search
Back to results

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

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bapineuzumab 0.5 mg/kg
Bapineuzumab 1.0 m/kg
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring antibody

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bapineuzumab 0.5 mg/kg

Bapineuzumab 1.0 m/kg

Arm Description

bapineuzumab

bapineuzumab

Outcomes

Primary Outcome Measures

Number of Participants Reporting a Serious Adverse Event.
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.

Secondary Outcome Measures

Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at 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.
Change From Extension Study Baseline in ADAS-Cog/11 at 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.
Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at 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
Change From Extension Study Baseline in DAD Score at 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
Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at 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.
Change From Extension Study Baseline in NPI Score at 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.
Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at 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.
Change From Extension Study Baseline in MMSE Score at 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

Full Information

First Posted
October 14, 2009
Last Updated
November 12, 2013
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00996918
Brief Title
A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bapineuzumab 0.5 mg/kg
Arm Type
Experimental
Arm Description
bapineuzumab
Arm Title
Bapineuzumab 1.0 m/kg
Arm Type
Experimental
Arm Description
bapineuzumab
Intervention Type
Drug
Intervention Name(s)
Bapineuzumab 0.5 mg/kg
Other Intervention Name(s)
AAB-001
Intervention Description
Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Intervention Type
Drug
Intervention Name(s)
Bapineuzumab 1.0 m/kg
Other Intervention Name(s)
AAB-001
Intervention Description
I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Primary Outcome Measure Information:
Title
Number of Participants Reporting a Serious Adverse Event.
Description
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.
Time Frame
Up to Week 195
Secondary Outcome Measure Information:
Title
Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.
Description
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.
Time Frame
Weeks 13, 26, 39, 52 and 78
Title
Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.
Description
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.
Time Frame
Weeks 13, 26, 39, 52 and 78
Title
Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.
Description
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
Time Frame
Weeks 13, 26, 39, 52 and 78
Title
Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78
Description
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
Time Frame
Weeks 13, 26, 39, 52 and 78
Title
Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.
Description
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.
Time Frame
Weeks 26, 52 and 78
Title
Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.
Description
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.
Time Frame
Weeks 26, 52 and 78
Title
Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.
Description
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.
Time Frame
Weeks 6, 19, 32, 45 and 78
Title
Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.
Description
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
Time Frame
Weeks 6, 19, 32, 45 and 78

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Pfizer Investigational Site
City
Heidelberg Heights
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Pfizer Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Santiago
ZIP/Postal Code
7530193
Country
Chile
Facility Name
Pfizer Investigational Site
City
Santiago
ZIP/Postal Code
7630000
Country
Chile
Facility Name
Pfizer Investigational Site
City
Kuopio
ZIP/Postal Code
FIN-70210
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Pfizer Investigational Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13885
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Pfizer Investigational Site
City
Nantes - Saint Herblain
ZIP/Postal Code
44093
Country
France
Facility Name
Pfizer Investigational Site
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Pfizer Investigational Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Pfizer Investigational Site
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00179
Country
Italy
Facility Name
Pfizer Investigational Site
City
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nagano
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okayama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
's-Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
North Shore
State/Province
NZ
ZIP/Postal Code
622
Country
New Zealand
Facility Name
Pfizer Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Pfizer Investigational Site
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Pfizer Investigational Site
City
Poznan
ZIP/Postal Code
61-289
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Pfizer Investigational Site
City
Amadora
ZIP/Postal Code
2700-276
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1649-028
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
825 56
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Rimavska Sobota
ZIP/Postal Code
979 12
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Pfizer Investigational Site
City
Terrasa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Pfizer Investigational Site
City
Plasencia
State/Province
Caceres
ZIP/Postal Code
10600
Country
Spain
Facility Name
Pfizer Investigational Site
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Pfizer Investigational Site
City
Malmo
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Basel
State/Province
BS
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G20 OXA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Penarth
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
ZIP/Postal Code
S35 8QS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Swindon
ZIP/Postal Code
SN3 6BW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27334799
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3133K1-3002&StudyName=A%20Long-Term%20Safety%20And%20Tolerability%20Study%20Of%20Bapineuzumab%20In%20Alzheimer%20Disease%20Patients
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs