Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00676143




Registration number
NCT00676143
Ethics application status
Date submitted
2/05/2008
Date registered
12/05/2008
Date last updated
10/06/2016

Titles & IDs
Public title
Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
Scientific title
A Phase Iii, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy And Safety Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Carriers
Secondary ID [1] 0 0
B2521002
Secondary ID [2] 0 0
3133K1-3001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bapineuzumab
Treatment: Drugs - placebo

Experimental: Bapineuzumab 0.5 mg/kg -

Placebo comparator: Placebo -


Treatment: Drugs: bapineuzumab
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.

Treatment: Drugs: placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78
Timepoint [1] 0 0
Baseline and 78 weeks
Primary outcome [2] 0 0
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78
Timepoint [2] 0 0
Baseline and 78 weeks
Secondary outcome [1] 0 0
Change From Baseline in Brain Amyloid Burden at Week 71
Timepoint [1] 0 0
Baseline and 71 weeks
Secondary outcome [2] 0 0
Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71
Timepoint [2] 0 0
Baseline and 71 Weeks
Secondary outcome [3] 0 0
Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71
Timepoint [3] 0 0
Baseline and 71 Weeks
Secondary outcome [4] 0 0
Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
Timepoint [4] 0 0
Week 39 to Week 78
Secondary outcome [5] 0 0
Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
Timepoint [5] 0 0
Week 39 to Week 78
Secondary outcome [6] 0 0
Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
Timepoint [6] 0 0
Baseline and 78 Weeks
Secondary outcome [7] 0 0
Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)
Timepoint [7] 0 0
Baseline and 78 Weeks
Secondary outcome [8] 0 0
Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)
Timepoint [8] 0 0
Baseline and 78 Weeks
Secondary outcome [9] 0 0
Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)
Timepoint [9] 0 0
Baseline and 78 Weeks
Secondary outcome [10] 0 0
Change From Baseline in Dependence Scale Total Score at Week 78
Timepoint [10] 0 0
Baseline and 78 Weeks
Secondary outcome [11] 0 0
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)
Timepoint [11] 0 0
Baseline and 78 Weeks
Secondary outcome [12] 0 0
Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
Timepoint [12] 0 0
Baseline and 78 Weeks
Secondary outcome [13] 0 0
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)
Timepoint [13] 0 0
Baseline and 78 Weeks
Secondary outcome [14] 0 0
Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)
Timepoint [14] 0 0
Baseline and 78 Weeks
Secondary outcome [15] 0 0
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78
Timepoint [15] 0 0
Baseline and 78 Weeks

Eligibility
Key inclusion criteria
* Diagnosis of probable AD, with MMSE score of 16-26, and brain MRI consistent with the diagnosis of AD
* Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.
* Caregiver will participate and be able to attend clinic visits with patient.
Minimum age
50 Years
Maximum age
88 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant neurological disease other than AD, or a major psychiatric disorder
* Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
* Woman of childbearing potential

