Frequently Asked Questions

About TB006

What is TB006?

TB006 is an investigational therapy developed by TrueBinding, currently offered through the FDA’s Expanded Access Program (EAP). It has shown promise in reversing dementia symptoms in clinical settings. While outcomes vary, many patients report cognitive improvements. TB006 targets Galectin-3, a protein linked to inflammation and immune dysfunction in the brain. 

Is TB006 a cure for Alzheimer’s or dementia?

No. TB006 is not a cure. It remains an investigational drug, and there is currently no known cure for Alzheimer’s disease or dementia.

How is TB006 different from other Alzheimer’s treatments?

Unlike most FDA-approved Alzheimer’s drugs that focus on reducing beta-amyloid plaques with limited cognitive impact and potential side effects (e.g., brain swelling or microhemorrhages), TB006 takes a unique approach. It targets Galectin-3, aiming to restore immune system function and reduce inflammation in the brain.

How does TB006 work?

TB006 neutralizes Galectin-3 (GAL-3), a protein that contributes to chronic inflammation and immune dysfunction. By blocking GAL-3, TB006 enables the immune system to function properly, potentially leading to neurological healing and symptom improvement.

Treatment & Safety

Is TB006 FDA-approved?

No, TB006 has not yet received full FDA approval. However, it is available under the FDA’s Expanded Access (Compassionate Use) Program for patients with no other treatment options.

What stage is TB006 in clinical development?

TB006 is currently in Phase 2B clinical trials. Full FDA approval is estimated to take several more years.

Is TB006 safe for older adults?

Yes. There is no upper age limit, although patients must be over 55 years old to qualify for treatment.

Have there been any serious side effects?

Among thousands of administrations, only one significant adverse reaction has been reported—in a patient with severe coronary artery disease. Side effects are rare and typically mild (e.g., infusion site irritation, headache, occasional dizziness).

How is TB006 administered?

It is delivered via intravenous (IV) infusion, usually over an hour. No special preparation or post-treatment observation is required aside from proper hydration.

Is TB006 considered safe overall?

Yes. TB006 has demonstrated a strong safety profile under the Expanded Access Program with minimal adverse events reported.

Patient Eligibility & Access

Who qualifies for TB006?

Eligibility is determined by inclusion criteria evaluated by authorized TB006 providers. Patients must be 55+ and have some form of dementia.

Can patients at any stage of dementia receive TB006?

Yes. Patients with mild, moderate, or severe Alzheimer’s or dementia may be eligible, subject to medical assessment.

Can someone with Parkinson’s receive TB006?

Only if the patient also meets criteria for mild dementia. Parkinson’s alone does not qualify.

Can anyone administer TB006?

No. Only authorized TB006 providers can administer the drug. Visit www.tb006providers.com to find one near you.

How can I enroll in the Expanded Access Program?

Contact an authorized TB006 provider listed on the official provider website.

Can I join a clinical trial for TB006?

Yes. Clinical trial participation is available via TrueBinding.

Is TB006 available outside of the Expanded Access Program or clinical trials?

No. TB006 is only available through EAP or ongoing clinical trials.

Is the Expanded Access Program a clinical trial?

No. EAP provides access to investigational treatments for patients who are not eligible for clinical trials and have serious or life-threatening conditions. It is focused on treatment access rather than data collection.

Results & Expectations

How often is treatment needed?

Typically, one infusion every 28 days (+/- 5 days). If progress plateaus, patients may pause treatment until resuming becomes appropriate.

What happens if I miss a dose?

You may simply resume your normal treatment schedule without restarting the protocol.

How long before results appear?

Results vary. Some patients notice improvements after the first treatment, while others require up to 8 sessions. Most see benefits by the third infusion. Disease severity is the main variable.

How will I know if it’s working?

Changes are often most noticeable to caregivers, as patients may not recognize their own improvements. Caregivers are encouraged to log behavioral or cognitive changes.

Is TB006 meant for long-term use?

Yes. Some patients have used TB006 safely for over two years with continued effectiveness and no long-term side effects observed.

Costs & Coverage

Is TB006 covered by insurance?

No. As an investigational drug, TB006 is not reimbursed by insurance.

Is financial assistance available?

Currently, there are limited assistance programs for TB006, but ongoing efforts are being made to secure funding for eligible patients.

What medications interact with TB006?

Most medications are safe to continue. Monoclonal antibodies used for dementia or drugs that suppress the immune system (like some NSAIDs) may be contraindicated. Always consult your provider.

How can I improve my treatment outcomes?
Work closely with your TB006 provider to explore complementary lifestyle adjustments or interventions that could boost therapy benefits.

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