Trial Outcomes & Findings for Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease (NCT NCT00397891)

NCT ID: NCT00397891

Last Updated: 2014-09-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 80 participants
• Primary outcome timeframe: Baseline up to Week 52
• Results posted on: 2014-09-04

Participant Flow

Participant milestones

Measure	Bapineuzumab 0.15 mg/kg Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Study STARTED	6	6	6	6	8
Overall Study COMPLETED	5	6	6	6	7
Overall Study NOT COMPLETED	1	0	0	0	1

Reasons for withdrawal

Measure	Bapineuzumab 0.15 mg/kg Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Overall Study Withdrawal by Subject	1	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.	Total n=32 Participants Total of all reporting groups
Age, Continuous	60.67 years STANDARD_DEVIATION 5.16 • n=5 Participants	72.17 years STANDARD_DEVIATION 8.38 • n=7 Participants	72.17 years STANDARD_DEVIATION 10.87 • n=5 Participants	64.83 years STANDARD_DEVIATION 5.19 • n=4 Participants	68.75 years STANDARD_DEVIATION 8.89 • n=21 Participants	67.78 years STANDARD_DEVIATION 8.72 • n=10 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	14 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	18 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 52

Population: Safety data set included all randomized participants who received at least 1 dose of study medication.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	5 participants	3 participants	6 participants	3 participants	7 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Screening up to Week 52

Population: Safety data set included all randomized participants who received at least 1 dose of study medication.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Number of Participants With Clinically Significant Changes in Physical Examinations	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline up to Week 52

Population: Safety data set included all randomized participants who received at least 1 dose of study medication.

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).

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Number of Participants With Vital Signs of Potential Clinical Importance	2 participants	0 participants	2 participants	1 participants	1 participants

PRIMARY outcome

Timeframe: Screening up to Week 16

Population: Safety data set included all randomized participants who received at least 1 dose of study medication.

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).

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance	0 participants	0 participants	0 participants	0 participants	1 participants

PRIMARY outcome

Timeframe: Week 1 up to Week 52

Population: Safety data set included all randomized participants who received at least 1 dose of study medication.

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).

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Number of Participants With Laboratory Test Results of Potential Clinical Importance	6 participants	4 participants	3 participants	5 participants	5 participants

PRIMARY outcome

Timeframe: Screening up to Week 52

Population: Safety data set included all randomized participants who received at least 1 dose of study medication.

Neurological examination included the assessment of mental status, cranial nerves, visual fields, sensory, motor, gait, primitive reflexes and tendon reflexes.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Number of Participants With Clinically Significant Changes in Neurological Examinations	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Safety data set included all randomized participants who received at least 1 dose of study medication.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6 Baseline	16.8 units on a scale Standard Deviation 2.9	21.0 units on a scale Standard Deviation 3.6	21.0 units on a scale Standard Deviation 4.6	20.2 units on a scale Standard Deviation 2.8	20.6 units on a scale Standard Deviation 3.0
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6 Change at Week 6	-0.2 units on a scale Standard Deviation 2.1	0.0 units on a scale Standard Deviation 2.3	-0.3 units on a scale Standard Deviation 3.0	-0.2 units on a scale Standard Deviation 3.8	-1.9 units on a scale Standard Deviation 3.1

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: 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.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=7 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16	0.2 units on a scale Standard Deviation 2.9	-0.7 units on a scale Standard Deviation 4.1	0.7 units on a scale Standard Deviation 2.4	-0.3 units on a scale Standard Deviation 2.4	-1.4 units on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: Baseline, Week 52

Population: 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.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=5 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=7 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52	-2.4 units on a scale Standard Deviation 1.9	-3.8 units on a scale Standard Deviation 6.4	-0.7 units on a scale Standard Deviation 2.7	-1.2 units on a scale Standard Deviation 5.6	-2.9 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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

Population: 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.

Participants who received bapineuzumab were reported.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Maximum Observed Serum Concentration (Cmax) of Bapineuzumab	3.32 microgram per milliliter (mcg/mL) Standard Deviation 0.857	11.1 microgram per milliliter (mcg/mL) Standard Deviation 1.16	21.0 microgram per milliliter (mcg/mL) Standard Deviation 0.968	61.0 microgram per milliliter (mcg/mL) Standard Deviation 32.8	—

SECONDARY outcome

Timeframe: 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

Population: 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.