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
1100
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital; Pharmacy Dept - Gosford
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
Hornsby Kuringai Hospital - Hornsby
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [6] 0 0
CDAMS Ballarat Base Hospital - Ballarat
Recruitment hospital [7] 0 0
Heidelberg Repatriation Hospital - West Heidelberg
Recruitment hospital [8] 0 0
Hollywood Hospital; Pharmacy Dept - Nedlands
Recruitment hospital [9] 0 0
McCusker Alzheimer's Research Foundation, Inc. - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2077 - Hornsby
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3353 - Ballarat
Recruitment postcode(s) [6] 0 0
3081 - West Heidelberg
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Rhode Island
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Vermont
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Argentina
State/province [27] 0 0
Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordoba
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Austria
State/province [30] 0 0
Klagenfurt
Country [31] 0 0
Austria
State/province [31] 0 0
Wien
Country [32] 0 0
Belgium
State/province [32] 0 0
Antwerpen
Country [33] 0 0
Belgium
State/province [33] 0 0
Brugge
Country [34] 0 0
Belgium
State/province [34] 0 0
Brussels
Country [35] 0 0
Belgium
State/province [35] 0 0
Edegem
Country [36] 0 0
Belgium
State/province [36] 0 0
Leuven
Country [37] 0 0
Belgium
State/province [37] 0 0
Roeselare
Country [38] 0 0
Chile
State/province [38] 0 0
Santiago
Country [39] 0 0
Croatia
State/province [39] 0 0
Zagreb
Country [40] 0 0
Finland
State/province [40] 0 0
Kuopio
Country [41] 0 0
Finland
State/province [41] 0 0
Turku
Country [42] 0 0
France
State/province [42] 0 0
Bordeaux Cedex
Country [43] 0 0
France
State/province [43] 0 0
Bron
Country [44] 0 0
France
State/province [44] 0 0
Caen
Country [45] 0 0
France
State/province [45] 0 0
Colmar
Country [46] 0 0
France
State/province [46] 0 0
Dijon
Country [47] 0 0
France
State/province [47] 0 0
Lille
Country [48] 0 0
France
State/province [48] 0 0
Marseille
Country [49] 0 0
France
State/province [49] 0 0
Montpellier
Country [50] 0 0
France
State/province [50] 0 0
Nantes - Saint Herblain
Country [51] 0 0
France
State/province [51] 0 0
Nice
Country [52] 0 0
France
State/province [52] 0 0
Paris
Country [53] 0 0
France
State/province [53] 0 0
Poitiers
Country [54] 0 0
France
State/province [54] 0 0
Reims
Country [55] 0 0
France
State/province [55] 0 0
Rennes Cedex
Country [56] 0 0
France
State/province [56] 0 0
Rouen
Country [57] 0 0
France
State/province [57] 0 0
Toulouse
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Bochum
Country [60] 0 0
Germany
State/province [60] 0 0
Dresden
Country [61] 0 0
Germany
State/province [61] 0 0
Freiburg
Country [62] 0 0
Germany
State/province [62] 0 0
Offenburg
Country [63] 0 0
Germany
State/province [63] 0 0
Ulm
Country [64] 0 0
Italy
State/province [64] 0 0
Ancona
Country [65] 0 0
Italy
State/province [65] 0 0
Brescia
Country [66] 0 0
Italy
State/province [66] 0 0
Catania
Country [67] 0 0
Italy
State/province [67] 0 0
Chieti
Country [68] 0 0
Italy
State/province [68] 0 0
Milano
Country [69] 0 0
Italy
State/province [69] 0 0
Monza
Country [70] 0 0
Italy
State/province [70] 0 0
Roma
Country [71] 0 0
Italy
State/province [71] 0 0
Siena
Country [72] 0 0
Japan
State/province [72] 0 0
Aichi,
Country [73] 0 0
Japan
State/province [73] 0 0
Tokyo
Country [74] 0 0
Japan
State/province [74] 0 0
Aichi
Country [75] 0 0
Japan
State/province [75] 0 0
Chiba
Country [76] 0 0
Japan
State/province [76] 0 0
Fukuoka
Country [77] 0 0
Japan
State/province [77] 0 0
Gunma
Country [78] 0 0
Japan
State/province [78] 0 0
Hiroshima
Country [79] 0 0
Japan
State/province [79] 0 0
Hyogo
Country [80] 0 0
Japan
State/province [80] 0 0
Iwate
Country [81] 0 0
Japan
State/province [81] 0 0
Kagawa
