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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00397891
First received: November 8, 2006
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
Drug: bapineuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety and tolerability of single ascending doses of AAB-001 in Japanese subjects with mild to moderate AD. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetic (PK) profile of single doses of AAB-001 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
bapineuzumab 0.15 mg/kg or placebo
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: 2
bapineuzumab 0.5 mg/kg or placebo
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: 3
bapineuzumab 1.0 mg/kg or placebo
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397891

Locations
Japan
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Saitama, Japan
Pfizer Investigational Site
Shizuoka, Japan
Pfizer Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00397891     History of Changes
Other Study ID Numbers: 3133K1-102
Study First Received: November 8, 2006
Last Updated: March 28, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014