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

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NCT00996918

Last updated on March 31, 2020
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Study Location
Pfizer Investigational Site
Hornsby, New South Wales, 2077 Australia
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
51 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00996918
Pfizer
Terminated
A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients

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Descriptive Information
Brief Title  ICMJE A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Bapineuzumab 0.5 mg/kg
    Bapineuzumab I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
    Other Name: AAB-001
  • Drug: Bapineuzumab 1.0 m/kg
    I.V., 1.0 mg/kg, infusion every 13 weeks for a total of 16 infusions.
    Other Name: AAB-001
Study Arms  ICMJE
  • Experimental: Bapineuzumab 0.5 mg/kg
    bapineuzumab
    Intervention: Drug: Bapineuzumab 0.5 mg/kg
  • Experimental: Bapineuzumab 1.0 m/kg
    bapineuzumab
    Intervention: Drug: Bapineuzumab 1.0 m/kg
Publications * 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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 12, 2012) 		198
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2009) 		1000
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 51 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Chile,   Finland,   France,   Italy,   Japan,   Netherlands,   New Zealand,   Poland,   Portugal,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries Serbia
 
Administrative Information
NCT Number  ICMJE NCT00996918
Other Study ID Numbers  ICMJE 3133K1-3002
B2521003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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