Country [82] 0 0
Japan
State/province [82] 0 0
Kanagawa
Country [83] 0 0
Japan
State/province [83] 0 0
Kyoto
Country [84] 0 0
Japan
State/province [84] 0 0
Nagano
Country [85] 0 0
Japan
State/province [85] 0 0
Niigata
Country [86] 0 0
Japan
State/province [86] 0 0
Okayama
Country [87] 0 0
Japan
State/province [87] 0 0
Osaka
Country [88] 0 0
Japan
State/province [88] 0 0
Shizuoka
Country [89] 0 0
Mexico
State/province [89] 0 0
Nuevo León
Country [90] 0 0
Mexico
State/province [90] 0 0
Aguascalientes
Country [91] 0 0
Netherlands
State/province [91] 0 0
Noord Brabant
Country [92] 0 0
Netherlands
State/province [92] 0 0
Noord Holland
Country [93] 0 0
Netherlands
State/province [93] 0 0
The Netherlands
Country [94] 0 0
Netherlands
State/province [94] 0 0
's-Hertogenbosch
Country [95] 0 0
Netherlands
State/province [95] 0 0
Alkmaar
Country [96] 0 0
Netherlands
State/province [96] 0 0
Amsterdam
Country [97] 0 0
Netherlands
State/province [97] 0 0
Eindhoven
Country [98] 0 0
Netherlands
State/province [98] 0 0
Leeuwarden
Country [99] 0 0
Netherlands
State/province [99] 0 0
Rotterdam
Country [100] 0 0
New Zealand
State/province [100] 0 0
NZ
Country [101] 0 0
New Zealand
State/province [101] 0 0
Christchurch
Country [102] 0 0
Poland
State/province [102] 0 0
Bydgoszcz
Country [103] 0 0
Poland
State/province [103] 0 0
Krakow
Country [104] 0 0
Poland
State/province [104] 0 0
Poznan
Country [105] 0 0
Poland
State/province [105] 0 0
Warszawa
Country [106] 0 0
Portugal
State/province [106] 0 0
Amadora
Country [107] 0 0
Portugal
State/province [107] 0 0
Coimbra
Country [108] 0 0
Portugal
State/province [108] 0 0
Lisboa
Country [109] 0 0
Serbia
State/province [109] 0 0
Belgrade
Country [110] 0 0
Serbia
State/province [110] 0 0
Kragujevac
Country [111] 0 0
Serbia
State/province [111] 0 0
Novi Sad
Country [112] 0 0
Serbia
State/province [112] 0 0
Sremska Kamenica
Country [113] 0 0
Slovakia
State/province [113] 0 0
Bratislava
Country [114] 0 0
Slovakia
State/province [114] 0 0
Michalovce
Country [115] 0 0
Slovakia
State/province [115] 0 0
Rimavska Sobota
Country [116] 0 0
South Africa
State/province [116] 0 0
Gauteng
Country [117] 0 0
South Africa
State/province [117] 0 0
Kwa Zulu Natal
Country [118] 0 0
South Africa
State/province [118] 0 0
Western Cape
Country [119] 0 0
Spain
State/province [119] 0 0
Alicante
Country [120] 0 0
Spain
State/province [120] 0 0
Barcelona
Country [121] 0 0
Spain
State/province [121] 0 0
Caceres
Country [122] 0 0
Spain
State/province [122] 0 0
Islas Baleares
Country [123] 0 0
Spain
State/province [123] 0 0
Pais Vasco
Country [124] 0 0
Spain
State/province [124] 0 0
Vizcalla
Country [125] 0 0
Spain
State/province [125] 0 0
Burgos
Country [126] 0 0
Spain
State/province [126] 0 0
Madrid
Country [127] 0 0
Spain
State/province [127] 0 0
Murcia
Country [128] 0 0
Sweden
State/province [128] 0 0
Malmo
Country [129] 0 0
Sweden
State/province [129] 0 0
Uppsala
Country [130] 0 0
Switzerland
State/province [130] 0 0
BS
Country [131] 0 0
Switzerland
State/province [131] 0 0
GE
Country [132] 0 0
Switzerland
State/province [132] 0 0
VD
Country [133] 0 0
Switzerland
State/province [133] 0 0
Thonex-Geneva
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Lancashire
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Manchester
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Bradford
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Brighton
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Glasgow
Country [139] 0 0
United Kingdom
State/province [139] 0 0
London
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Newcastle upon Tyne
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Northampton
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Penarth
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Sheffield
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Swindon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00676143