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Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | bapineuzumab 0.15 mg/kg or placebo |
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| 2 | Experimental | bapineuzumab 0.5 mg/kg or placebo |
|
| 3 | Experimental | bapineuzumab 1.0 mg/kg or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bapineuzumab | Drug | The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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. | Baseline up to Week 52 |
| Number of Participants With Clinically Significant Changes in Physical Examinations | 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. | Screening up to Week 52 |
| Number of Participants With Vital Signs of Potential Clinical Importance | 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). | Baseline up to Week 52 |
| Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Bapineuzumab | Participants who received bapineuzumab were reported. | 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 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Chiba | Japan | ||||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26044070 | Derived | Arai H, Umemura K, Ichimiya Y, Iseki E, Eto K, Miyakawa K, Kirino E, Shibata N, Baba H, Tsuchiwata S. Safety and pharmacokinetics of bapineuzumab in a single ascending-dose study in Japanese patients with mild to moderate Alzheimer's disease. Geriatr Gerontol Int. 2016 May;16(5):644-50. doi: 10.1111/ggi.12516. Epub 2015 Jun 4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Bapineuzumab 0.5 mg/kg | Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1. |
| FG002 | Bapineuzumab 1.0 mg/kg | Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1. |
| FG003 | Bapineuzumab 2.0 mg/kg | Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1. |
| FG004 | Placebo | Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety data set included all randomized participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Bapineuzumab 0.5 mg/kg | Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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. | Safety data set included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Week 52 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Wyeth | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C545458 | bapineuzumab |
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|
| bapineuzumab | Drug | The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour. |
|
| bapineuzumab | Drug | The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour. |
|
| Screening up to Week 16 |
| Number of Participants With Laboratory Test Results of Potential Clinical Importance | 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). | Week 1 up to Week 52 |
| Number of Participants With Clinically Significant Changes in Neurological Examinations | Neurological examination included the assessment of mental status, cranial nerves, visual fields, sensory, motor, gait, primitive reflexes and tendon reflexes. | Screening up to Week 52 |
| Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6 | 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. | Baseline, Week 6 |
| Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16 | 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. | Baseline, Week 16 |
| Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52 | 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. | Baseline, Week 52 |
Participants who received bapineuzumab were reported. |
| 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 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab | 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. | 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 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab | 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. | 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 |
| Systemic Clearance (CL) of Bapineuzumab | CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received bapineuzumab were reported. | 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 |
| Volume of Distribution at Steady State (Vss) of Bapineuzumab | 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. | 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 |
| Mean Residence Time of Bapineuzumab | 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. | 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 |
| Serum Decay Half-Life (t1/2) of Bapineuzumab | Serum decay half-life is the time measured for the serum concentration to decrease by one half. Participants who received bapineuzumab were reported. | 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 |
| Serum Bapineuzumab Concentrations | Serum bapineuzumab concentration was determined by using a validated enzyme-linked immunosorbent assay (ELISA) method. Participants who received bapineuzumab were reported. | 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 |
| Number of Participants With Positive Serum Anti-Bapineuzumab Antibody | Serum anti-bapineuzumab antibody concentration was determined by using a validated ELISA method. | Baseline (Day 1) up to Week 52 |
| Plasma Amyloid-beta (x-40) Concentrations | 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. | 0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion |
| Saitama |
| Japan |
| Pfizer Investigational Site | Shizuoka | Japan |
| Pfizer Investigational Site | Tokyo | Japan |
| BG002 | Bapineuzumab 1.0 mg/kg | Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1. |
| BG003 | Bapineuzumab 2.0 mg/kg | Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1. |
| BG004 | Placebo | Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
| OG001 | Bapineuzumab 0.5 mg/kg | Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1. |
| OG002 | Bapineuzumab 1.0 mg/kg | Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1. |
| OG003 | Bapineuzumab 2.0 mg/kg | Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1. |
| OG004 | Placebo | Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1. |
|
|
| Primary | Number of Participants With Clinically Significant Changes in Physical Examinations | 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. | Safety data set included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Screening up to Week 52 |
|
|
|
| Primary | Number of Participants With Vital Signs of Potential Clinical Importance | 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). | Safety data set included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Week 52 |
|
|
|
| Primary | Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance | 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). | Safety data set included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Screening up to Week 16 |
|
|
|
