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COMPLETED Phase 2

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

NCT01821118 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER placebo
  • BIOLOGICAL Ponezumab

Study Locations (13)

Massachusetts

  • MGH Stroke Research Center — Boston
  • Boston Medical Center - Menino Pavilion — Boston
  • Boston Medical Center - Shapiro Center — Boston
  • Anthinoula A. Martinos Center for Biomedical Imaging — Charlestown

NAP

  • CHRU de Lille - Hôpital Roger Salengro — Lille
  • CHRU de Lille — Lille

California

  • UCLA Ronald Reagan Medical Center — Los Angeles

Missouri

  • Barnes Jewish Hospital — St Louis

New York

  • Columbia University — New York

Alberta

  • University of Calgary/Foothills Medical Centre — Calgary

Ontario

  • Sunnybrook Health Sciences Centre — Toronto

Utrecht

  • University Medical Center Utrecht — Utrecht

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2013-06
Est. Completion 2015-09
Phase Phase 2

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01821118

The ClinicalTrials.gov registry entry for NCT01821118 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cerebral Amyloid Angiopathy appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01821118 reports 13 study locations spanning 9 distinct geographic areas — top geographies include Massachusetts, NAP, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01821118 about?

NCT01821118 is a clinical study titled "Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy". 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 cor...

What is the current status of trial NCT01821118?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2013-06. Estimated completion is 2015-09.

What conditions does trial NCT01821118 study?

This clinical trial studies the following conditions: Cerebral Amyloid Angiopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01821118?

The interventions under investigation include: placebo (OTHER), Ponezumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01821118?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01821118 being conducted?

This trial has 13 study locations across California, Massachusetts, Missouri, New York, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial