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Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00397891
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : September 4, 2014
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Alzheimer Disease
Intervention Drug: bapineuzumab
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1. Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1. Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1. Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1. Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Period Title: Overall Study
Started 6 6 6 6 8
Completed 5 6 6 6 7
Not Completed 1 0 0 0 1
Reason Not Completed
Withdrawal by Subject             1             0             0             0             1
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo Total
Hide Arm/Group Description Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1. Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1. Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1. Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1. Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 8 32
Hide Baseline Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
60.67  (5.16) 72.17  (8.38) 72.17  (10.87) 64.83  (5.19) 68.75  (8.89) 67.78  (8.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
Female
3
  50.0%
1
  16.7%
3
  50.0%
3
  50.0%
4
  50.0%
14
  43.8%
Male
3
  50.0%
5
  83.3%
3
  50.0%
3
  50.0%
4
  50.0%
18
  56.3%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description 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 the 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 are events between dose of study medication and up to 52 weeks after the dose that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 8
Measure Type: Number
Unit of Measure: participants
AEs 5 3 6 3 7
SAEs 0 0 0 0 0
2.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Physical Examinations
Hide Description Physical examination included the assessment of abdomen, back/spinal, breasts, external genitalia, extremities, general appearance, head, eyes, ears, nose, throat (HEENT), heart, lungs, lymph nodes and skin.
Time Frame Screening up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 8
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
3.Primary Outcome
Title Number of Participants With Vital Signs of Potential Clinical Importance
Hide Description Criteria for determining potentially clinically important (PCI) vital signs was described as: supine blood pressure (BP)- systolic (greater than or equal to [>=]160 millimeter mercury [mm Hg] or less than or equal to [<=]90 mm Hg and increase or decrease of >=20 mm Hg compared to baseline value), supine diastolic BP (>=100 mm Hg or <= 50 mm Hg and increase or decrease of >=15 mm Hg compared to baseline value), supine pulse rate (>=120 beats per minute (bpm) or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), body temperature (>38.3 degree Celsius and <35 degree Celsius).
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 8
Measure Type: Number
Unit of Measure: participants
2 0 2 1 1
4.Primary Outcome
Title Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance
Hide Description Criteria for determining PCI ECG result was described as: heart rate (>=120 bpm or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), PR interval (>=220 millisecond (msec) and change of >=20 msec compared to baseline value), QRS interval (>=120 msec), corrected QT (QTc) interval for men (>450 msec), QTc interval for women (>470 msec).
Time Frame Screening up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 8
Measure Type: Number
Unit of Measure: participants
0 0 0 0 1
5.Primary Outcome
Title Number of Participants With Laboratory Test Results of Potential Clinical Importance
Hide Description Criteria for PCI laboratory results: hematology (hematocrit [decrease >=5%], hemoglobin [decrease >=20gram/liter {g/L}] from baseline, white blood cells [<3], neutrophils [<1.5], platelet [<100], eosinophils [>0.5] *10^9/L); blood chemistry (sodium [>5], potassium [>0.5], fasting glucose [>0.83], phosphorous [>0.162] millimole/L [mmol/L] above upper limit of normal [ULN] and below lower limit of normal [LLN], non-fasting glucose >5 mmol/L above ULN, >0.56 mmol/L below LLN, creatinine >1.36*ULN, blood urea nitrogen >1.5*ULN, calcium [change of >=0.25 mmol/L], total protein [change of >=20g/L], albumin [change of >=10g/L], uric acid [change of >0.119mmol/L] from baseline and outside normal limits); Liver function tests (alanine aminotransferase/serum glutamic pyruvic transaminase [ALT/SGPT] and aspartate aminotransferase/serum glutamic oxaloacetic transaminase [AST/SGOT] >2*ULN, total bilirubin >2*ULN, alkaline phosphatase >1.5*ULN, gamma-glutamyl-transpeptidase [GGT] >3*ULN).
Time Frame Week 1 up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 8
Measure Type: Number
Unit of Measure: participants
6 4 3 5 5
6.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Neurological Examinations
Hide Description Neurological examination included the assessment of mental status, cranial nerves, visual fields, sensory, motor, gait, primitive reflexes and tendon reflexes.
Time Frame Screening up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 8
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
7.Primary Outcome
Title Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6
Hide Description MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.8  (2.9) 21.0  (3.6) 21.0  (4.6) 20.2  (2.8) 20.6  (3.0)
Change at Week 6 -0.2  (2.1) 0.0  (2.3) -0.3  (3.0) -0.2  (3.8) -1.9  (3.1)
8.Primary Outcome
Title Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16
Hide Description MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (2.9) -0.7  (4.1) 0.7  (2.4) -0.3  (2.4) -1.4  (2.6)
9.Primary Outcome
Title Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52
Hide Description MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 5 6 6 6 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (1.9) -3.8  (6.4) -0.7  (2.7) -1.2  (5.6) -2.9  (1.3)
10.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of Bapineuzumab
Hide Description Participants who received bapineuzumab were reported.
