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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Center for Psychiatric Medicine
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
50-88 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

NCT00676143
Pfizer
Terminated
Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

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Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • 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.
  • Experimental: Bapineuzumab 0.5 mg/kg
    Intervention: Drug: bapineuzumab
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1100
November 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 88 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Czech Republic,   Denmark,   Ireland,   Jamaica
 
NCT00676143
3133K1-3001
B2521002 ( Other Identifier: Alias Study Number )
2007-005995-14 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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