Trial · NCT00676143

Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

NCT00676143, Phase 3, Terminated, Pfizer; results first posted 2016-06-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients. Trials, record NCT00676143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00676143

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
NCT number: NCT00676143
Status: Terminated
Phases: Phase 3
Enrollment: 1,100 participants, actual
Lead sponsor: Pfizer
Conditions: Alzheimer Disease
Interventions: bapineuzumab, placebo
First posted: 2008-05-12
Last updated: 2016-06-10
Other registries' IDs: eudract:2007-005995-14
Results first posted: 2016-06-10

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78	Baseline and 78 weeks	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.
Primary	Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78	Baseline and 78 weeks	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 psychometric 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.
Secondary	Change From Baseline in Brain Amyloid Burden at Week 71	Baseline and 71 weeks	Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PIB) positron emission tomography (PET). The latter is a semi-quantitative 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.
Secondary	Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71	Baseline and 71 Weeks	Biomarkers CSF phospho-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.
Secondary	Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71	Baseline and 71 Weeks	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.
Secondary	Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78	Week 39 to Week 78	Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. ADAS-Cog/11 total score range is 0 (least impairment) to 70 (most impairment); a negative treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 -month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.
Secondary	Divergence of Effect on the DAD Total Scores From Week 39 to Week 78	Week 39 to Week 78	Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. DAD total score range is 0 to 100; a positive treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 -month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.
Secondary	Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)	Baseline and 78 Weeks	The time to first median placebo deterioration, defined as the first time a participant experienced an increase (worsening) from baseline 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 median time to first median placebo deterioration was presented.
Secondary	Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)	Baseline and 78 Weeks	The time to first clinically meaningful deterioration was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of \>=7.
Secondary	Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)	Baseline and 78 Weeks	The time to first median placebo deterioration 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.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78	Baseline and 78 weeks	The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.	Unit on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78	Baseline and 78 weeks	The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.	Unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Brain Amyloid Burden at Week 71	Baseline and 71 weeks	PIB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one postbaseline PIB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI ≥1.35 at baseline.	standard uptake value ratio	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71	Baseline and 71 Weeks	CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).	pg/mL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71	Baseline and 71 Weeks	vMRI population included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.	Milliliter (mL)/year	LEAST_SQUARES_MEAN
SECONDARY	Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78	Week 39 to Week 78	The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.	Units/Year	LEAST_SQUARES_MEAN
SECONDARY	Divergence of Effect on the DAD Total Scores From Week 39 to Week 78	Week 39 to Week 78	The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.	Units/Year	LEAST_SQUARES_MEAN
SECONDARY	Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)	Baseline and 78 Weeks	The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.	Days	MEDIAN
SECONDARY	Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)	Baseline and 78 Weeks	The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.	Days	MEDIAN
SECONDARY	Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)	Baseline and 78 Weeks	The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.	Days	MEDIAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group54

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78	Placebo	7.31	Standard Error 0.47	Unit on a scale
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78	Bapineuzumab	7.32	Standard Error 0.39	Unit on a scale
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78	Placebo	-14.94	Standard Deviation 1.00	Unit on a scale
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78	Bapineuzumab	-14.89	Standard Deviation 0.84	Unit on a scale
Change From Baseline in Brain Amyloid Burden at Week 71	Placebo	0.03	Standard Error 0.04	standard uptake value ratio
Change From Baseline in Brain Amyloid Burden at Week 71	Bapineuzumab	-0.04	Standard Error 0.03	standard uptake value ratio
Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71	Placebo	0.83	Standard Error 2.04	pg/mL
Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71	Bapineuzumab	-0.55	Standard Error 1.84	pg/mL
Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71	Placebo	17.64	Standard Error 0.69	Milliliter (mL)/year
Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71	Bapineuzumab	17.51	Standard Error 0.56	Milliliter (mL)/year

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	441
Overall Study	STARTED	Bapineuzumab	658
Overall Study	Treated	Placebo	439
Overall Study	Treated	Bapineuzumab	654
Overall Study	COMPLETED	Placebo	285
Overall Study	COMPLETED	Bapineuzumab	398
Overall Study	NOT COMPLETED	Placebo	156
Overall Study	NOT COMPLETED	Bapineuzumab	260

Source ClinicalTrials.gov

Adverse events392

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Placebo	23	439	30
other	Diarrhoea	Gastrointestinal disorders	Bapineuzumab	34	654	38
other	Nasopharyngitis	Infections and infestations	Placebo	34	439	40
other	Nasopharyngitis	Infections and infestations	Bapineuzumab	45	654	66
other	Urinary tract infection	Infections and infestations	Placebo	24	439	37
other	Urinary tract infection	Infections and infestations	Bapineuzumab	30	654	34
other	Fall	Injury, poisoning and procedural complications	Placebo	27	439	36
other	Fall	Injury, poisoning and procedural complications	Bapineuzumab	39	654	47
other	Cerebral microhaemorrhage	Nervous system disorders	Placebo	16	439	38
other	Cerebral microhaemorrhage	Nervous system disorders	Bapineuzumab	76	654	218

1 to 10 of 392Source ClinicalTrials.gov

See all 392 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Bapineuzumab
Total, other adverse events	Placebo	198	439
Total, other adverse events	Bapineuzumab	298	654
Total, serious adverse events	Placebo	77	439
Total, serious adverse events	Bapineuzumab	137	654

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26297092	DERIVED	PubMed
27176461	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Bapineuzumab vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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