Time Frame 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter (mcg/mL)
3.32  (0.857) 11.1  (1.16) 21.0  (0.968) 61.0  (32.8)
11.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab
Hide Description Participants who received bapineuzumab were reported.
Time Frame 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Median (Full Range)
Unit of Measure: hours
1.51
(1.08 to 3.91)
1.54
(1.00 to 5.86)
1.53
(1.00 to 2.00)
1.71
(0.45 to 5.95)
12.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab
Hide Description AUC is a measure of the serum concentration of the drug over time. AUC (0-t) is area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received bapineuzumab were reported.
Time Frame 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mcg*hour/mL
1260  (254) 4264  (462) 7818  (652) 15313  (8478)
13.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab
Hide Description AUC is a measure of the serum concentration of the drug over time. AUC (0 - ∞) is area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received bapineuzumab were reported.
Time Frame 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mcg*hour/mL
1279  (266) 4323  (456) 7884  (640) 15405  (8438)
14.Secondary Outcome
Title Systemic Clearance (CL) of Bapineuzumab
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received bapineuzumab were reported.
Time Frame 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL/hour
6.88  (1.32) 7.49  (1.71) 7.23  (1.49) 8.84  (3.97)
15.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) of Bapineuzumab
Hide Description Volume of distribution is defined as the theoretical blood volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Participants who received bapineuzumab were reported.
Time Frame 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL
5574  (906.5) 5947  (1406) 5827  (1611) 6879  (3132)
16.Secondary Outcome
Title Mean Residence Time of Bapineuzumab
Hide Description MRT is average time for which the drug molecules resides in the body, after administration. It is calculated as area under the serum concentration versus time first moment curve from time zero (pre-dose) to extrapolated infinite time (AUMC [0 - ∞]) divided by area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (AUC[0 - ∞]). AUMC (0-∞) is calculated as AUMC(0-inf)= AUMCt + [(t x Ct) / kel] + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method, Ct is the concentration at time t and kel is the terminal phase rate constant. Participants who received bapineuzumab were reported.
Time Frame 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: days
34.5  (7.0) 33.3  (4.4) 33.4  (5.2) 32.4  (4.6)
17.Secondary Outcome
Title Serum Decay Half-Life (t1/2) of Bapineuzumab
Hide Description Serum decay half-life is the time measured for the serum concentration to decrease by one half. Participants who received bapineuzumab were reported.
Time Frame 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: days
28.1  (5.9) 26.7  (1.8) 26.2  (3.4) 15.0  (9.9)
18.Secondary Outcome
Title Serum Bapineuzumab Concentrations
Hide Description Serum bapineuzumab concentration was determined by using a validated enzyme-linked immunosorbent assay (ELISA) method. Participants who received bapineuzumab were reported.
Time Frame 0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6, 24, 48, 168, 336, 672, 1008, 1344, 1848, 2184, 2688, 4368, 8736 hours post start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
0 Hour (n=0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
0.5 Hour (n=6,5,6,6) 1602  (464) 5211  (1025) 8158  (332) 29206  (26241)
1 Hour (n=6,6,6,6) 2970  (624) 10259  (1421) 19939  (868) 48995  (41719)
1.5 Hour (n=6,6,6,6) 3093  (696) 10861  (1398) 20423  (1559) 43798  (34612)
2 Hour (n=6,6,6,6) 2854  (726) 10362  (1473) 19200  (1333) 48008  (26387)
4 Hour (n=6,6,6,6) 2917  (1079) 10044  (1564) 17588  (1762) 32399  (14264)
6 Hour (n=6,6,6,6) 2678  (845) 9753  (1209) 18935  (1194) 34349  (14934)
24 Hour (n=6,6,6,6) 2276  (665) 7774  (1249) 12983  (224) 25567  (20599)
48 Hour (n=6,6,6,6) 1946  (379) 6423  (774) 12179  (372) 20575  (18648)
168 Hour (n=6,6,6,6) 1279  (225) 4431  (826) 8170  (369) 15925  (10963)
336 Hour (n=6,6,6,6) 911  (271) 3441  (344) 6374  (547) 12325  (5331)
672 Hour (n=6,6,6,6) 599  (80) 1940  (328) 3379  (1409) 6720  (4830)
1008 Hour (n=6,6,6,6) 384  (127) 1396  (326) 2295  (376) 5064  (2197)
1344 Hour (n=6,6,6,6) 267  (76) 811  (120) 1389  (318) 4440  (1755)
1848 Hour (n=6,6,6,6) 158  (61) 519  (126) 990  (312) 2172  (1289)
2184 Hour (n=6,6,4,6) 107  (49) 375  (95) 796  (126) 1386  (950)
2688 Hour (n=6,6,6,6) 69  (41) 221  (96) 468  (101) 595  (678)
4368 Hour (n=5,5,6,2) 14  (12) 46  (20) 70  (28) 25  (10)
8736 Hour (n=0,0,0,0) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Concentration was not estimable since no participant was evaluable.
