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Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab

Last updated on November 7, 2019

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Study Location
Banner Alzheimer's Institute
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
50-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of probable Alzheimer disease

- Completed preceding double-blind study (3133L1-2203 US)

- MMSE score > 9.

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

- Significant brain MRI abnormalities

- Clinically important psychiatric symptoms

- History of stroke

NCT00916617
Pfizer
Terminated
Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab

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Descriptive Information
Brief Title  ICMJE Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
Official Title  ICMJE A Multicenter, Open Label, Multiple Dose, Parallel Group Investigation Of The Long-term Safety, Tolerability, Reactogenicity, Pharmacokinetics And Pharmacodynamics Of Aab-001 Administered Subcutaneously In Subjects With Mild To Moderate Alzheimer's Disease
Brief SummaryThis study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Drug: bapineuzumab
5 mg/week subcutaneous bapineuzumab
Study Arms  ICMJE Experimental: 1
5 mg/week
Intervention: Drug: bapineuzumab
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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 27, 2017)
62
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2009)
120
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion DateSeptember 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable Alzheimer disease
  • Completed preceding double-blind study (3133L1-2203 US)
  • MMSE score > 9.

Exclusion Criteria:

  • Significant brain MRI abnormalities
  • Clinically important psychiatric symptoms
  • History of stroke
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 NCT00916617
Other Study ID Numbers  ICMJE 3133L1-2204
B2521009 ( Other Identifier: Alias Study 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 JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2017

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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