A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients

This study has been terminated.

(The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.)

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00998764

First received: October 16, 2009

Last updated: November 30, 2015

Last verified: November 2015

History of Changes

Results First Received: October 15, 2013

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Alzheimer Disease
Intervention:	Drug: Bapineuzumab 0.5 mg/kg

Participant Flow

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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

Baseline Characteristics

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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
Number of Participants [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

Outcome Measures

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1. Primary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00998764 History of Changes
Other Study ID Numbers:	3133K1-3003 B2521004 ( Other Identifier: Alias Study Number ) 2009-015080-13 ( EudraCT Number )
Study First Received:	October 16, 2009
Results First Received:	October 15, 2013
Last Updated:	November 30, 2015
Health Authority:	United States: Food and Drug Administration

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