Why Should I Participate in the Cognify Trial?
- The study medication is called TB006, which is a novel monoclonal antibody therapy targeting Galectin-3; a protein implicated in neuroinflammation and cognitive decline in Alzheimer’s disease. TB006 is designed to neutralize this protein’s damaging effects, with the goal of slowing or halting disease progression by reducing brain inflammation and improving neuronal survival.
- You will be treated by a doctor at a
nationally renowned medical center.
- You will be helping to find an effective treatment for Alzheimer’s and dementia for patients like you.
All Participants Receive Treatment
The Cognify Clinical Trial is investigating whether you may see a prolonged reduction in cognitive decline and a possible improvement.
Additional information can be obtained from the national clinical study registry, Clinicaltrials.gov
Click here for more information >>
See if you are Eligible
Patients must be 56 years or Older at the Time of the Clinical Trial.
Documented Clinical Diagnosis
of either:
- Alzheimer's
- Vascular Dementia
- Frontotemporal Dementia
- Lewy Body Dementia
- Dementia with mixed Pathology
Failure or Intolerance to medications such as Donezepil, Rivastigmine, or Similar.
Where is the COGNIFY Trial Taking Place?
6236 Kingspointe Parkway
Suite #6
Orlando, FL 32819
Now Recruiting
Frequently Asked Questions
What is a clinical trial?
A clinical trial is a carefully designed research study in which human volunteers receive specific medical interventions, such as a drug, device, or procedure, under supervision to evaluate their safety and effectiveness.
These trials follow a strict protocol and are conducted in phases to determine how well a treatment works, what side effects it may cause, and how it compares to current standards of care. Participation is voluntary, and all patients are closely monitored throughout the process.
What is the drug or therapy used in the study?
The investigational drug being studied in this trial is TB006, a novel monoclonal antibody therapy targeting Galectin-3; a protein implicated in neuroinflammation and cognitive decline in Alzheimer’s disease.
TB006 is designed to neutralize this protein’s damaging effects, with the goal of slowing or halting disease progression by reducing brain inflammation and improving neuronal survival.
What Is the COGNIFY Clinical Trial?
Provider Overview – TB-006 Compassionate Use in Alzheimer’s Disease.
The COGNIFY Program is a nationwide, FDA-authorized Expanded Access trial for TB-006 — an investigational monoclonal antibody targeting galectin-3, a critical immune molecule at the crossroads of neuroinflammation and protein misfolding in Alzheimer’s disease.
Unlike traditional trials, COGNIFY is structured to allow eligible clinics to provide TB-006 under compassionate use, offering a treatment
Healthcare Professionals
This Why Galectin-3 Matters?
Galectin-3 is an immune lectin (a carbohydrate-binding protein) expressed by microglia, macrophages, and other myeloid cells. While it plays a helpful role in wound healing, galectin-3 becomes pathologic in Alzheimer’s:
● Binds to amyloid and tau, promoting their aggregation
● Activates TLR4 and TREM2 receptors, triggering neuroinflammation
● Amplifies cytokine storms via IL-1β and TNF-α release
● Locks microglia into a chronic inflammatory state
Galectin-3 has been called a “keystone molecule” in neurodegeneration, integrating both the immune and proteinopathy arms of Alzheimer’s progression.
How Soes TB-006 Work?
TB-006 is a humanized monoclonal antibody that neutralizes galectin-3 at two key levels:
1. Blocks its interaction with amyloid and tau, potentially reducing fibril formation
2. Shuts down galectin-3-driven inflammation, calming aggressive microglial behavior
Preclinical and early-phase human data suggest broad cognitive benefits — across mild, moderate, and severe Alzheimer’s — with excellent tolerability.
Note: This is not an FDA-approved treatment but is offered under a strict FDA Expanded Access Program renewed in 2024 for qualifying clinics and patients.
Who May Qualify?
Patients must meet the inclusion criteria under the sponsor protocol:
● Confirmed Alzheimer’s diagnosis ( MMSE 5 to 24)
● Ages 56 years old and older
● No uncontrolled heart, liver, kidney, or active cancer
● Not enrolled in a current TB-006 clinical trial
● Must understand this is an investigational product and; families may bear infusion-related costs
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If you are a provider interested in participating or referring patients, please contact the TB-006 coordination team for protocol details, training, and safety procedures.