Participants who received bapineuzumab were reported.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab	1.51 hours Interval 1.08 to 3.91	1.54 hours Interval 1.0 to 5.86	1.53 hours Interval 1.0 to 2.0	1.71 hours Interval 0.45 to 5.95	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab	1260 mcg*hour/mL Standard Deviation 254	4264 mcg*hour/mL Standard Deviation 462	7818 mcg*hour/mL Standard Deviation 652	15313 mcg*hour/mL Standard Deviation 8478	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab	1279 mcg*hour/mL Standard Deviation 266	4323 mcg*hour/mL Standard Deviation 456	7884 mcg*hour/mL Standard Deviation 640	15405 mcg*hour/mL Standard Deviation 8438	—

SECONDARY outcome

Timeframe: 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

Population: 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.

CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received bapineuzumab were reported.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Systemic Clearance (CL) of Bapineuzumab	6.88 mL/hour Standard Deviation 1.32	7.49 mL/hour Standard Deviation 1.71	7.23 mL/hour Standard Deviation 1.49	8.84 mL/hour Standard Deviation 3.97	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Volume of Distribution at Steady State (Vss) of Bapineuzumab	5574 mL Standard Deviation 906.5	5947 mL Standard Deviation 1406	5827 mL Standard Deviation 1611	6879 mL Standard Deviation 3132	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Mean Residence Time of Bapineuzumab	34.5 days Standard Deviation 7.0	33.3 days Standard Deviation 4.4	33.4 days Standard Deviation 5.2	32.4 days Standard Deviation 4.6	—

SECONDARY outcome

Timeframe: 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

Population: 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.

Serum decay half-life is the time measured for the serum concentration to decrease by one half. Participants who received bapineuzumab were reported.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Serum Decay Half-Life (t1/2) of Bapineuzumab	28.1 days Standard Deviation 5.9	26.7 days Standard Deviation 1.8	26.2 days Standard Deviation 3.4	15.0 days Standard Deviation 9.9	—

SECONDARY outcome

Timeframe: 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

Population: 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.

