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Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85006 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.
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- Diagnosis of probable Alzheimer Disease according to National Institute of
Neurological and Communicative Disorders and Stroke/Alzheimer`s Disease and Related
Disorders Association (NINCDS/ADRDA) criteria

- Mini-Mental State Examination (MMSE) score 16-26

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

- Magnetic Resonance Imaging (MRI) showing other brain abnormalities

- Other diagnosed neurological or psychiatric disorders

NCT00663026
Pfizer
Completed
Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

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Descriptive Information
Brief Title  ICMJE Study Evaluating Bapineuzumab In Alzheimer Disease Subjects
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Safety, Tolerability, Reactogenicity, And Pharmacokinetic Study Of Bapineuzumab (AAB 001) Administered Subcutaneously In Subjects With Mild To Moderate AD
Brief SummaryThe study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate Alzheimer disease. Subjects will be in the study for six months and will receive subcutaneous injections once per week.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: bapineuzumab
    5 mg bapineuzumab subcutaneous injection once per week for 6 months
  • Drug: bapineuzumab
    10 mg bapineuzumab subcutaneous injection once per week for 6 months
  • Drug: placebo
    Placebo subcutaneous injection once per week for 6 months
Study Arms  ICMJE
  • Experimental: A
    5 mg/week
    Intervention: Drug: bapineuzumab
  • Experimental: B
    10 mg/week
    Intervention: Drug: bapineuzumab
  • Experimental: C
    Placebo
    Intervention: Drug: placebo
Publications *Not Provided


*   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 Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2013)
79
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2008)
120
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion DateOctober 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable Alzheimer Disease according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer`s Disease and Related Disorders Association (NINCDS/ADRDA) criteria
  • Mini-Mental State Examination (MMSE) score 16-26

Exclusion Criteria:

  • Magnetic Resonance Imaging (MRI) showing other brain abnormalities
  • Other diagnosed neurological or psychiatric disorders
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00663026
Other Study ID Numbers  ICMJE 3133L1-2203
B2521008
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 DateSeptember 2013

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 the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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