A Phase 3 interventional study of bapineuzumab and bapineuzumab in Alzheimer Disease, sponsored by Pfizer. Terminated at 348 sites in 26 countries. Open to participants aged 50 Years to 89 Years. Per ClinicalTrials.gov, last updated 2016-01-08.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 901 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: bapineuzumab
Drug: bapineuzumab
Drug: placebo
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Also known as: AAB-001
Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Also known as: AAB-001
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78
The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.
Time frame: 78 weeks
The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78
The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.
Time frame: 78 weeks
The Change From Baseline in Brain Amyloid Burden at Week 71.
Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.
Time frame: 71 Weeks
The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.
Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.
Time frame: 71 Weeks
The Change From Baseline in Brain Volume at Week 71
Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.
Time frame: 71 Weeks
Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.
Time frame: 39 Weeks
Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.
Time frame: 39 weeks
Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.
Time frame: 78 Weeks
Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)
The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of \>=7.
Time frame: 78 weeks
Time to Median Placebo Deterioration on DAD Total Score
The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.
Time frame: 78 Weeks
Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)
The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of \>=12.
Time frame: 78 Weeks
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)
Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.
Time frame: 78 Weeks
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is \<7.
Time frame: 78 Weeks
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)
Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.
Time frame: 78 Weeks
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)
Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was \<12.
Time frame: 78 weeks
Change From Baseline in Dependence Scale Total Score at Week 78
The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.
Time frame: 78 Weeks
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78
The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.
Time frame: 78 Weeks
The study was terminated on 06 August 2012 due to lack of clinical efficacy observed in completed studies ELN115727-301 (ApoE4 non-carriers) and ELN115727-302. A total of 329 participants had completed the study up to and including Week 78 before the decision was taken to terminate the study.
| Milestone | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo | Bapineuzumab 2.0 mg/kg |
|---|---|---|---|---|
| Started | 269 | 264 | 346 | 11 |
| Treated | 267 | 263 | 344 | 11 |
| Completed | 102 | 94 | 124 | 9 |
| Not completed | 167 | 170 | 222 | 2 |
| Withdrew: Adverse event | 13 | 14 | 19 | 1 |
| Withdrew: Death | 1 | 1 | 3 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 4 | 2 | 0 |
| Withdrew: Physician decision | 1 | 1 | 2 | 0 |
| Withdrew: Protocol violation | 0 | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 14 | 20 | 29 | 1 |
| Withdrew: Discontinuation of study by sponsor | 130 | 118 | 155 | 0 |
| Withdrew: Failed to return | 0 | 0 | 2 | 0 |
| Withdrew: Loss of caregiver | 0 | 1 | 3 | 0 |
| Withdrew: Vasogenic edema recurrence | 0 | 3 | 0 | 0 |
| Withdrew: Other | 6 | 6 | 5 | 0 |
The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.
| Units on a scale | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78 | 6.05 ± 0.71 | 8.07 ± 0.73 | 7.88 ± 0.64 |
The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.
| Units on a scale | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78 | -14.58 ± 1.50 | -15.07 ± 1.55 | -16.08 ± 1.36 |
Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.
| SUVr | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo | Pooled Bapineuzumab 0.5/1.0 mg/kg |
|---|---|---|---|---|
| The Change From Baseline in Brain Amyloid Burden at Week 71. | -0.04 ± 0.08 | 0.00 ± 0.05 | 0.02 ± 0.04 | -0.01 ± 0.04 |
Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.
| pg/mL | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo | Pooled Bapineuzumab 0.5/1.0 mg/kg |
|---|---|---|---|---|
| The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71. | -6.62 ± 3.90 | -6.35 ± 3.73 | 0.70 ± 3.03 | -6.48 ± 2.67 |
Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.
| mL/year | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| The Change From Baseline in Brain Volume at Week 71 | 18.55 ± 0.97 | 18.60 ± 1.00 | 17.54 ± 0.86 |
The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.
| Units/Year | Bapineuzumab 0.5 mg/kg - Placebo | Bapineuzumab 1.0 mg/kg - Placebo |
|---|---|---|
| Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78 | -1.32 ± 1.06 | 0.38 ± 1.09 |
The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.
| Units/Years | Bapineuzumab 0.5 mg/kg - Placebo | Bapineuzumab 1.0 mg/kg - Placebo |
|---|---|---|
| Divergence of Effect on the DAD Total Scores From Week 39 to Week 78 | 3.20 ± 2.22 | 2.01 ± 2.27 |
The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.
| Days | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan) | 546.0 (546.0 to NA) | 462.0 (455.0 to 546.0) | 540.0 (462.0 to 546.0) |
The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of \>=7.
| Days | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan) | 546.0 (546.0 to NA) | 546.0 (455.0 to 546.0) | 546.0 (476.0 to 546.0) |
The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.
| Days | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Time to Median Placebo Deterioration on DAD Total Score | 541.0 (455.0 to 546.0) | 534.0 (372.0 to NA) | 463.0 (453.0 to 546.0) |
The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of \>=12.
| Days | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan) | 542.0 (456.0 to 546.0) | 539.0 (450.0 to NA) | 540.0 (453.0 to 546.0) |
Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.
