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

Last updated: April 3, 2017
Sponsor: Pfizer
Overall Status: Completed

Phase

2

Condition

Amyloidosis

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT01821118
A9951024
2013-001557-27
  • Ages 55-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with probable CAA using the Boston criteria; with no clinicalcognitive impairment

  • In general good health

Exclusion

Exclusion Criteria:

  • Co-morbid diagnosis of clinically documented Alzheimer's disease or significantcognitive impairment

  • Clinically significant syncope, epilepsy, head trauma or clinically significantunexplained loss of consciousness within the last 5 years

  • Subject's body weight exceeding 100kg

  • Women of childbearing potential.

Study Design

Total Participants: 36
Study Start date:
June 01, 2013
Estimated Completion Date:
September 30, 2015

Connect with a study center

  • University of Calgary/Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • CHRU de Lille

    Lille Cedex, NAP 59037
    France

    Site Not Available

  • CHRU de Lille - Hôpital Roger Salengro

    Lille Cedex, NAP 59037
    France

    Site Not Available

  • University Medical Center Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • University College of London

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • UCLA Ronald Reagan Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Boston Medical Center - Menino Pavilion

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Boston Medical Center - Shapiro Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • MGH Stroke Research Center

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Anthinoula A. Martinos Center for Biomedical Imaging

    Charlestown, Massachusetts 02129
    United States

    Site Not Available

  • Barnes Jewish Hospital

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Colombia University

    New Yorl, New York 10032
    United States

    Site Not Available

  • eRT

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • University of Texas at Houston Medical School

    Houston, Texas 77030
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.