Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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 May 21, 2013