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NCT01821118 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy
A Phase 2 study of Cerebral Amyloid Angiopathy, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 13
- Study locations
NCT01821118: Completed Phase 2 study of Cerebral Amyloid Angiopathy, sponsored by Pfizer.
NCT01821118 is a Phase 2 study of Cerebral Amyloid Angiopathy that has completed, run by Pfizer. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01821118, a Phase 2 study of Cerebral Amyloid Angiopathy, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 13
- Study locations
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.
Primary Outcome
Blood Oxygen Level Dependant (BOLD) fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascu
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01821118 record still lists
NCT01821118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
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.
NCT01821118 lists 13 locations in 9 states (Massachusetts, NAP, California).
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.
What interventions are being tested in trial NCT01821118?
The interventions under investigation include: placebo (OTHER), Ponezumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01821118?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01821118's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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