Phase 2
N=36
Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy
Bottom Line
View on ClinicalTrials.gov: NCT01821118 ↗Enrolled (actual)
36
Serious AEs
11.1%
Results posted
Nov 2016
Primary outcome: 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) — 0.954; 0.969; 0.933; 0.999 percent/second
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ponezumab (Biological); placebo (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
0.954; 0.969; 0.933; 0.999 | — |
| 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 |
0.817; 0.958; 0.857; 0.950 | — |
| 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 |
1.012; 1.007; 1.065; 1.015; 1.008; 1.010 | — |
| SECONDARY Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI |
-0.0381; -0.0983; -0.1389; -0.053; -0.0714; -0.0226 | — |
| 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 |
0.0245; -0.022; 0.0558; -0.0179; 0.0045; -0.0174 | — |
| SECONDARY Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB) |
4374.0; 5.3; 13911.8; -37.7; 94468.5; -48.3 | — |
| SECONDARY Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time |
25.4; 25.9; 25.5; 25.9; 25.1; 25.8 | — |
| 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) |
16; 8; 2; 2; 2; 2 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
14; 10 | — |
| SECONDARY Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria |
1; 0; 2; 2; 1; 0 | — |
| SECONDARY Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Significant Changes From Baseline in Physical Examination at Final Visit |
0; 0 | — |
| SECONDARY Number of Participants With Significant Changes in Neurological Examination Results |
2; 1 | — |
| SECONDARY Number of Participants With Anti-PF-04360365 Antibodies |
— | — |
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 Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01821118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.