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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01821118
First received: March 4, 2013
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Cerebral Amyloid Angiopathy
Biological: Ponezumab
Other: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline to Day 2 or day 90 in cerebrovascular reactivity. [ Time Frame: screening +90 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from baseline to Day 2 or Day 90 in cerebrovascular reactivity. [ Time Frame: screening +90 days ] [ Designated as safety issue: No ]
    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.

  • Change from baseline of total plasma AB species [ Time Frame: screening +240 days ] [ Designated as safety issue: No ]
    Change from baseline of total plasma AB species at specified endpoints after the intial dose of study medication on the concentration


Estimated Enrollment: 36
Study Start Date: June 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Placebo Comparator: 2 Other: placebo
placebo (saline)- given via infusion total infusion time of 20 minutes

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821118

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, California
UCLA Clinical & Translational Research Center Recruiting
Los Angeles, California, United States, 90095
UCLA Ronald Reagan Medical Center Recruiting
Los Angeles, California, United States, 90095
United States, Massachusetts
Boston Medical Center - Shapiro Center Recruiting
Boston, Massachusetts, United States, 02118
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
MGH Stroke Research Center Recruiting
Boston, Massachusetts, United States, 02114
Boston Medical Center - Menino Pavilion Recruiting
Boston, Massachusetts, United States, 02118
Athinoula A. Martinos Center for Biomedical Imaging Recruiting
Charlestown, Massachusetts, United States, 02129
United States, Missouri
Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
United States, Texas
University of Texas at Houston Medical School Recruiting
Houston, Texas, United States, 77030
Canada, Alberta
University of Calgary/Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
France
Hôpital cardiologique Recruiting
Lille Cedex, France, 59037
CHRU de Lille - Hôpital Roger Salengro Recruiting
Lille Cedex, France, 59037
Netherlands
University Medical Center Utrecht Not yet recruiting
Utrecht, Netherlands
United Kingdom
UCL Institute of Neurology National Hospital for Neurology and Neurosurgery Recruiting
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01821118     History of Changes
Other Study ID Numbers: A9951024, 2013-001557-27
Study First Received: March 4, 2013
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Cerebral amyloid angiopathy (CAA)
cerebrovascular reactivity
functional MRI
randomized
double blind
safety
efficacy

Additional relevant MeSH terms:
Cerebral Amyloid Angiopathy
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014