A Long-Term Safety And Tolerability Extension Study 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
This study was conducted at 147 centers in 19 countries. The study was terminated early by the sponsor on 06 August 2012. Subjects who had not completed the final follow-up visit prior to 06 August 2012 were asked to complete an early termination 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/Bapineuzumab	Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by intravenous (IV) infusion approximately every 13 weeks up to week 195.
Bapineuzumab/Bapineuzumab	Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.

Participant Flow:   Overall Study

	Placebo/Bapineuzumab	Bapineuzumab/Bapineuzumab
STARTED	216	276
Treated	215	275
COMPLETED	0	2
NOT COMPLETED	216	274
Lack of Efficacy	3	6
Adverse Event	17	12
Withdrawal by Subject	19	25
Physician Decision	3	3
Death	3	1
Discontinuation of Study by Sponsor	164	217
Protocol Violation	0	1
Failed to Return	1	1
Lost to Follow-up	1	1
Loss of Caregiver	0	3
Not specified	4	4
Recurrent Episode of vasogenic edema	1	0

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.
The safety population included all participants who consented to participate in the extension and received at least one dose of the investigational product (in the extension study).

Reporting Groups

	Description
Placebo/Bapineuzumab	Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study Bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Bapineuzumab/Bapineuzumab	Participants received Bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
Total	Total of all reporting groups

Baseline Measures

	Placebo/Bapineuzumab	Bapineuzumab/Bapineuzumab	Total
Overall Participants Analyzed  [Units: Participants]	215	275	490
Age  [Units: Years] Mean (Standard Deviation)	71.4  (8.14)	72.1  (7.47)	71.8  (7.77)
Age, Customized  [Units: Participants]
< 65 years	44	42	86
>= 65 years	171	233	404
Gender  [Units: Participants]
Female	135	186	321
Male	80	89	169

1.  Primary:

Number of Participants Reporting a Serious Adverse Event   [ Time Frame: Up to Week 195 ]

2.  Secondary:

Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78   [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ]

3.  Secondary:

Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ]

4.  Secondary:

Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ]

5.  Secondary:

Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ]

6.  Secondary:

Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 26, 52 and 78 ]

7.  Secondary:

Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.   [ Time Frame: Base Study Baseline, Weeks 26, 52 and 78 ]

8.  Secondary:

Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.   [ Time Frame: Base Study Baseline, Weeks 6, 19, 32, 45 and 78 ]

9.  Secondary:

Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.   [ Time Frame: Base Study Baseline, Weeks 6, 19, 32, 45 and 78 ]

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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