Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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/ct2/show/NCT00667810




Registration number
NCT00667810
Ethics application status
Date submitted
24/04/2008
Date registered
28/04/2008
Date last updated
8/01/2016

Titles & IDs
Public title
Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
Scientific title
A Phase 3, 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 Non-carriers
Secondary ID [1] 0 0
B2521001
Secondary ID [2] 0 0
3133K1-3000
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 - bapineuzumab
Treatment: Drugs - placebo

Experimental: Bapineuzumab 0.5 mg/kg -

Experimental: Bapineuzumab 1.0 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: bapineuzumab
Bapineuzumab 1.0 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
The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78
Timepoint [1] 0 0
78 weeks
Primary outcome [2] 0 0
The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78
Timepoint [2] 0 0
78 weeks
Secondary outcome [1] 0 0
The Change From Baseline in Brain Amyloid Burden at Week 71.
Timepoint [1] 0 0
71 Weeks
Secondary outcome [2] 0 0
The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.
Timepoint [2] 0 0
71 Weeks
Secondary outcome [3] 0 0
The Change From Baseline in Brain Volume at Week 71
Timepoint [3] 0 0
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
39 Weeks
Secondary outcome [5] 0 0
Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
Timepoint [5] 0 0
39 weeks
Secondary outcome [6] 0 0
Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
Timepoint [6] 0 0
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
78 weeks
Secondary outcome [8] 0 0
Time to Median Placebo Deterioration on DAD Total Score
Timepoint [8] 0 0
78 Weeks
Secondary outcome [9] 0 0
Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)
Timepoint [9] 0 0
78 Weeks
Secondary outcome [10] 0 0
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)
Timepoint [10] 0 0
78 Weeks
Secondary outcome [11] 0 0
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
Timepoint [11] 0 0
78 Weeks
Secondary outcome [12] 0 0
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)
Timepoint [12] 0 0
78 Weeks
Secondary outcome [13] 0 0
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)
Timepoint [13] 0 0
78 weeks
Secondary outcome [14] 0 0
Change From Baseline in Dependence Scale Total Score at Week 78
Timepoint [14] 0 0
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
78 Weeks

Eligibility
Key inclusion criteria
- Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination
(MMSE) score of 16-26, and brain magnetic resonance imaging (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
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant neurological disease other than AD

- Major psychiatric disorder

- Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF)
shunt, or foreign metal objects in the body]

