FDA-Authorized Expanded Access Pathway for Eligible Patients
A Guided Pathway to Understand TB006 Access
TB006 Treatment Centers of America helps families understand whether an eligible patient may be considered for TB006, an investigational IV monoclonal antibody being evaluated for Alzheimer’s disease and related dementias through a structured Expanded Access process.
Private-pay pathway. Eligibility, testing, costs, and next steps are reviewed on the call. Access is not guaranteed.
TB006 is investigational and is not an FDA-approved commercial treatment. The access call is informational and does not determine final eligibility or approval.
Access Pathway
- 1
Access Call
Free 20-min intro
- 2
Eligibility Review
Records & criteria
- 3
Program Review
Pathway & next steps
What TB006 Is
An Investigational IV Monoclonal Antibody Being Evaluated for Alzheimer’s Disease and Related Dementias
TB006 is an investigational IV monoclonal antibody being evaluated for Alzheimer’s disease and related dementias. It is not an FDA-approved commercial treatment.
TB006 is associated with research involving Galectin-3, a protein described in the source materials as involved in inflammatory and immune-response pathways. For eligible patients, access may be considered through a structured Expanded Access process involving physician review, program review, testing, and clinical oversight.
TB006 remains investigational. Participation or access does not guarantee treatment approval or clinical benefit.
Why Families Are Asking
When Standard Options Feel Limited, Families Often Look for Clearer Next Steps
Families exploring Alzheimer’s disease and related dementias are often trying to understand what options may exist beyond the standard path. TB006 has drawn attention because it is being evaluated as an investigational therapy through a controlled access process.
But interest is not the same as eligibility. The right next step is not to assume access or expected benefit. The right next step is to understand whether the patient may be appropriate for review through the Expanded Access pathway.
- Families may be looking for clarity when the current path feels limited.
- TB006 access requires structured review.
- Eligibility, testing, costs, and next steps are reviewed before moving forward.
- Access is not guaranteed.
Understanding Expanded Access
Expanded Access Is a Controlled Pathway, Not Open Treatment Access
Expanded Access may allow eligible patients with serious conditions to access an investigational drug outside of a traditional clinical trial when specific requirements are met. For TB006, this process involves review through a structured program pathway, including physician review, program review, testing requirements, and clinical oversight.
This pathway does not mean every patient will qualify. It also does not mean TB006 is FDA-approved as a commercial treatment. The first step is a conversation to understand whether the patient may be appropriate for further evaluation.
Eligibility-Based
Patients must be reviewed against program requirements before moving forward.
Clinically Reviewed
The process may involve medical records, labs, cognitive information, imaging, genetic testing, and physician review.
Access Not Guaranteed
The initial call is informational and does not determine final eligibility, approval, or treatment access.
Private-pay pathway. Eligibility, testing, costs, and next steps are reviewed on the call. Access is not guaranteed.
Who May Be Considered
Candidacy Depends on Medical History, Testing, and Program Review
A patient may be considered for TB006 review based on multiple factors, including dementia or memory-loss history, symptom profile, cognitive information, lab work, genetic testing, imaging, EKG, medical records, and program review.
Families do not need to determine candidacy on their own. The first call is designed to explain the pathway, identify obvious fit or misfit, and determine whether the patient should move into the next evaluation step.
Possible Review Factors
- Alzheimer's disease or related dementia history
- Current cognitive profile or MMSE information
- Medical history and records
- Labs and safety-related screening
- EndoDNA / GAL-3 Function and Activity DNA Test
- MRI and EKG review, when required
- Physician and program review
- Caregiver/family authority or consent when applicable
These items are not final inclusion or exclusion criteria. They are possible review factors that may be part of the Expanded Access review process.
The Access Pathway
A Structured Process Designed to Help Families Understand Next Steps
TB006 access is not an open enrollment process or standard commercial treatment pathway. Families move through a structured review process designed to determine whether a patient may be appropriate for further evaluation and program consideration.
- 1
Schedule a Free 20-Minute TB006 Access Call
Speak with a care coordinator or program representative to discuss the patient's situation, explain the pathway, and review whether moving forward may be appropriate.
