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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 218 centers across the world. The study was terminated early by the sponsor on 06 August 2012. Enrollment had already been completed at the time of this decision. Participants who were still participating at that time were asked to complete an early withdrawal visit.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
Bapineuzumab	Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks

Participant Flow:   Overall Study

	Placebo	Bapineuzumab
STARTED	441	658
Treated	439	654
COMPLETED	285	398
NOT COMPLETED	156	260
Adverse Event	34	60
Death	4	4
Lack of Efficacy	0	6
Lost to Follow-up	0	13
Physician Decision	5	8
Protocol Violation	4	8
Withdrawal by Subject	24	42
Discontinuation of study by sponsor	65	88
Failed to return	2	1
Loss of caregiver	5	3
Not specified	11	20
Participant participation unknown	1	4
Vasogenic edema recurrence	1	3

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all randomized participants who received at least one infusion or portion of an infusion of study drug.

Reporting Groups

	Description
Placebo	Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
Bapineuzumab	Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
Total	Total of all reporting groups

Baseline Measures

	Placebo	Bapineuzumab	Total
Overall Participants Analyzed  [Units: Participants]	439	654	1093
Age  [Units: Years] Mean (Standard Deviation)	70.3  (7.75)	71.0  (7.67)	70.7  (7.71)
Age, Customized  [Units: Number of participants]
<65 years	97	132	229
>=65 years	342	522	864
Gender  [Units: Number of participants]
Female	262	421	683
Male	177	233	410

1.  Primary:

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78   [ Time Frame: Baseline and 78 weeks ]

2.  Primary:

Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78   [ Time Frame: Baseline and 78 weeks ]

3.  Secondary:

Change From Baseline in Brain Amyloid Burden at Week 71   [ Time Frame: Baseline and 71 weeks ]

4.  Secondary:

Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71   [ Time Frame: Baseline and 71 Weeks ]

5.  Secondary:

Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71   [ Time Frame: Baseline and 71 Weeks ]

6.  Secondary:

Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78   [ Time Frame: Week 39 to Week 78 ]

7.  Secondary:

Divergence of Effect on the DAD Total Scores From Week 39 to Week 78   [ Time Frame: Week 39 to Week 78 ]

8.  Secondary:

Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

9.  Secondary:

Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

10.  Secondary:

Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

11.  Secondary:

Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)   [ Time Frame: Baseline and 78 Weeks ]

12.  Secondary:

Change From Baseline in Dependence Scale Total Score at Week 78   [ Time Frame: Baseline and 78 Weeks ]

13.  Secondary:

Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

14.  Secondary:

Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

15.  Secondary:

Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

16.  Secondary:

Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)   [ Time Frame: Baseline and 78 Weeks ]

17.  Secondary:

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78   [ Time Frame: Baseline and 78 Weeks ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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