| Primary | Number of Participants With Laboratory Test Results of Potential Clinical Importance | 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). | Safety data set included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Week 1 up to Week 52 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Neurological Examinations | Neurological examination included the assessment of mental status, cranial nerves, visual fields, sensory, motor, gait, primitive reflexes and tendon reflexes. | Safety data set included all randomized participants who received at least 1 dose of study medication. | Posted | Number | participants | Screening up to Week 52 |
|
|
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| Primary | Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6 | 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. | Safety data set included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 6 |
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| Primary | Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
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| Primary | Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Bapineuzumab | Participants who received bapineuzumab were reported. | 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. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | 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 |
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| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab | Participants who received bapineuzumab were reported. | 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. | Posted | Median | Full Range | hours | 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 |
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| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab | 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. | 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. | Posted | Mean | Standard Deviation | mcg*hour/mL | 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 |
|
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab | 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. | 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. | Posted | Mean | Standard Deviation | mcg*hour/mL | 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 |
|
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| Secondary | Systemic Clearance (CL) of Bapineuzumab | CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received bapineuzumab were reported. | 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. | Posted | Mean | Standard Deviation | mL/hour | 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 |
|
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| Secondary | Volume of Distribution at Steady State (Vss) of Bapineuzumab | 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. | 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. | Posted | Mean | Standard Deviation | mL | 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 |
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| Secondary | Mean Residence Time of Bapineuzumab | 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. | 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. | Posted | Mean | Standard Deviation | days | 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 |
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| Secondary | Serum Decay Half-Life (t1/2) of Bapineuzumab | Serum decay half-life is the time measured for the serum concentration to decrease by one half. Participants who received bapineuzumab were reported. | 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. | Posted | Mean | Standard Deviation | days | 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 |
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| Secondary | Serum Bapineuzumab Concentrations | Serum bapineuzumab concentration was determined by using a validated enzyme-linked immunosorbent assay (ELISA) method. Participants who received bapineuzumab were reported. | 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. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | 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 |
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| Secondary | Number of Participants With Positive Serum Anti-Bapineuzumab Antibody | Serum anti-bapineuzumab antibody concentration was determined by using a validated ELISA method. | 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. | Posted | Number | participants | Baseline (Day 1) up to Week 52 |
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| Secondary | Plasma Amyloid-beta (x-40) Concentrations | 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. | 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. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | 0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion |
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| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Bapineuzumab 0.5 mg/kg | Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1. | 0 | 6 | 3 | 6 |
| EG002 | Bapineuzumab 1.0 mg/kg | Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1. | 0 | 6 | 6 | 6 |
| EG003 | Bapineuzumab 2.0 mg/kg | Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1. | 0 | 6 | 3 | 6 |
| EG004 | Placebo | Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1. | 0 | 8 | 7 | 8 |
| Vertigo | Ear and labyrinth disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Colonic polyp | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Periodontitis | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Herpangina | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Tinea infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
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| Nystagmus | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Parkinsonism | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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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.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Change at Week 6 |
|
| 0.5 Hour (n=6,5,6,6) |
|
| 1 Hour (n=6,6,6,6) |
|
| 1.5 Hour (n=6,6,6,6) |
|
| 2 Hour (n=6,6,6,6) |
|
| 4 Hour (n=6,6,6,6) |
|
| 6 Hour (n=6,6,6,6) |
|
| 24 Hour (n=6,6,6,6) |
|
| 48 Hour (n=6,6,6,6) |
|
| 168 Hour (n=6,6,6,6) |
|
| 336 Hour (n=6,6,6,6) |
|
| 672 Hour (n=6,6,6,6) |
|
| 1008 Hour (n=6,6,6,6) |
|
| 1344 Hour (n=6,6,6,6) |
|
| 1848 Hour (n=6,6,6,6) |
|
| 2184 Hour (n=6,6,4,6) |
|
| 2688 Hour (n=6,6,6,6) |
|
| 4368 Hour (n=5,5,6,2) |
|
| 8736 Hour (n=0,0,0,0) |
|
| 1 Hour (n=6,5,5,6,8) |
|
| 6 Hour (n=6,6,6,6,8) |
|
| 24 Hour (n=6,6,6,6,8) |
|
| 336 Hour (n=6,6,6,6,8) |
|
| 1008 Hour (n=6,6,6,6,8) |
|
| 2184 Hour (n=6,6,6,6,7) |
|
| 2688 Hour (n=6,6,6,6,7) |
|
| 4368 Hour (n=5,6,6,6,7) |
|
| 8736 Hour (n=5,6,6,6,7) |
|