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

NCT ID: NCT00996918

Last Updated: 2014-01-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bapineuzumab 0.5 mg/kg

bapineuzumab

Group Type EXPERIMENTAL

Bapineuzumab 0.5 mg/kg

Intervention Type DRUG

Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Bapineuzumab 1.0 m/kg

bapineuzumab

Group Type EXPERIMENTAL

Bapineuzumab 1.0 m/kg

Intervention Type DRUG

I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Interventions

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Bapineuzumab 0.5 mg/kg

Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Intervention Type DRUG

Bapineuzumab 1.0 m/kg

I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Intervention Type DRUG

Other Intervention Names

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AAB-001 AAB-001

Eligibility Criteria

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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
Minimum Eligible Age

51 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hornsby, New South Wales, Australia

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Adelaide, South Australia, Australia

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Woodville South, South Australia, Australia

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Heidelberg Heights, Victoria, Australia

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Nedlands, Western Australia, Australia

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Antwerp, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Santiago, Chile, Chile

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Santiago, Chile, Chile

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Kuopio, , Finland

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Turku, , Finland

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Dijon, France, France

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Lille, France, France

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Marseille, France, France

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Paris, France, France

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Caen, , France

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Marseille, , France

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Montpellier, , France

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Nantes - Saint Herblain, , France

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Nice, , France

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Poitiers, , France

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Rennes, , France

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Rouen, , France

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Toulouse, , France

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Milan, , Italy

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Roma, , Italy

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Aichi, , Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Hiroshima, , Japan

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Hyōgo, , Japan

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Kagawa, , Japan

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Kanagawa, , Japan

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Kyoto, , Japan

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Nagano, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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's-Hertogenbosch, , Netherlands

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Leeuwarden, , Netherlands

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North Shore, NZ, New Zealand

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Poznan, Poland, Poland

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Bydgoszcz, , Poland

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Krakow, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Amadora, Amadora, Portugal

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Coimbra, Coimbra District, Portugal

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Lisbon, Lisbon District, Portugal

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Bratislava, , Slovakia

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Rimavská Sobota, , Slovakia

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Elche, Alicante, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Terrassa, Barcelona, Spain

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Burgos, Burgos, Spain

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Plasencia, Caceres, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, , Spain

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Malmo, , Sweden

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Basel, Canton of Basel-City, Switzerland

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London, London, United Kingdom

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Brighton, , United Kingdom

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Glasgow, , United Kingdom

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London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Penarth, , United Kingdom

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Sheffield, , United Kingdom

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Sheffield, , United Kingdom

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Swindon, , United Kingdom

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Countries

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Australia Belgium Chile Finland France Italy Japan Netherlands New Zealand Poland Portugal Slovakia South Africa Spain Sweden Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27334799 (View on PubMed)

Related Links

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Other Identifiers

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B2521003

Identifier Type: -

Identifier Source: secondary_id

3133K1-3002

Identifier Type: -

Identifier Source: org_study_id

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