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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
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United States of America
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Alabama
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Arizona
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Georgia
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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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Vermont
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Wisconsin
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Cordoba
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Graz
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Kwa Zulu Natal
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Murcia
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Northampton
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Penarth
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Sheffield
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United Kingdom
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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