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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00722046
Registration number
NCT00722046
Ethics application status
Date submitted
23/07/2008
Date registered
25/07/2008
Date last updated
7/11/2022
Titles & IDs
Public title
Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
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Scientific title
A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE DOSES OF PF 04360365 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE.
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Secondary ID [1]
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2008-000986-42
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Secondary ID [2]
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A9951002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - PF-04360365 0.1 mg/kg
Other interventions - PF-04360365 0.5 mg/kg
Other interventions - PF-04360365 1 mg/kg
Treatment: Drugs - Placebo
Other interventions - PF-04360365 3 mg/kg
Other interventions - PF-04360365 8.5 mg/kg
Experimental: PF-04360365 0.1 mg/kg -
Experimental: PF-04360365 0.5 mg/kg -
Experimental: PF-04360365 1 mg/kg -
Placebo Comparator: Placebo -
Experimental: PF-04360365 3 mg/kg -
Experimental: PF-04360365 8.5 mg/kg -
Other interventions: PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
Other interventions: PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)
Other interventions: PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
Treatment: Drugs: Placebo
Placebo every 60 days (10 doses total)
Other interventions: PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
Other interventions: PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
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Assessment method [1]
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An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
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Timepoint [1]
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Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
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Primary outcome [2]
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Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
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Assessment method [2]
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Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
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Timepoint [2]
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Baseline up to Month 24
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Primary outcome [3]
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Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
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Assessment method [3]
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Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion.
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Timepoint [3]
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Baseline up to Month 24
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Primary outcome [4]
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Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
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Assessment method [4]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [4]
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0 Hour on Day 0
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Primary outcome [5]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
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Assessment method [5]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [5]
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0 Hour (pre-dose) on Day 1
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Primary outcome [6]
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Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
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Assessment method [6]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [6]
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0
2 Hours on Day 1
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Primary outcome [7]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
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Assessment method [7]
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0
Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [7]
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0
0 Hour (pre-dose) on Day 60
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Primary outcome [8]
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Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
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Assessment method [8]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [8]
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2 Hours on Day 60
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Primary outcome [9]
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Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
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Assessment method [9]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [9]
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Day 90
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Primary outcome [10]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
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Assessment method [10]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [10]
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0 Hour (pre-dose) on Day 120
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Primary outcome [11]
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Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
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Assessment method [11]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [11]
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2 Hours on Day 120
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Primary outcome [12]
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Mean Plasma Concentration of PF-04360365 on Day 150
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Assessment method [12]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [12]
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Day 150
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Primary outcome [13]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
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Assessment method [13]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [13]
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0 Hour (pre-dose) on Day 180
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Primary outcome [14]
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Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
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Assessment method [14]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [14]
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2 Hours on Day 180
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Primary outcome [15]
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Mean Plasma Concentration of PF-04360365 on Day 210
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Assessment method [15]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [15]
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Day 210
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Primary outcome [16]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
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Assessment method [16]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [16]
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0 Hour (pre-dose) on Day 240
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Primary outcome [17]
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Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
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Assessment method [17]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [17]
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2 Hours on Day 240
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Primary outcome [18]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
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Assessment method [18]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [18]
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0 Hour (pre-dose) on Day 300
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Primary outcome [19]
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Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
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Assessment method [19]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [19]
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2 Hours on Day 300
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Primary outcome [20]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
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Assessment method [20]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [20]
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0 Hour (pre-dose) on Day 360
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Primary outcome [21]
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Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
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Assessment method [21]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [21]
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2 Hours on Day 360
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Primary outcome [22]
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Mean Plasma Concentration of PF-04360365 on Day 390
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Assessment method [22]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [22]
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Day 390
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Primary outcome [23]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
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Assessment method [23]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [23]
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0 Hour (pre-dose) on Day 420
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Primary outcome [24]
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Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
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Assessment method [24]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [24]
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2 Hours on Day 420
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Primary outcome [25]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
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Assessment method [25]
0
0
Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [25]
0
0
0 Hour (pre-dose) on Day 480
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Primary outcome [26]
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Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
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Assessment method [26]
0
0
Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [26]
0
0
2 Hours on Day 480
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Primary outcome [27]
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Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
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Assessment method [27]
0
0
Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [27]
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0 Hour (pre-dose) on Day 540
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Primary outcome [28]
0
0
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
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Assessment method [28]
0
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [28]
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2 Hours on Day 540
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Primary outcome [29]
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Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
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Assessment method [29]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [29]
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Day 570
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Primary outcome [30]
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Mean Plasma Concentration of PF-04360365 on Day 660
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Assessment method [30]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [30]
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Day 660
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Primary outcome [31]
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Mean Plasma Concentration of PF-04360365 on Day 720
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Assessment method [31]
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Only participants received PF-04360365 were analyzed for this outcome measure.