- Women 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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
901
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Hornsby Kuringai Hospital - Hornsby
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [4] 0 0
CDAMS Ballarat Base Hospital - Ballarat
Recruitment hospital [5] 0 0
Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit - West Heidelberg
Recruitment hospital [6] 0 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [7] 0 0
McCusker Alzheimer's Research Foundation Inc. - Nedlands
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide SA
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
02077 - Hornsby
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3353 - Ballarat
Recruitment postcode(s) [5] 0 0
3081 - West Heidelberg
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
5000 - Adelaide SA
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
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Vermont
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
Argentina
State/province [34] 0 0
Buenos Aires
Country [35] 0 0
Belgium
State/province [35] 0 0
Antwerpen
Country [36] 0 0
Belgium
State/province [36] 0 0
Brugge
Country [37] 0 0
Belgium
State/province [37] 0 0
Bruxelles
Country [38] 0 0
Belgium
State/province [38] 0 0
Edegem
Country [39] 0 0
Belgium
State/province [39] 0 0
Leuven
Country [40] 0 0
Belgium
State/province [40] 0 0
Roeselare
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Chile
State/province [43] 0 0
Santiago
Country [44] 0 0
Croatia
State/province [44] 0 0
Zagreb
Country [45] 0 0
Finland
State/province [45] 0 0
Kuopio
Country [46] 0 0
Finland
State/province [46] 0 0
Turku
Country [47] 0 0
France
State/province [47] 0 0
Cedex
Country [48] 0 0
France
State/province [48] 0 0
Amiens
Country [49] 0 0
France
State/province [49] 0 0
Bron
Country [50] 0 0
France
State/province [50] 0 0
Caen
Country [51] 0 0
France
State/province [51] 0 0
Colmar
Country [52] 0 0
France
State/province [52] 0 0
Dijon
Country [53] 0 0
France
State/province [53] 0 0
Lille
Country [54] 0 0
France
State/province [54] 0 0
Marseille
Country [55] 0 0
France
State/province [55] 0 0
Montpellier
Country [56] 0 0
France
State/province [56] 0 0
Nantes - Saint Herblain
Country [57] 0 0
France
State/province [57] 0 0
Nice
Country [58] 0 0
France
State/province [58] 0 0
Paris Cedex 13
Country [59] 0 0
France
State/province [59] 0 0
Paris
Country [60] 0 0
France
State/province [60] 0 0
Poitiers
Country [61] 0 0
France
State/province [61] 0 0
Reims
Country [62] 0 0
France
State/province [62] 0 0
Rouen
Country [63] 0 0
France
State/province [63] 0 0
Toulouse
Country [64] 0 0
Germany
State/province [64] 0 0
Berlin
Country [65] 0 0
Germany
State/province [65] 0 0
Bochum
Country [66] 0 0
Germany
State/province [66] 0 0
Offenburg
Country [67] 0 0
Germany
State/province [67] 0 0
Regensburg
Country [68] 0 0
Italy
State/province [68] 0 0
Ancona
Country [69] 0 0
Italy
State/province [69] 0 0
Brescia
Country [70] 0 0
Italy
State/province [70] 0 0
Catania
Country [71] 0 0
Italy
State/province [71] 0 0
Chieti
Country [72] 0 0
Italy
State/province [72] 0 0
Firenze
Country [73] 0 0
Italy
State/province [73] 0 0
Milano
Country [74] 0 0
Italy
State/province [74] 0 0
Monza
Country [75] 0 0
Italy
State/province [75] 0 0
Roma
Country [76] 0 0
Italy
State/province [76] 0 0
Siena
Country [77] 0 0
Japan
State/province [77] 0 0
Aichi,
Country [78] 0 0
Japan
State/province [78] 0 0
Tokyo
Country [79] 0 0
Japan
State/province [79] 0 0
Aichi
Country [80] 0 0
Japan
State/province [80] 0 0
Chiba
Country [81] 0 0
Japan
State/province [81] 0 0
Fukuoka
Country [82] 0 0
Japan
State/province [82] 0 0
Gunma
Country [83] 0 0
Japan
State/province [83] 0 0
Hiroshima
Country [84] 0 0
Japan
State/province [84] 0 0
Hyogo
Country [85] 0 0
Japan
State/province [85] 0 0
Iwate
Country [86] 0 0
Japan
State/province [86] 0 0
Kagawa
Country [87] 0 0
Japan
State/province [87] 0 0
Kanagawa
Country [88] 0 0
Japan
State/province [88] 0 0
Kyoto
Country [89] 0 0
Japan
State/province [89] 0 0
Nagano
Country [90] 0 0
Japan
State/province [90] 0 0
Niigata
Country [91] 0 0
Japan
State/province [91] 0 0
Okayama
Country [92] 0 0
Japan
State/province [92] 0 0
Osaka
Country [93] 0 0
Japan
State/province [93] 0 0
Shizuoka
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Gyeonggi-do
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Seoul
Country [96] 0 0
Mexico
State/province [96] 0 0
Nuevo León
Country [97] 0 0
Mexico
State/province [97] 0 0
Aguascalientes
Country [98] 0 0
Netherlands
State/province [98] 0 0
's-Hertogenbosch
Country [99] 0 0
Netherlands
State/province [99] 0 0
Amsterdam
Country [100] 0 0
Netherlands
State/province [100] 0 0
Breda
Country [101] 0 0
Netherlands
State/province [101] 0 0
Eindhoven
Country [102] 0 0
Netherlands
State/province [102] 0 0
Haarlem
Country [103] 0 0
Netherlands
State/province [103] 0 0
Leeuwarden
Country [104] 0 0
Netherlands
State/province [104] 0 0
s. Hertogenbosch
Country [105] 0 0
New Zealand
State/province [105] 0 0
NZ
Country [106] 0 0
New Zealand
State/province [106] 0 0
Christchurch
Country [107] 0 0
Poland
State/province [107] 0 0
Bydgoszcz
Country [108] 0 0
Poland
State/province [108] 0 0
Kielce
Country [109] 0 0
Poland
State/province [109] 0 0
Krakow
Country [110] 0 0
Poland
State/province [110] 0 0
Poznan
Country [111] 0 0
Poland
State/province [111] 0 0
Warszawa
Country [112] 0 0
Portugal
State/province [112] 0 0
Amadora
Country [113] 0 0
Portugal
State/province [113] 0 0
Coimbra
Country [114] 0 0
Portugal
State/province [114] 0 0
Lisboa
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Kazan
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Nizhny Novgorod
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Saint-Petersburg
Country [118] 0 0
Serbia
State/province [118] 0 0
Vojvodina
Country [119] 0 0
Serbia
State/province [119] 0 0
Belgrade
Country [120] 0 0
Serbia
State/province [120] 0 0
Beograd
Country [121] 0 0
Serbia
State/province [121] 0 0
Kragujevac
Country [122] 0 0
Slovakia
State/province [122] 0 0
Bratislava
Country [123] 0 0
Slovakia
State/province [123] 0 0
Martin
Country [124] 0 0
Slovakia
State/province [124] 0 0
Michalovce
Country [125] 0 0
Slovakia
State/province [125] 0 0
Rimavska Sobota
Country [126] 0 0
Slovakia
State/province [126] 0 0
Zilina
Country [127] 0 0
South Africa
State/province [127] 0 0
Gauteng
Country [128] 0 0
South Africa
State/province [128] 0 0
Kwa Zulu Natal
Country [129] 0 0
South Africa
State/province [129] 0 0
Western Cape
Country [130] 0 0
Spain
State/province [130] 0 0
Alicante
Country [131] 0 0
Spain
State/province [131] 0 0
Barcelona
Country [132] 0 0
Spain
State/province [132] 0 0
Caceres
Country [133] 0 0
Spain
State/province [133] 0 0
Islas Baleares
Country [134] 0 0
Spain
State/province [134] 0 0
Baracaldo
Country [135] 0 0
Spain
State/province [135] 0 0
Burgos
Country [136] 0 0
Spain
State/province [136] 0 0
Madrid
Country [137] 0 0
Spain
State/province [137] 0 0
Murcia
Country [138] 0 0
Sweden
State/province [138] 0 0
Malmo
Country [139] 0 0
Sweden
State/province [139] 0 0
Uppsala
Country [140] 0 0
Switzerland
State/province [140] 0 0
BS
Country [141] 0 0
Switzerland
State/province [141] 0 0
GE
Country [142] 0 0
Switzerland
State/province [142] 0 0
VD
Country [143] 0 0
Switzerland
State/province [143] 0 0
Thonex-Geneva
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Lancashire
Country [145] 0 0
United Kingdom
State/province [145] 0 0
West Yorkshire
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Brighton
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Glasgow
Country [148] 0 0
United Kingdom
State/province [148] 0 0
London
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Newcastle upon Tyne
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Northampton
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Penarth
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Sheffield
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Swindon

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in
patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab
or placebo. Each patient's participation will last approximately 1.5 years.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00667810
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00667810