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

NCT ID: NCT01821118

Last Updated: 2017-05-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Amyloid Angiopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Ponezumab

Intervention Type BIOLOGICAL

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.

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BIOLOGICAL

placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UCLA Ronald Reagan Medical Center

Los Angeles, California, United States

Site Status

MGH Stroke Research Center

Boston, Massachusetts, United States

Site Status

Boston Medical Center - Menino Pavilion

Boston, Massachusetts, United States

Site Status

Boston Medical Center - Shapiro Center

Boston, Massachusetts, United States

Site Status

Anthinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, United States

Site Status

Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Columbia University

New York, New York, United States

Site Status

University of Calgary/Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

CHRU de Lille - Hôpital Roger Salengro

Lille, NAP, France

Site Status

CHRU de Lille

Lille, NAP, France

Site Status

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Site Status

University College of London

London, , United Kingdom

Site Status

Countries

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United States Canada France Netherlands United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9951024&StudyName=Study%20Evaluating%20the%20Safety%2CTolerability%20and%20Efficacy%20of%20PF-04360365%20in%20Adults%20with%20Probable%20Cerebral%20Amyloid%20Angiopathy%20

To obtain contact information for a study center near you, click here.

Other Identifiers

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2013-001557-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A9951024

Identifier Type: -

Identifier Source: org_study_id

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