Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ponezumab · 1 trial · 1 indication
Blood Oxygen Level Dependant (BOLD) fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using Arterial Spin Labeled (ASL) scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and standard errors (SE) are presented in logarithmic (log e) scale.
BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ponezumab | BIOLOGICAL | Infusion of Ponezumab (Day 1=10mg/kg; Day 30 and Day 60 dose = 7.5mg/kg) or placebo (saline); administered via infusion for a total infusion time of 20 minutes. |
| placebo | OTHER | placebo (saline)- given via infusion total infusion time of 20 minutes |
Inclusion Criteria: * Patients diagnosed with probable CAA using the Boston criteria; with no clinical cognitive impairment * In general good health Exclusion Criteria: * Co-morbid diagnosis of clinically documented Alzheimer's disease or significant cognitive impairment * Clinically significant ...
Ponezumab is an investigational monoclonal antibody being studied for the treatment of Cerebral Amyloid Angiopathy, a condition characterized by amyloid deposits in the brain's blood vessels. It is being developed by Pfizer, Inc. for this neurological indication.
Ponezumab is a monoclonal antibody designed to target amyloid beta, a protein that accumulates in the brain and is associated with Cerebral Amyloid Angiopathy. By binding to this protein, the drug aims to reduce its deposition and potentially slow disease progression.
Ponezumab is being developed by Pfizer, Inc., a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Cerebral Amyloid Angiopathy.
Ponezumab is currently in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug, meaning it has not yet been approved by regulatory authorities for commercial use.
Ponezumab has been evaluated in a Phase 2 clinical trial registered as NCT01821118, which studied the safety, tolerability, and efficacy of the drug in adults with probable Cerebral Amyloid Angiopathy. The trial was completed and enrolled 36 participants across the United States, Canada, France, Netherlands, and the United Kingdom.
Yes, Ponezumab is also known as PF-04360365. The clinical trial NCT01821118, which evaluated the drug for Cerebral Amyloid Angiopathy, used the name PF-04360365 in its official title, confirming that both names refer to the same investigational monoclonal antibody.