Serum bapineuzumab concentration was determined by using a validated enzyme-linked immunosorbent assay (ELISA) method. Participants who received bapineuzumab were reported.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Serum Bapineuzumab Concentrations 0 Hour (n=0,0,0,0)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Concentration was not estimable since no participant was evaluable.	NA nanogram per milliliter (ng/mL) Standard Deviation NA Concentration was not estimable since no participant was evaluable.	NA nanogram per milliliter (ng/mL) Standard Deviation NA Concentration was not estimable since no participant was evaluable.	NA nanogram per milliliter (ng/mL) Standard Deviation NA Concentration was not estimable since no participant was evaluable.	—
Serum Bapineuzumab Concentrations 0.5 Hour (n=6,5,6,6)	1602 nanogram per milliliter (ng/mL) Standard Deviation 464	5211 nanogram per milliliter (ng/mL) Standard Deviation 1025	8158 nanogram per milliliter (ng/mL) Standard Deviation 332	29206 nanogram per milliliter (ng/mL) Standard Deviation 26241	—
Serum Bapineuzumab Concentrations 1 Hour (n=6,6,6,6)	2970 nanogram per milliliter (ng/mL) Standard Deviation 624	10259 nanogram per milliliter (ng/mL) Standard Deviation 1421	19939 nanogram per milliliter (ng/mL) Standard Deviation 868	48995 nanogram per milliliter (ng/mL) Standard Deviation 41719	—
Serum Bapineuzumab Concentrations 1.5 Hour (n=6,6,6,6)	3093 nanogram per milliliter (ng/mL) Standard Deviation 696	10861 nanogram per milliliter (ng/mL) Standard Deviation 1398	20423 nanogram per milliliter (ng/mL) Standard Deviation 1559	43798 nanogram per milliliter (ng/mL) Standard Deviation 34612	—
Serum Bapineuzumab Concentrations 2 Hour (n=6,6,6,6)	2854 nanogram per milliliter (ng/mL) Standard Deviation 726	10362 nanogram per milliliter (ng/mL) Standard Deviation 1473	19200 nanogram per milliliter (ng/mL) Standard Deviation 1333	48008 nanogram per milliliter (ng/mL) Standard Deviation 26387	—
Serum Bapineuzumab Concentrations 4 Hour (n=6,6,6,6)	2917 nanogram per milliliter (ng/mL) Standard Deviation 1079	10044 nanogram per milliliter (ng/mL) Standard Deviation 1564	17588 nanogram per milliliter (ng/mL) Standard Deviation 1762	32399 nanogram per milliliter (ng/mL) Standard Deviation 14264	—
Serum Bapineuzumab Concentrations 6 Hour (n=6,6,6,6)	2678 nanogram per milliliter (ng/mL) Standard Deviation 845	9753 nanogram per milliliter (ng/mL) Standard Deviation 1209	18935 nanogram per milliliter (ng/mL) Standard Deviation 1194	34349 nanogram per milliliter (ng/mL) Standard Deviation 14934	—
Serum Bapineuzumab Concentrations 24 Hour (n=6,6,6,6)	2276 nanogram per milliliter (ng/mL) Standard Deviation 665	7774 nanogram per milliliter (ng/mL) Standard Deviation 1249	12983 nanogram per milliliter (ng/mL) Standard Deviation 224	25567 nanogram per milliliter (ng/mL) Standard Deviation 20599	—
Serum Bapineuzumab Concentrations 48 Hour (n=6,6,6,6)	1946 nanogram per milliliter (ng/mL) Standard Deviation 379	6423 nanogram per milliliter (ng/mL) Standard Deviation 774	12179 nanogram per milliliter (ng/mL) Standard Deviation 372	20575 nanogram per milliliter (ng/mL) Standard Deviation 18648	—
Serum Bapineuzumab Concentrations 168 Hour (n=6,6,6,6)	1279 nanogram per milliliter (ng/mL) Standard Deviation 225	4431 nanogram per milliliter (ng/mL) Standard Deviation 826	8170 nanogram per milliliter (ng/mL) Standard Deviation 369	15925 nanogram per milliliter (ng/mL) Standard Deviation 10963	—
Serum Bapineuzumab Concentrations 336 Hour (n=6,6,6,6)	911 nanogram per milliliter (ng/mL) Standard Deviation 271	3441 nanogram per milliliter (ng/mL) Standard Deviation 344	6374 nanogram per milliliter (ng/mL) Standard Deviation 547	12325 nanogram per milliliter (ng/mL) Standard Deviation 5331	—
Serum Bapineuzumab Concentrations 672 Hour (n=6,6,6,6)	599 nanogram per milliliter (ng/mL) Standard Deviation 80	1940 nanogram per milliliter (ng/mL) Standard Deviation 328	3379 nanogram per milliliter (ng/mL) Standard Deviation 1409	6720 nanogram per milliliter (ng/mL) Standard Deviation 4830	—
Serum Bapineuzumab Concentrations 1008 Hour (n=6,6,6,6)	384 nanogram per milliliter (ng/mL) Standard Deviation 127	1396 nanogram per milliliter (ng/mL) Standard Deviation 326	2295 nanogram per milliliter (ng/mL) Standard Deviation 376	5064 nanogram per milliliter (ng/mL) Standard Deviation 2197	—
Serum Bapineuzumab Concentrations 1344 Hour (n=6,6,6,6)	267 nanogram per milliliter (ng/mL) Standard Deviation 76	811 nanogram per milliliter (ng/mL) Standard Deviation 120	1389 nanogram per milliliter (ng/mL) Standard Deviation 318	4440 nanogram per milliliter (ng/mL) Standard Deviation 1755	—
Serum Bapineuzumab Concentrations 1848 Hour (n=6,6,6,6)	158 nanogram per milliliter (ng/mL) Standard Deviation 61	519 nanogram per milliliter (ng/mL) Standard Deviation 126	990 nanogram per milliliter (ng/mL) Standard Deviation 312	2172 nanogram per milliliter (ng/mL) Standard Deviation 1289	—
Serum Bapineuzumab Concentrations 2184 Hour (n=6,6,4,6)	107 nanogram per milliliter (ng/mL) Standard Deviation 49	375 nanogram per milliliter (ng/mL) Standard Deviation 95	796 nanogram per milliliter (ng/mL) Standard Deviation 126	1386 nanogram per milliliter (ng/mL) Standard Deviation 950	—
Serum Bapineuzumab Concentrations 2688 Hour (n=6,6,6,6)	69 nanogram per milliliter (ng/mL) Standard Deviation 41	221 nanogram per milliliter (ng/mL) Standard Deviation 96	468 nanogram per milliliter (ng/mL) Standard Deviation 101	595 nanogram per milliliter (ng/mL) Standard Deviation 678	—
Serum Bapineuzumab Concentrations 4368 Hour (n=5,5,6,2)	14 nanogram per milliliter (ng/mL) Standard Deviation 12	46 nanogram per milliliter (ng/mL) Standard Deviation 20	70 nanogram per milliliter (ng/mL) Standard Deviation 28	25 nanogram per milliliter (ng/mL) Standard Deviation 10	—
Serum Bapineuzumab Concentrations 8736 Hour (n=0,0,0,0)	NA nanogram per milliliter (ng/mL) Standard Deviation NA Concentration was not estimable since no participant was evaluable.	NA nanogram per milliliter (ng/mL) Standard Deviation NA Concentration was not estimable since no participant was evaluable.	NA nanogram per milliliter (ng/mL) Standard Deviation NA Concentration was not estimable since no participant was evaluable.	NA nanogram per milliliter (ng/mL) Standard Deviation NA Concentration was not estimable since no participant was evaluable.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 52

