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Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chiba, , Japan
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
50-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of AD

- Age 50-85

- MMSE 14-26

- Other Inclusion Criteria Apply

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

- Significant Neurological Disease

- Major Psychiatric Disorder

- Clinically Significant Systemic Illness

- Other Exclusion Criteria Apply

NCT00397891
Pfizer
Completed
Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease

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[email protected]

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Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease
A Multicenter, Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, and Pharmakokinetic Study of Single Ascending Doses of AAB-001 in Japanese Patients With Mild to Moderate Alzheimer's Disease
Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Alzheimer Disease
Drug: bapineuzumab
The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
  • Experimental: 1
    bapineuzumab 0.15 mg/kg or placebo
    Intervention: Drug: bapineuzumab
  • Experimental: 2
    bapineuzumab 0.5 mg/kg or placebo
    Intervention: Drug: bapineuzumab
  • Experimental: 3
    bapineuzumab 1.0 mg/kg or placebo
    Intervention: Drug: bapineuzumab
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of AD
  • Age 50-85
  • MMSE 14-26
  • Other Inclusion Criteria Apply

Exclusion Criteria:

  • Significant Neurological Disease
  • Major Psychiatric Disorder
  • Clinically Significant Systemic Illness
  • Other Exclusion Criteria Apply
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00397891
3133K1-102
Yes
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2014

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

Contact

[email protected]



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