A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients

November 12, 2013 updated by: Pfizer

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

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 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Hornsby, New South Wales, Australia, 2077
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
      • Woodville South, South Australia, Australia, 5011
        • Pfizer Investigational Site
    • Victoria
      • Heidelberg Heights, Victoria, Australia, 3081
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Pfizer Investigational Site
  • Belgium
      • Antwerpen, Belgium, 2020
        • Pfizer Investigational Site
      • Brussels, Belgium, 1200
        • Pfizer Investigational Site
      • Edegem, Belgium, 2650
        • Pfizer Investigational Site
  • Chile
      • Santiago, Chile, 7530193
        • Pfizer Investigational Site
      • Santiago, Chile, 7630000
        • Pfizer Investigational Site
  • Finland
      • Kuopio, Finland, FIN-70210
        • Pfizer Investigational Site
      • Turku, Finland, 20520
        • Pfizer Investigational Site
  • France
      • Caen, France, 14033
        • Pfizer Investigational Site
      • Dijon, France, 21000
        • Pfizer Investigational Site
      • Lille, France, 59037
        • Pfizer Investigational Site
      • Marseille, France, 13000
        • Pfizer Investigational Site
      • Marseille, France, 13885
        • Pfizer Investigational Site
      • Montpellier, France, 34295
        • Pfizer Investigational Site
      • Nantes - Saint Herblain, France, 44093
        • Pfizer Investigational Site
      • Nice, France, 06000
        • Pfizer Investigational Site
      • Paris, France, 75013
        • Pfizer Investigational Site
      • Poitiers, France, 86021
        • Pfizer Investigational Site
      • Rennes, France, 35000
        • Pfizer Investigational Site
      • Rouen, France, 76031
        • Pfizer Investigational Site
      • Toulouse, France, 31059
        • Pfizer Investigational Site
  • Italy
      • Milano, Italy, 20133
        • Pfizer Investigational Site
      • Roma, Italy, 00179
        • Pfizer Investigational Site
  • Japan
      • Aichi, Japan
        • Pfizer Investigational Site
      • Chiba, Japan
        • Pfizer Investigational Site
      • Fukuoka, Japan
        • Pfizer Investigational Site
      • Hiroshima, Japan
        • Pfizer Investigational Site
      • Hyogo, Japan
        • Pfizer Investigational Site
      • Kagawa, Japan
        • Pfizer Investigational Site
      • Kanagawa, Japan
        • Pfizer Investigational Site
      • Kyoto, Japan
        • Pfizer Investigational Site
      • Nagano, Japan
        • Pfizer Investigational Site
      • Okayama, Japan
        • Pfizer Investigational Site
      • Osaka, Japan
        • Pfizer Investigational Site
      • Shizuoka, Japan
        • Pfizer Investigational Site
      • Tokyo, Japan
        • Pfizer Investigational Site
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 GZ
        • Pfizer Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • Pfizer Investigational Site
  • New Zealand
    • NZ
      • North Shore, NZ, New Zealand, 622
        • Pfizer Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Pfizer Investigational Site
      • Krakow, Poland, 31-531
        • Pfizer Investigational Site
      • Poznan, Poland, 61-289
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-097
        • Pfizer Investigational Site
      • Warszawa, Poland, 01-211
        • Pfizer Investigational Site
  • Portugal
      • Amadora, Portugal, 2700-276
        • Pfizer Investigational Site
      • Coimbra, Portugal, 3000-075
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1649-028
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 825 56
        • Pfizer Investigational Site
      • Rimavska Sobota, Slovakia, 979 12
        • Pfizer Investigational Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Pfizer Investigational Site
      • Pretoria, Gauteng, South Africa, 0081
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08003
        • Pfizer Investigational Site
      • Barcelona, Spain, 08014
        • Pfizer Investigational Site
      • Barcelona, Spain, 08041
        • Pfizer Investigational Site
      • Barcelona, Spain, 08034
        • Pfizer Investigational Site
      • Burgos, Spain, 09006
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Pfizer Investigational Site
    • Barcelona
      • Terrasa, Barcelona, Spain, 08221
        • Pfizer Investigational Site
    • Caceres
      • Plasencia, Caceres, Spain, 10600
        • Pfizer Investigational Site
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07014
        • Pfizer Investigational Site
      • Palma de Mallorca, Islas Baleares, Spain, 07010
        • Pfizer Investigational Site
  • Sweden
      • Malmo, Sweden, SE-205 02
        • Pfizer Investigational Site
  • Switzerland
    • BS
      • Basel, BS, Switzerland, CH-4031
        • Pfizer Investigational Site
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G20 OXA
        • Pfizer Investigational Site
      • London, United Kingdom, W6 8RF
        • Pfizer Investigational Site
      • London, United Kingdom, SE5 9RS
        • Pfizer Investigational Site
      • Newcastle upon Tyne, United Kingdom, NE4 5PL
        • Pfizer Investigational Site
      • Penarth, United Kingdom, CF64 2XX
        • Pfizer Investigational Site
      • Sheffield, United Kingdom, S10 2JF
        • Pfizer Investigational Site
      • Sheffield, United Kingdom, S35 8QS
        • Pfizer Investigational Site
      • Swindon, United Kingdom, SN3 6BW
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bapineuzumab 0.5 mg/kg
bapineuzumab
Drug: Bapineuzumab 0.5 mg/kg
Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Other Names:
  • AAB-001
Experimental: Bapineuzumab 1.0 m/kg
bapineuzumab
Drug: Bapineuzumab 1.0 m/kg
I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Other Names:
  • AAB-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting a Serious Adverse Event.
Time Frame: Up to Week 195
Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.
Up to Week 195

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.
Time Frame: Weeks 13, 26, 39, 52 and 78
The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.
Weeks 13, 26, 39, 52 and 78
Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.
Time Frame: Weeks 13, 26, 39, 52 and 78
The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.
Weeks 13, 26, 39, 52 and 78
Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.
Time Frame: Weeks 13, 26, 39, 52 and 78
The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement
Weeks 13, 26, 39, 52 and 78
Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78
Time Frame: Weeks 13, 26, 39, 52 and 78
The DAD measures instrumental and basic activities of daily living in participants with AD. The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement
Weeks 13, 26, 39, 52 and 78
Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.
Time Frame: Weeks 26, 52 and 78
NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.
Weeks 26, 52 and 78
Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.
Time Frame: Weeks 26, 52 and 78
NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.
Weeks 26, 52 and 78
Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.
Time Frame: Weeks 6, 19, 32, 45 and 78
MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.
Weeks 6, 19, 32, 45 and 78
Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.
Time Frame: Weeks 6, 19, 32, 45 and 78
MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state
Weeks 6, 19, 32, 45 and 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

January 1, 2014

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3133K1-3002
  • B2521003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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