CAA: A phase 2 study to evaluate the safety, tolerability, pharmacokinetics and efficacy of Ponezumab in adult subjects with probable Cerebral Amyloid Angiopathy
Sponsor: Pfizer
Investigators: Carlos Kase MD (principal), Viken Babikian MD, Thanh Nguyen MD, Jose Romero MD, Hesham Masoud MD, Hugo Aparicio MD
Summary
Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more hemorrhages in the brain cortex in individuals 55 years of age or older. This study will examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30 and 60. Subjects will be followed for 6 months after receiving the last dose of study medication.