| Number of participants | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Worsening of 0 points | 10.6 (7.1 to 15.0) | 8.7 (5.5 to 12.9) | 7.3 (4.7 to 10.7) |
| Worsening of 3 points | 16.1 (11.8 to 21.2) | 13.4 (9.5 to 18.3) | 10.1 (7.0 to 13.8) |
| Worsening of 7 points | 23.1 (18.1 to 28.8) | 19.0 (14.3 to 24.4) | 19.2 (15.1 to 23.9) |
Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is \<7.
| Percentage of participants | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan) | 22.4 | 18.6 | 18.6 |
Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.
| Percentage of participants | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Worsening of 0 points | 10.2 (6.8 to 14.6) | 11.9 (8.1 to 16.5) | 9.1 (6.3 to 12.8) |
| Worsening of 6 points | 15.7 (11.4 to 20.7) | 16.6 (12.2 to 21.8) | 14.3 (10.7 to 18.6) |
| Worsening of 12 points | 20.0 (15.3 to 25.4) | 22.1 (17.2 to 27.8) | 19.5 (15.4 to 24.2) |
Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was \<12.
| Percentage of participants | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan) | 20.0 | 22.1 | 19.5 |
The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.
| Units on a scale | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Change From Baseline in Dependence Scale Total Score at Week 78 | 1.29 ± 0.19 | 1.16 ± 0.19 | 1.45 ± 0.17 |
The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.
| Units on a scale | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo |
|---|---|---|---|
| Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78 | 2.23 ± 0.23 | 2.41 ± 0.23 | 2.59 ± 0.20 |
Collected over 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bapineuzumab 0.5 mg/kg | — | 32/267 (12%) | 109/267 (40.8%) |
| Bapineuzumab 1.0 mg/kg | — | 34/263 (12.9%) | 123/263 (46.8%) |
| Placebo | — | 53/344 (15.4%) | 124/344 (36%) |
| Bapineuzumab 2.0 mg/kg | — | 2/11 (18.2%) | 9/11 (81.8%) |
| Event | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo | Bapineuzumab 2.0 mg/kg |
|---|---|---|---|---|
| Vasogenic cerebral oedemaNervous system disorders | 6/267 | 12/263 | 0/344 | 2/11 |
| Cerebral microhaemorrhageNervous system disorders | 0/267 | 1/263 | 0/344 | 1/11 |
| Confusional statePsychiatric disorders | 0/267 | 1/263 | 1/344 | 1/11 |
| Multiple injuriesInjury, poisoning and procedural complications | 2/267 | 0/263 | 0/344 | 0/11 |
| HeadacheNervous system disorders | 2/267 | 0/263 | 0/344 | 0/11 |
| FallInjury, poisoning and procedural complications | 0/267 | 1/263 | 2/344 | 0/11 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/267 | 1/263 | 2/344 | 0/11 |
| Colorectal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/267 | 0/263 | 2/344 | 0/11 |
| Rectal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/267 | 0/263 | 2/344 | 0/11 |
| ErythemaSkin and subcutaneous tissue disorders | 0/267 | 0/263 | 2/344 | 0/11 |
| Event | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo | Bapineuzumab 2.0 mg/kg |
|---|---|---|---|---|
| VomitingGastrointestinal disorders | 9/267 | 9/263 | 10/344 | 3/11 |
| NasopharyngitisInfections and infestations | 17/267 | 18/263 | 28/344 | 2/11 |
| ContusionInjury, poisoning and procedural complications | 6/267 | 8/263 | 1/344 | 2/11 |
| Blood pressure increasedInvestigations | 5/267 | 5/263 | 6/344 | 2/11 |
| HeadacheNervous system disorders | 17/267 | 15/263 | 29/344 | 2/11 |
| DepressionPsychiatric disorders | 13/267 | 11/263 | 9/344 | 2/11 |
| HypertensionVascular disorders | 8/267 | 10/263 | 9/344 | 2/11 |
| TachycardiaCardiac disorders | 0/267 | 0/263 | 2/344 | 1/11 |
| HypoacusisEar and labyrinth disorders | 0/267 | 0/263 | 0/344 | 1/11 |
| Vision blurredEye disorders | 0/267 | 1/263 | 1/344 | 1/11 |
Safety population included all randomized participants who received at least one infusion or portion of an infusion of study drug.
| Age, Continuous(Years) | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo | Bapineuzumab 2.0 mg/kg | Total |
|---|---|---|---|---|---|
| Mean | 71.4 ± 9.38 | 70.8 ± 9.73 | 69.9 ± 9.76 | 66.5 ± 7.94 | 70.6 ± 9.63 |
| Age, Customized(Years) | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo | Bapineuzumab 2.0 mg/kg | Total |
|---|---|---|---|---|---|
| <65 years | 73 | 81 | 115 | 6 | 275 |
| ≥65 years | 194 | 182 | 229 | 5 | 610 |
| Sex: Female, Male(Participants) | Bapineuzumab 0.5 mg/kg | Bapineuzumab 1.0 mg/kg | Placebo | Bapineuzumab 2.0 mg/kg | Total |
|---|---|---|---|---|---|
| Female | 151 | 150 | 199 | 4 | 504 |
| Male | 116 | 113 | 145 | 7 | 381 |
Showing the first 100 of 348 sites across 26 countries.
This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer