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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00996918




Registration number
NCT00996918
Ethics application status
Date submitted
14/10/2009
Date registered
16/10/2009
Date last updated
1/01/2014

Titles & IDs
Public title
A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
Scientific title
A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety And Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Noncarriers And Participated In Study 3133K1-3000
Secondary ID [1] 0 0
B2521003
Secondary ID [2] 0 0
3133K1-3002
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 0.5 mg/kg
Treatment: Drugs - Bapineuzumab 1.0 m/kg

Experimental: Bapineuzumab 0.5 mg/kg - bapineuzumab

Experimental: Bapineuzumab 1.0 m/kg - bapineuzumab


Treatment: Drugs: Bapineuzumab 0.5 mg/kg
Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Treatment: Drugs: Bapineuzumab 1.0 m/kg
I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Reporting a Serious Adverse Event.
Timepoint [1] 0 0
Up to Week 195
Secondary outcome [1] 0 0
Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.
Timepoint [1] 0 0
Weeks 13, 26, 39, 52 and 78
Secondary outcome [2] 0 0
Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.
Timepoint [2] 0 0
Weeks 13, 26, 39, 52 and 78
Secondary outcome [3] 0 0
Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.
Timepoint [3] 0 0
Weeks 13, 26, 39, 52 and 78
Secondary outcome [4] 0 0
Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78
Timepoint [4] 0 0
Weeks 13, 26, 39, 52 and 78
Secondary outcome [5] 0 0
Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.
Timepoint [5] 0 0
Weeks 26, 52 and 78
Secondary outcome [6] 0 0
Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.
Timepoint [6] 0 0
Weeks 26, 52 and 78
Secondary outcome [7] 0 0
Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.
Timepoint [7] 0 0
Weeks 6, 19, 32, 45 and 78
Secondary outcome [8] 0 0
Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.
Timepoint [8] 0 0
Weeks 6, 19, 32, 45 and 78

Eligibility
Key inclusion criteria
* Subject has completed study 3133K1-3000 and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease
* Mini-Mental Status Examination (MMSE) >=10 at screening
* Caregiver able to attend all clinic visits with subject
Minimum age
51 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
* Any significant brain MRI abnormality.
* Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening

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
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
198
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Hornsby
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Woodville South
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Heidelberg Heights
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Edegem
Country [4] 0 0
Chile
State/province [4] 0 0
Santiago
Country [5] 0 0
Finland
State/province [5] 0 0
Kuopio
Country [6] 0 0
Finland
State/province [6] 0 0
Turku
Country [7] 0 0
France
State/province [7] 0 0
Caen
Country [8] 0 0
France
State/province [8] 0 0
Dijon
Country [9] 0 0
France
State/province [9] 0 0
Lille
Country [10] 0 0
France
State/province [10] 0 0
Marseille
Country [11] 0 0
France
State/province [11] 0 0
Montpellier
Country [12] 0 0
France
State/province [12] 0 0
Nantes - Saint Herblain
Country [13] 0 0
France
State/province [13] 0 0
Nice
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Poitiers
Country [16] 0 0
France
State/province [16] 0 0
Rennes
Country [17] 0 0
France
State/province [17] 0 0
Rouen
Country [18] 0 0
France
State/province [18] 0 0
Toulouse
Country [19] 0 0
Italy
State/province [19] 0 0
Milano
Country [20] 0 0
Italy
State/province [20] 0 0
Roma
Country [21] 0 0
Japan
State/province [21] 0 0
Aichi
Country [22] 0 0
Japan
State/province [22] 0 0
Chiba
Country [23] 0 0
Japan
State/province [23] 0 0
Fukuoka
Country [24] 0 0
Japan
State/province [24] 0 0
Hiroshima
Country [25] 0 0
Japan
State/province [25] 0 0
Hyogo
Country [26] 0 0
Japan
State/province [26] 0 0
Kagawa
Country [27] 0 0
Japan
State/province [27] 0 0
Kanagawa
Country [28] 0 0
Japan
State/province [28] 0 0
Kyoto
Country [29] 0 0
Japan
State/province [29] 0 0
Nagano
Country [30] 0 0
Japan
State/province [30] 0 0
Okayama
Country [31] 0 0
Japan
State/province [31] 0 0
Osaka
Country [32] 0 0
Japan
State/province [32] 0 0
Shizuoka
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Netherlands
State/province [34] 0 0
's-Hertogenbosch
Country [35] 0 0
Netherlands
State/province [35] 0 0
Leeuwarden
Country [36] 0 0
New Zealand
State/province [36] 0 0
NZ
Country [37] 0 0
Poland
State/province [37] 0 0
Bydgoszcz
Country [38] 0 0
Poland
State/province [38] 0 0
Krakow
Country [39] 0 0
Poland
State/province [39] 0 0
Poznan
Country [40] 0 0
Poland
State/province [40] 0 0
Warszawa
Country [41] 0 0
Portugal
State/province [41] 0 0
Amadora
Country [42] 0 0
Portugal
State/province [42] 0 0
Coimbra
Country [43] 0 0
Portugal
State/province [43] 0 0
Lisboa
Country [44] 0 0
Slovakia
State/province [44] 0 0
Bratislava
Country [45] 0 0
Slovakia
State/province [45] 0 0
Rimavska Sobota
Country [46] 0 0
South Africa
State/province [46] 0 0
Gauteng
Country [47] 0 0
Spain
State/province [47] 0 0
Alicante
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Caceres
Country [50] 0 0
Spain
State/province [50] 0 0
Islas Baleares
Country [51] 0 0
Spain
State/province [51] 0 0
Burgos
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Sweden
State/province [53] 0 0
Malmo
Country [54] 0 0
Switzerland
State/province [54] 0 0
BS
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Brighton
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Glasgow
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Newcastle upon Tyne
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Penarth
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Sheffield
Country [61] 0 0
United Kingdom
State/province [61] 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/NCT00996918