19.Secondary Outcome
Title Number of Participants With Positive Serum Anti-Bapineuzumab Antibody
Hide Description Serum anti-bapineuzumab antibody concentration was determined by using a validated ELISA method.
Time Frame Baseline (Day 1) up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 8
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
20.Secondary Outcome
Title Plasma Amyloid-beta (x-40) Concentrations
Hide Description Amyloid-beta (A-beta) is a peptide fragment of the amyloid precursor protein which is one of the characteristic hallmarks of Alzheimer's disease (AD). Total plasma amyloid-beta (x-40) was determined using a validated ELISA method.
Time Frame 0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description:
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 8
Mean (Standard Deviation)
Unit of Measure: picogram per milliliter (pg/mL)
0 Hour (n=6,6,6,6,8) 309  (116) 298  (91) 276  (43) 339  (20) 281  (38)
1 Hour (n=6,5,5,6,8) 1009  (369) 1050  (142) 1593  (88) 1708  (247) 292  (48)
6 Hour (n=6,6,6,6,8) 1697  (871) 2664  (509) 3755  (356) 3905  (656) 293  (40)
24 Hour (n=6,6,6,6,8) 1474  (844) 3581  (660) 5333  (426) 7405  (1630) 302  (71)
336 Hour (n=6,6,6,6,8) 784  (320) 1675  (396) 3345  (485) 4325  (670) 279  (54)
1008 Hour (n=6,6,6,6,8) 543  (219) 985  (328) 1566  (281) 2664  (601) 287  (41)
2184 Hour (n=6,6,6,6,7) 331  (119) 488  (142) 668  (157) 1149  (432) 278  (59)
2688 Hour (n=6,6,6,6,7) 341  (108) 471  (114) 528  (128) 803  (268) 307  (81)
4368 Hour (n=5,6,6,6,7) 302  (86) 310  (74) 351  (33) 425  (68) 291  (71)
8736 Hour (n=5,6,6,6,7) 298  (107) 308  (29) 342  (41) 299  (22) 283  (42)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Hide Arm/Group Description Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1. Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1. Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1. Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1. Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
All-Cause Mortality
Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bapineuzumab 0.15 mg/kg Bapineuzumab 0.5 mg/kg Bapineuzumab 1.0 mg/kg Bapineuzumab 2.0 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   3/6 (50.00%)   6/6 (100.00%)   3/6 (50.00%)   7/8 (87.50%) 
Cardiac disorders           
Angina pectoris * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Ear and labyrinth disorders           
Vertigo * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%) 
Eye disorders           
Cataract * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/8 (12.50%) 
Glaucoma * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%) 
Gastrointestinal disorders           
Abdominal pain * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%) 
Abdominal pain upper * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%) 
Colonic polyp * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Haemorrhoids * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Periodontitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
General disorders           
Injection site haemorrhage * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Infections and infestations           
Abscess limb * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Cystitis * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Gastroenteritis * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%) 
Herpangina * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Nasopharyngitis * 1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  2/8 (25.00%) 
Oral herpes * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Pneumonia * 1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%) 
Tinea infection * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%) 
Injury, poisoning and procedural complications           
Spinal compression fracture * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Investigations           
Aspartate aminotransferase increased * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Blood alkaline phosphatase increased * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Blood pressure increased * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%) 
Back pain * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Muscle rigidity * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Muscle twitching * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/8 (12.50%) 
Musculoskeletal stiffness * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Skin papilloma * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%) 
Nervous system disorders           
Nystagmus * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Parkinsonism * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Psychiatric disorders           
Delirium * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Insomnia * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%) 
Renal and urinary disorders           
Dysuria * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Nocturia * 1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Reproductive system and breast disorders           
Benign prostatic hyperplasia * 1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma * 1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/8 (0.00%) 
Upper respiratory tract inflammation * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis contact * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Eczema * 1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Wyeth
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00397891    
Other Study ID Numbers: 3133K1-102
First Submitted: November 8, 2006
First Posted: November 10, 2006
Results First Submitted: August 20, 2014
Results First Posted: September 4, 2014
Last Update Posted: September 4, 2014