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

NCT01821118

Last updated date
Study Location
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cerebral Amyloid Angiopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients diagnosed with probable CAA using the Boston criteria; with no clinical cognitive impairment

- In general good health

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Cerebral Amyloid AngiopathyStudy Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy NCT01821118
  1. Los Angeles, California
  2. Boston, Massachusetts
  3. Boston, Massachusetts
  4. Boston, Massachusetts
  5. Charlestown, Massachusetts
  6. St. Louis, Missouri
  7. New York, New York
  8. Calgary, Alberta
  9. Toronto, Ontario
  10. Lille Cedex, NAP
  11. Lille Cedex, NAP
  12. Utrecht,
  13. London,
ALL GENDERS
55 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy
Official Title  ICMJE 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
Brief Summary Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called amyloid, predominantly A?40, 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Amyloid Angiopathy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: Ponezumab
  • Placebo Comparator: 2
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2013)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 55 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01821118
Other Study ID Numbers  ICMJE A9951024
2013-001557-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP