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

Cerebral Amyloid Angiopathy Clinical Trial

Official title:

A Phase 2, Randomized, Double Blind Placebo Controlled Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Efficacy Of Pf-04360365 (Ponezumab) In Adult Subjects With Probable Cerebral Amyloid Angiopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821118
• Other study ID #: A9951024
• Secondary ID: 2013-001557-27
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2013
• Last updated: May 6, 2016
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Amyloid Angiopathy

Intervention

Biological:
• Ponezumab
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.

Other:
• placebo
placebo (saline)- given via infusion total infusion time of 20 minutes

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  France,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Day 2 or day 90 in cerebrovascular reactivity.	Change from baseline to Day 2 or day 90 in cerebrovascular reactivity as measured by the slope (amplitude over time to peak) from visual task-evoked fMRI.	screening +90 days	No
Secondary	Change from baseline to Day 2 or Day 90 in cerebrovascular reactivity.	Change from baseline to Day 2 or Day 90 in cerebrovascular reactivity as measured by the time to peak, magnitude, and time to bseline from visual task-evoked fMRI.	screening +90 days	No
Secondary	Change from baseline of total plasma AB species	Change from baseline of total plasma AB species at specified endpoints after the intial dose of study medication on the concentration	screening +240 days	No

External Links

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