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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00998764




Registration number
NCT00998764
Ethics application status
Date submitted
16/10/2009
Date registered
20/10/2009
Date last updated
1/01/2016

Titles & IDs
Public title
A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
Scientific title
A Phase 3 Extension, Multicenter, Long Term Safety And Tolerability Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww.
Secondary ID [1] 0 0
B2521004
Secondary ID [2] 0 0
3133K1-3003
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

Experimental: Bapineuzumab 0.5 mg/kg -


Treatment: Drugs: Bapineuzumab 0.5 mg/kg
I.V., 0.5 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
Base Study Baseline, 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
Base Study Baseline, 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
Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Secondary outcome [4] 0 0
Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.
Timepoint [4] 0 0
Base Study Baseline, 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
Base Study Baseline, 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
Base Study Baseline, 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
Base Study Baseline, 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
Base Study Baseline, Weeks 6, 19, 32, 45 and 78

Eligibility
Key inclusion criteria
* Subject has completed study 3133K1-3001 (Week 78) 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
90 Years
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
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
494
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
Hornsby Hospital - Hornsby
Recruitment hospital [3] 0 0
Royal Adelaide Memory Trials Centre - Adelaide
Recruitment hospital [4] 0 0
Memory Unit 5C, Department of Neurology - Woodville South
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [6] 0 0
Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [7] 0 0
Hollywood Hospital; Pharmacy Dept - Nedlands
Recruitment hospital [8] 0 0
The McCusker Foundation for Alzheimer's Disease Research - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2207 - Hornsby
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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United States of America
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Illinois
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Louisiana
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Massachusetts
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Michigan
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Argentina
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Brugge
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Leuven
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Roeselare
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Chile
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Kuopio
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Turku
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Catania
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Roma
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Aichi
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Gauteng
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Kwa Zulu Natal
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Barcelona
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Caceres
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Burgos
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Madrid
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Murcia
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Sweden
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Malmo
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Sweden
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Uppsala
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Switzerland
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BS
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United Kingdom
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Sheffield
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Wales
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Bradford
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Brighton
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Glasgow
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London
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Newcastle upon Tyne
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Northampton
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Swindon
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United Kingdom
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Wakefield

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.
Trial website
https://clinicaltrials.gov/study/NCT00998764
Trial related presentations / publications
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.
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/study/NCT00998764