Population: 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.

Serum anti-bapineuzumab antibody concentration was determined by using a validated ELISA method.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Number of Participants With Positive Serum Anti-Bapineuzumab Antibody	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion

Population: 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.

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.

Outcome measures

Measure	Bapineuzumab 0.15 mg/kg n=6 Participants Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 Participants Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 Participants Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 Participants Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 Participants Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Plasma Amyloid-beta (x-40) Concentrations 0 Hour (n=6,6,6,6,8)	309 picogram per milliliter (pg/mL) Standard Deviation 116	298 picogram per milliliter (pg/mL) Standard Deviation 91	276 picogram per milliliter (pg/mL) Standard Deviation 43	339 picogram per milliliter (pg/mL) Standard Deviation 20	281 picogram per milliliter (pg/mL) Standard Deviation 38
Plasma Amyloid-beta (x-40) Concentrations 1 Hour (n=6,5,5,6,8)	1009 picogram per milliliter (pg/mL) Standard Deviation 369	1050 picogram per milliliter (pg/mL) Standard Deviation 142	1593 picogram per milliliter (pg/mL) Standard Deviation 88	1708 picogram per milliliter (pg/mL) Standard Deviation 247	292 picogram per milliliter (pg/mL) Standard Deviation 48
Plasma Amyloid-beta (x-40) Concentrations 6 Hour (n=6,6,6,6,8)	1697 picogram per milliliter (pg/mL) Standard Deviation 871	2664 picogram per milliliter (pg/mL) Standard Deviation 509	3755 picogram per milliliter (pg/mL) Standard Deviation 356	3905 picogram per milliliter (pg/mL) Standard Deviation 656	293 picogram per milliliter (pg/mL) Standard Deviation 40
Plasma Amyloid-beta (x-40) Concentrations 24 Hour (n=6,6,6,6,8)	1474 picogram per milliliter (pg/mL) Standard Deviation 844	3581 picogram per milliliter (pg/mL) Standard Deviation 660	5333 picogram per milliliter (pg/mL) Standard Deviation 426	7405 picogram per milliliter (pg/mL) Standard Deviation 1630	302 picogram per milliliter (pg/mL) Standard Deviation 71
Plasma Amyloid-beta (x-40) Concentrations 336 Hour (n=6,6,6,6,8)	784 picogram per milliliter (pg/mL) Standard Deviation 320	1675 picogram per milliliter (pg/mL) Standard Deviation 396	3345 picogram per milliliter (pg/mL) Standard Deviation 485	4325 picogram per milliliter (pg/mL) Standard Deviation 670	279 picogram per milliliter (pg/mL) Standard Deviation 54
Plasma Amyloid-beta (x-40) Concentrations 1008 Hour (n=6,6,6,6,8)	543 picogram per milliliter (pg/mL) Standard Deviation 219	985 picogram per milliliter (pg/mL) Standard Deviation 328	1566 picogram per milliliter (pg/mL) Standard Deviation 281	2664 picogram per milliliter (pg/mL) Standard Deviation 601	287 picogram per milliliter (pg/mL) Standard Deviation 41
Plasma Amyloid-beta (x-40) Concentrations 2184 Hour (n=6,6,6,6,7)	331 picogram per milliliter (pg/mL) Standard Deviation 119	488 picogram per milliliter (pg/mL) Standard Deviation 142	668 picogram per milliliter (pg/mL) Standard Deviation 157	1149 picogram per milliliter (pg/mL) Standard Deviation 432	278 picogram per milliliter (pg/mL) Standard Deviation 59
Plasma Amyloid-beta (x-40) Concentrations 2688 Hour (n=6,6,6,6,7)	341 picogram per milliliter (pg/mL) Standard Deviation 108	471 picogram per milliliter (pg/mL) Standard Deviation 114	528 picogram per milliliter (pg/mL) Standard Deviation 128	803 picogram per milliliter (pg/mL) Standard Deviation 268	307 picogram per milliliter (pg/mL) Standard Deviation 81
Plasma Amyloid-beta (x-40) Concentrations 4368 Hour (n=5,6,6,6,7)	302 picogram per milliliter (pg/mL) Standard Deviation 86	310 picogram per milliliter (pg/mL) Standard Deviation 74	351 picogram per milliliter (pg/mL) Standard Deviation 33	425 picogram per milliliter (pg/mL) Standard Deviation 68	291 picogram per milliliter (pg/mL) Standard Deviation 71
Plasma Amyloid-beta (x-40) Concentrations 8736 Hour (n=5,6,6,6,7)	298 picogram per milliliter (pg/mL) Standard Deviation 107	308 picogram per milliliter (pg/mL) Standard Deviation 29	342 picogram per milliliter (pg/mL) Standard Deviation 41	299 picogram per milliliter (pg/mL) Standard Deviation 22	283 picogram per milliliter (pg/mL) Standard Deviation 42

