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

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ClinicalTrials.gov Identifier: NCT01821118
Recruitment Status : Completed
First Posted : March 29, 2013
Results First Posted : November 3, 2016
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cerebral Amyloid Angiopathy
Interventions: Biological: Ponezumab
Other: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PF-04360365 Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
Placebo Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.

Participant Flow:   Overall Study
    PF-04360365   Placebo
STARTED   24   12 
COMPLETED   24   11 
NOT COMPLETED   0   1 
Death                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants assigned to study treatment were included in the baseline analysis population.

Reporting Groups
  Description
PF-04360365 Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
Placebo Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
Total Total of all reporting groups

Baseline Measures
   PF-04360365   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   12   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.8  (6.8)   65.0  (5.7)   67.6  (6.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  33.3%      5  41.7%      13  36.1% 
Male      16  66.7%      7  58.3%      23  63.9% 


  Outcome Measures

1.  Primary:   Change From Baseline to Day 2 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked Functional Magnetic Resonance Imaging (fMRI)   [ Time Frame: Baseline, Day 2 ]

2.  Primary:   Change From Baseline to Day 90 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked fMRI   [ Time Frame: Baseline, Day 90 ]

3.  Secondary:   Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Peak From Visual Task-evoked fMRI   [ Time Frame: Baseline, Day 2, Day 90 ]

4.  Secondary:   Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI   [ Time Frame: Baseline, Day 2, Day 90 ]

5.  Secondary:   Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Return to Baseline From Visual Task-evoked fMRI   [ Time Frame: Baseline, Day 2, Day 90 ]

6.  Secondary:   Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)   [ Time Frame: Baseline, 8 hours post dose on Day 1, Day 2, Day 30, 90 and 240 ]

7.  Secondary:   Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities   [ Time Frame: Baseline/Screening, Day 15, Day 45, Day 90, ]

8.  Secondary:   Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time   [ Time Frame: Screening; Days 0, 1, 30, 60, 90, and 240 ]

9.  Secondary:   Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)   [ Time Frame: Baseline up to Day 240 ]

10.  Secondary:   Number of Participants With Laboratory Abnormalities   [ Time Frame: Baseline up to Day 240 ]

11.  Secondary:   Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria   [ Time Frame: Baseline up to Day 240 ]

12.  Secondary:   Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Baseline up to Day 240 ]

13.  Secondary:   Number of Participants With Significant Changes From Baseline in Physical Examination at Final Visit   [ Time Frame: Baseline up to Final Visit (Day 240) ]

14.  Secondary:   Number of Participants With Significant Changes in Neurological Examination Results   [ Time Frame: Baseline up till Day 240 ]

15.  Secondary:   Number of Participants With Anti-PF-04360365 Antibodies   [ Time Frame: Day 1 up to Day 240 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
phone: 18007181021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01821118     History of Changes
Other Study ID Numbers: A9951024
2013-001557-27 ( EudraCT Number )
First Submitted: March 4, 2013
First Posted: March 29, 2013
Results First Submitted: September 14, 2016
Results First Posted: November 3, 2016
Last Update Posted: May 10, 2017