Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Cerebral Amyloid Angiopathy

In brief

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.

Key facts

Study ID

NCT01821118

Run by

Pfizer

People needed

36

Starts

2013-06-01

Expected to finish

2015-09-01

Last updated by the study team

2017-05-10

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with probable CAA using the Boston criteria; with no clinical cognitive impairment
• In general good health

You may not qualify if…

• Co-morbid diagnosis of clinically documented Alzheimer's disease or significant cognitive impairment
• Clinically significant syncope, epilepsy, head trauma or clinically significant unexplained loss of consciousness within the last 5 years
• Subject's body weight exceeding 100kg
• Women of childbearing potential.

Where it is running

• UCLA Ronald Reagan Medical Center — Los Angeles, California, United States
• MGH Stroke Research Center — Boston, Massachusetts, United States
• Boston Medical Center - Menino Pavilion — Boston, Massachusetts, United States
• Boston Medical Center - Shapiro Center — Boston, Massachusetts, United States
• Anthinoula A. Martinos Center for Biomedical Imaging — Charlestown, Massachusetts, United States
• Barnes Jewish Hospital — St Louis, Missouri, United States
• Columbia University — New York, New York, United States
• University of Calgary/Foothills Medical Centre — Calgary, Alberta, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• CHRU de Lille - Hôpital Roger Salengro — Lille, NAP, France
• CHRU de Lille — Lille, NAP, France
• University Medical Center Utrecht — Utrecht, Utrecht, Netherlands
• University College of London — London, United Kingdom

Full record on ClinicalTrials.gov

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