insurance. Patients are responsible for all program-related expenses. We are committed to transparency and will review all anticipated costs with you upfront before scheduling or enrollment, so you can make an informed decision.
Safety & Ongoing Support

TB006 is investigational. All medical questions, side effects, or concerns must be directed to the prescribing provider. Georgia Wellness Solutions remains available to support communication, follow-up, and care coordination throughout the process.
Frequently Asked Questions

Is this a clinical trial?
No. Expanded Access is separate from clinical trials and is used when trials are not available or appropriate.

Is TB006 FDA-approved?
No. TB006 is investigational and accessible only through research or Expanded Access pathways.

Does submitting an inquiry guarantee access?
No. Eligibility and approval depend on clinical review and program criteria.

Who must support my request?
A licensed medical provider must determine the request is appropriate and support the Expanded Access process.

Next Steps……..

If you would like more information or wish to begin the inquiry process, please contact Georgia Wellness Solutions.

Website Disclaimer

This page is for informational purposes only and does not constitute medical advice. TB006 is an investigational medication and is not FDA-approved for general use. Expanded Access eligibility is determined through clinical review and program requirements.

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Participation in the Direct Primary Care program, scheduling appointments, and allowing Dr. John Vu to perform evaluations, treatments, or procedures constitutes acknowledgment that the patient has received appropriate counseling, has had the opportunity to ask questions, and understands the nature, benefits, risks, alternatives, and limitations of the services provided. By proceeding with care, the patient provides informed consent and implied consent for treatment in accordance with Georgia Wellness Solutions’ clinical protocols and standards of care.

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