Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

NCT00676143

Last updated date
Study Location
Center for Psychiatric Medicine
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[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
50-88 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of probable AD, with MMSE score of 16-26, and brain 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.

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


- Significant neurological disease other than AD, or a major psychiatric disorder


- Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal
objects in the body)


- Woman of childbearing potential

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
Official Title  ICMJE A Phase Iii, 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 Carriers
Brief Summary This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 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
    Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
    Other Name: AAB-001
  • Drug: placebo
    Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
Study Arms  ICMJE
  • Experimental: Bapineuzumab 0.5 mg/kg
    Intervention: Drug: bapineuzumab
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications *

*   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: May 3, 2016)
1100
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2008)
800
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable AD, with MMSE score of 16-26, and brain 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.

Exclusion Criteria:

  • Significant neurological disease other than AD, or a major psychiatric disorder
  • Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
  • Woman of childbearing potential
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 88 Years   (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 Argentina,   Australia,   Austria,   Belgium,   Chile,   Croatia,   Finland,   France,   Germany,   Italy,   Japan,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Denmark,   Ireland,   Jamaica
 
Administrative Information
NCT Number  ICMJE NCT00676143
Other Study ID Numbers  ICMJE 3133K1-3001
B2521002 ( Other Identifier: Alias Study Number )
2007-005995-14 ( EudraCT Number )
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 CenterPfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP