Study Evaluating Bapineuzumab In Alzheimer Disease Subjects
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00663026
First received: April 17, 2008
Last updated: March 27, 2012
Last verified: March 2012
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Purpose
The 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: bapineuzumab Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
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 Pfizer:
Primary Outcome Measures:
- Incidence of treatment emergent adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic parameters including serum concentration of bapineuzumab, terminal half-life of elimination, observable area under the concentration-time curve(AUC), steady state serum concentration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | November 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
5 mg/week
|
Drug: bapineuzumab
5 mg bapineuzumab subcutaneous injection once per week for 6 months
|
|
Experimental: B
10 mg/week
|
Drug: bapineuzumab
10 mg bapineuzumab subcutaneous injection once per week for 6 months
|
|
Experimental: C
Placebo
|
Drug: placebo
Placebo subcutaneous injection once per week for 6 months
|
Eligibility| Ages Eligible for Study: | 50 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663026
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85006 | |
| Pfizer Investigational Site | |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| Pfizer Investigational Site | |
| Encino, California, United States, 91316 | |
| Pfizer Investigational Site | |
| Los Alamitos, California, United States, 90720 | |
| Pfizer Investigational Site | |
| Newport Beach, California, United States, 92660 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Delray Beach, Florida, United States, 33445 | |
| Pfizer Investigational Site | |
| Hallandale, Florida, United States, 33009 | |
| Pfizer Investigational Site | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Decatur, Georgia, United States, 30033 | |
| Pfizer Investigational Site | |
| Lawrenceville, Georgia, United States, 30045 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67211 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14620 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | |
| East Providence, Rhode Island, United States, 02914 | |
| Pfizer Investigational Site | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75214 | |
| United States, Vermont | |
| Pfizer Investigational Site | |
| Bennington, Vermont, United States, 05201 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Madison, Wisconsin, United States, 53705 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00663026 History of Changes |
| Other Study ID Numbers: | 3133L1-2203, B2521008 |
| Study First Received: | April 17, 2008 |
| Last Updated: | March 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
antibody immunotherapy |
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 16, 2013