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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Stopped early
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
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Sheffield
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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/NCT00667810