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Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01821118•Pfizer

View on ClinicalTrials.gov

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

Age

55 - 90 years

Sex

ALL

Healthy Volunteers

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.

Locations (13)

UCLA Ronald Reagan Medical Center

Los Angeles, California, United States

MGH Stroke Research Center

Boston, Massachusetts, United States

Boston Medical Center - Menino Pavilion

Boston, Massachusetts, United States

Boston Medical Center - Shapiro Center

Boston, Massachusetts, United States

Anthinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

Columbia University

New York, New York, United States

University of Calgary/Foothills Medical Centre

Calgary, Alberta, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

CHRU de Lille - Hôpital Roger Salengro

Lille, NAP, France

Key Dates

Start Date

June 1, 2013

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

May 10, 2017

Enrollment

ACTUAL participants

Conditions

Cerebral Amyloid Angiopathy

Interventions

Ponezumab

BIOLOGICAL

placebo

OTHER

A Study of AMDX-2011P in Participants With CAA

NCT05709314

Cerebral Amyloid Angiopathy

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COMPLETED

Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy

NCT05394636

Cerebral Amyloid AngiopathySiderosis

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UNKNOWN

Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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