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Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
University of Alabama-Birmingham
Birmingham, Alabama, 35294 United States
Contact
1-800-718-1021
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
50-89 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination
(MMSE) score of 16-26, and brain magnetic resonance imaging (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

- Major psychiatric disorder

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

- Women of childbearing potential

NCT00667810
Pfizer
Terminated
Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

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Descriptive Information
Brief Title  ICMJE Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
Official Title  ICMJE A Phase 3, 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 Non-carriers
Brief SummaryThis 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 DescriptionNot 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: bapineuzumab
    Bapineuzumab 1.0 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
  • Experimental: Bapineuzumab 1.0 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: December 4, 2015)
901
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2008)
1250
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion DateOctober 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (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
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body]
  • Women of childbearing potential
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 89 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,   Belgium,   Canada,   Chile,   Croatia,   Finland,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location CountriesAustria,   Czech Republic,   Denmark,   Former Serbia and Montenegro,   Ireland
 
Administrative Information
NCT Number  ICMJE NCT00667810
Other Study ID Numbers  ICMJE 3133K1-3000
B2521001 ( Other Identifier: Alias Study Number )
2007-005994-79 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2015

ICMJE     Data element required by the

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

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

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1-800-718-1021

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