- 2
Initial Fit Discussion
Review high-level medical history, caregiver questions, logistics, and whether the patient appears appropriate for deeper evaluation.
- 3
Evaluation and Testing Process
If appropriate, the next phase may involve medical records, lab work, cognitive information, imaging review, EKG, and EndoDNA / GAL-3 Function and Activity DNA testing.
- 4
Physician and Program Review
Records and testing may be reviewed through physician oversight and program review processes associated with the Expanded Access pathway.
- 5
Monthly Treatment Visits if Approved
Approved patients may receive monthly monitored treatment visits at the Palm Beach Gardens clinic.
Access is not guaranteed. The initial call and evaluation process do not determine final treatment approval.
Private-pay pathway. Eligibility, testing, costs, and next steps are reviewed on the call. Access is not guaranteed.
Local and Traveling Patients
Patients May Inquire from Outside the Area, but Monthly Visits Are Required if Approved
TB006 Treatment Centers of America is currently operating through the Palm Beach Gardens clinic under physician oversight and program review processes associated with the Expanded Access pathway.
Families may begin the process from outside Florida or outside the local area. However, approved patients should expect to travel to Palm Beach Gardens for ongoing monthly treatment visits, monitoring, and clinical follow-up.
- Initial call can begin remotely
- Caregivers may participate in discussions
- Travel planning may become part of the process if approved
- Monthly monitoring is part of the structured pathway
Palm Beach Gardens, FL
Clinic for monthly monitored visits
What Happens After the Call
The Initial Call Is Designed to Provide Clarity Before Any Evaluation Begins
The 20-minute TB006 Access Call is designed to help families understand the pathway before moving into deeper evaluation steps.
During the call, the team may:
- answer questions about the Expanded Access pathway
- explain potential testing and records requirements
- discuss local versus traveling-patient logistics
- identify obvious fit or misfit situations
- explain next steps if further evaluation appears appropriate
The initial call is informational only. It does not determine final eligibility, treatment approval, or treatment access.
Understanding the pathway
Walk through how the Expanded Access process works and where this call fits within it.
Reviewing possible next steps
Identify what a thoughtful next step may look like for your specific situation.
Discussing testing and records
Talk through the kinds of records, labs, imaging, and testing that may be requested.
Determining whether deeper evaluation makes sense
Decide together whether moving into a more detailed evaluation is appropriate.
Private-pay pathway. Eligibility, testing, costs, and next steps are reviewed on the call. Access is not guaranteed.
Important Information
This is a private-pay investigational Expanded Access pathway. TB006 is not an FDA-approved commercial treatment. Costs, eligibility, testing, and next steps are reviewed during the initial Zoom call. Access is not guaranteed.
Important Distinctions
Understanding What This Pathway Is — and What It Is Not
This Is
- An investigational Expanded Access pathway
- Eligibility-based
- Physician-reviewed
- Program-reviewed
- Private-pay
- Structured around testing, records, and clinical oversight
This Is Not
- An FDA-approved commercial treatment
- Guaranteed access
- Guaranteed improvement
- A free treatment program
- A cure
- Emergency treatment
- A replacement for medical advice from the patient’s current physician
TB006 is investigational. Access, approval, and clinical benefit are not guaranteed.
Family Experience
Support and Clarity Through the Access Process
Families considering an investigational access pathway often want to understand the process before making any decisions. These comments speak only to the experience of communication, support, and guidance — not treatment outcomes.
“The team was very supportive — from the front desk to the nurses.”
— Caregiver spouse
“We appreciated understanding what the next steps would involve.”
— Family caregiver
“I can only share our experience. I would encourage families to get the information they need and decide what feels right for their situation.”
— Patient spouse
Comments reflect process and communication experience only and do not represent treatment outcomes. TB006 is investigational and access is not guaranteed.
Common Questions
Questions Families Often Ask Before Taking the Next Step
Start With a Free 20-Minute TB006 Access Call
The first step is a conversation. The call helps families understand the Expanded Access pathway, possible eligibility considerations, testing requirements, private-pay costs, and next steps.
Private-pay pathway. Eligibility, testing, costs, and next steps are reviewed on the call. Access is not guaranteed.