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Timepoint [31]
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Day 720
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Secondary outcome [1]
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Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
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Assessment method [1]
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ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
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Assessment method [2]
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ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
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Timepoint [2]
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Baseline and Month 19
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Secondary outcome [3]
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Disability Assessment for Dementia (DAD) Score at Baseline
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Assessment method [3]
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DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
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Timepoint [3]
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Baseline
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Secondary outcome [4]
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Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
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Assessment method [4]
0
0
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
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Timepoint [4]
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Baseline and Month 19
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Secondary outcome [5]
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Mean Plasma Concentration of Amyloid Beta 1-x (Aß1-x)
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Assessment method [5]
0
0
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Timepoint [5]
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0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
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Secondary outcome [6]
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Mean Plasma Concentration of Amyloid Beta 1-40 (Aß1-40)
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Assessment method [6]
0
0
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Timepoint [6]
0
0
0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
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Secondary outcome [7]
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Mean Plasma Concentration of Amyloid Beta 1-42 (Aß1-42)
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Assessment method [7]
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Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aß1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
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Timepoint [7]
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0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
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Secondary outcome [8]
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Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aß1-x)
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Assessment method [8]
0
0
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Timepoint [8]
0
0
Day 0 (Hour 0), 90, 570
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Secondary outcome [9]
0
0
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aß1-40)
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Assessment method [9]
0
0
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Timepoint [9]
0
0
Day 0 (Hour 0), 90, 570
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Secondary outcome [10]
0
0
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aß1-42)
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Assessment method [10]
0
0
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Timepoint [10]
0
0
Day 0 (Hour 0), 90, 570
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Secondary outcome [11]
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0
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
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Assessment method [11]
0
0
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Timepoint [11]
0
0
Day 0 (Hour 0), 90, 570
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Secondary outcome [12]
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Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
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Assessment method [12]
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Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion
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Timepoint [12]
0
0
Baseline up to Month 24
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Secondary outcome [13]
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Number of Participants With Serum Anti-Drug Anti Body (ADA)
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Assessment method [13]
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Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure.
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Timepoint [13]
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Day 1 up to Month 24
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Eligibility
Key inclusion criteria
- Males or females of non childbearing potential, age > or = 50
- Diagnosis of probable Alzheimer's disease, consistent with criterial from both:
- National Institute of Neurological and Communicable Disease and Stroke and
Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score of 16-26 inclusive
- Rosen-Modified Hachinski Ischemia Score of < or = 4
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Diagnosis or history of other demential or neurodegenerative disorders
- Diagnosis or history of clinically significant cerebrovascular disease
- Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro
hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
- History of autoimmune disorders
- History of allergic or anaphylactic reactions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/12/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/08/2011
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Sample size
Target
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Accrual to date
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Final
198
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
0
0
Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
0
0
The Queen Elizabeth Hospital and Health Service - Woodville South
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Recruitment hospital [3]
0
0
Heidelberg Repatriation Hospital, Austin Health - Heidelberg West
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Recruitment hospital [4]
0
0
The McCusker Foundation for Alzheimer's Disease Research - Nedlands
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Recruitment postcode(s) [1]
0
0
5000 - Adelaide
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Recruitment postcode(s) [2]
0
0
5011 - Woodville South
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Recruitment postcode(s) [3]
0
0
3084 - Heidelberg West
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Recruitment postcode(s) [4]
0
0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Illinois
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Kansas
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New Jersey
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Rhode Island
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Antwerpen
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Country [8]
0
0
Belgium
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State/province [8]
0
0
Edegem
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Country [9]
0
0
Belgium
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State/province [9]
0
0
Jette
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Country [10]
0
0
Belgium
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State/province [10]
0
0
Leuven
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Country [11]
0
0
Canada
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State/province [11]
0
0
British Columbia
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Country [12]
0
0
Canada
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State/province [12]
0
0
Ontario
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Country [13]
0
0
Canada
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State/province [13]
0
0
Quebec
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Country [14]
0
0
Korea, Republic of
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State/province [14]
0
0
Gyeonggi
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Country [15]
0
0
Korea, Republic of
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State/province [15]
0
0
Seoul
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Country [16]
0
0
United Kingdom
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State/province [16]
0
0
Chesire
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Country [17]
0
0
United Kingdom
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State/province [17]
0
0
Wiltshire
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Country [18]
0
0
United Kingdom
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State/province [18]
0
0
Manchester
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Country [19]
0
0
United Kingdom
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State/province [19]
0
0
Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Purpose of the study is to determine whether multiple dose administration of PF-04360365 is
safe and well tolerated in patient with mild to moderate Alzheimer's disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00722046
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00722046
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