Adverse Events

Bapineuzumab 0.15 mg/kg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Bapineuzumab 0.5 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Bapineuzumab 1.0 mg/kg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Bapineuzumab 2.0 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bapineuzumab 0.15 mg/kg n=6 participants at risk Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.	Bapineuzumab 0.5 mg/kg n=6 participants at risk Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 1.0 mg/kg n=6 participants at risk Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.	Bapineuzumab 2.0 mg/kg n=6 participants at risk Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.	Placebo n=8 participants at risk Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
Cardiac disorders Angina pectoris	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Ear and labyrinth disorders Vertigo	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/8 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.
Eye disorders Cataract	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Eye disorders Glaucoma	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Gastrointestinal disorders Colonic polyp	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Gastrointestinal disorders Periodontitis	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
General disorders Injection site haemorrhage	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Infections and infestations Abscess limb	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Infections and infestations Cystitis	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Infections and infestations Gastroenteritis	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Infections and infestations Herpangina	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Infections and infestations Nasopharyngitis	16.7% 1/6 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.	16.7% 1/6 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.	16.7% 1/6 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.	16.7% 1/6 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.	25.0% 2/8 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.
Infections and infestations Oral herpes	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Infections and infestations Pneumonia	0.00% 0/6 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.	16.7% 1/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Infections and infestations Tinea infection	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/8 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.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Investigations Aspartate aminotransferase increased	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Investigations Blood alkaline phosphatase increased	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Investigations Blood pressure increased	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Musculoskeletal and connective tissue disorders Muscle rigidity	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	12.5% 1/8 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.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Nervous system disorders Nystagmus	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Nervous system disorders Parkinsonism	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Psychiatric disorders Delirium	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Psychiatric disorders Insomnia	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/8 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.
Renal and urinary disorders Dysuria	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Renal and urinary disorders Nocturia	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/6 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.	0.00% 0/8 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	16.7% 1/6 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.	0.00% 0/8 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.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	0.00% 0/6 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.	12.5% 1/8 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Wyeth

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER