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). Some patients have reported improvements in dementia symptoms under the Expanded Access Program, though results vary and are not guaranteed. TB006 targets Galectin-3, a protein linked to inflammation and immune dysfunction in the brain.

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

TB006 neutralizes Galectin-3 (GAL-3), a protein that contributes to chronic inflammation and immune dysfunction. By targeting GAL-3, TB006 aims to support immune system function. Some patients have reported symptom improvements, though the mechanism and outcomes are still under clinical investigation.

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

TB006 has been administered to patients over 55 with no upper age limit under the EAP. As with any investigational treatment, patients should consult with their provider to assess individual suitability.

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

TB006 has shown a favorable safety profile in EAP data to date, with minimal adverse events reported. However, as an investigational drug, long-term safety data is still being collected. Always consult your provider.

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.
Yes. Patients with mild, moderate, or severe Alzheimer’s or dementia may be eligible, subject to medical assessment.
Only if the patient also meets criteria for mild dementia. Parkinson’s alone does not qualify.

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

Contact an authorized TB006 provider listed on the official provider website.
Yes. Clinical trial participation is available via TrueBinding.
No. TB006 is only available through EAP or ongoing clinical trials.
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.
You may simply resume your normal treatment schedule without restarting the protocol.

Results vary significantly by patient. Some have reported improvements after the first treatment; others have required several sessions. Disease severity and individual health factors are the primary variables. Disease severity is the main variable.

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

Yes. Some patients have used TB006 for over two years. Long-term safety data is still being gathered through ongoing clinical trials. Consult your provider regarding long-term treatment planning.

Costs & Coverage

Is TB006 covered by insurance?

No. As an investigational drug, TB006 is not reimbursed by insurance.
Currently, there are limited assistance programs for TB006, but ongoing efforts are being made to secure funding for eligible patients.
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.
Work closely with your TB006 provider to explore complementary lifestyle adjustments or interventions that could boost therapy benefits.