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01
Overview
Phase 2, randomised, double-blind trial of ponezumab in Alzheimer's disease (AD) (6 arms), sponsored by Pfizer. Primary endpoints: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs), Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities and 3 more. Started Dec 2008; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days
PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days
PF-04360365 1 mg/kg
1 mg/kg every 60 days
PF-04360365 3 mg/kg
3 mg/kg every 60 days
PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days
Placebo
Placebo every 60 days
03
Who it enrols
Patients aged 50 or older with probable Alzheimer's disease, MMSE 16-26, and no other significant neurological or cerebrovascular conditions.
04
Endpoints
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365
Mean Plasma Concentration of PF-04360365
Secondary
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score
Disability Assessment for Dementia (DAD) Score
Mean Plasma Concentration of Amyloid Beta (Aβ1-x, Aβ1-40, Aβ1-42)
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta (Aβ1-x, Aβ1-40, Aβ1-42)
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Number of Participants With Serum Anti-Drug Anti Body (ADA)
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