Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
This study has been terminated.
(The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00667810
First received: April 24, 2008
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: bapineuzumab Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy And Safety Trial Of Bapineuzumab In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E ε4 Non-Carriers |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Alzheimer's Disease Assessment Scale-Cognitive Subscale total score [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
- Disability Assessment for Dementia total score [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Brain Amyloid Burden [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
- CSF Phospho-tau level [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
- MRI Brain Boundry Shift Integral [ Time Frame: 71 Weeks ] [ Designated as safety issue: No ]
- Divergence of effect [ Time Frame: 39 Weeks ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
- Dependence Scale [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
- Proportion of Responders [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
- Clinical Dementia Rating Sum of Boxes [ Time Frame: 78 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 835 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bapineuzumab 0.5 mg/kg |
Drug: bapineuzumab
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Other Name: AAB-001
|
| Experimental: Bapineuzumab 1.0 mg/kg |
Drug: bapineuzumab
Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Other Name: AAB-001
|
| Placebo Comparator: Placebo |
Drug: placebo
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
|
Eligibility| Ages Eligible for Study: | 50 Years to 88 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD
- Concurrent use of cholinesterase inhibitor or memantine allowed, if stable
- Caregiver will participate and be able to attend clinic visits with patient
Exclusion Criteria:
- Significant neurological disease other than AD
- Major psychiatric disorder
- Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body]
- Women of childbearing potential
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667810
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| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
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| Goodyear, Arizona, United States, 85395 | |
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| Phoenix, Arizona, United States, 85032 | |
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| Little Rock, Arkansas, United States, 72205 | |
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| Costa Mesa, California, United States, 92626 | |
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| Fresno, California, United States, 93720 | |
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| Loma Linda, California, United States, 92354 | |
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| San Diego, California, United States, 92103 | |
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| San Francisco, California, United States, 94109 | |
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| Boulder, Colorado, United States, 80304 | |
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| Buenos Aires, Argentina, 1431 | |
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| Buenos Aires, Argentina, C1181ACH | |
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| Gosford, New South Wales, Australia, 2250 | |
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| Hornsby, New South Wales, Australia, 02077 | |
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| Woodville South, South Australia, Australia, 5011 | |
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| Ballarat, Victoria, Australia, 3353 | |
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| West Heidelberg, Victoria, Australia, 3081 | |
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| Adelaide SA, Australia, 5000 | |
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| Nedlands, Australia, 6009 | |
| Belgium | |
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| Antwerpen, Belgium, 2020 | |
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| Brugge, Belgium, 8000 | |
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| Edegem, Belgium, 2650 | |
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| Leuven, Belgium, 3000 | |
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| Roeselare, Belgium, 8800 | |
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| North York, Ontario, Canada, M6M 3Z5 | |
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| Ottawa, Ontario, Canada, K1N 5C8 | |
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| Quebec, Canada, G3K 2P8 | |
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| Santiago, Chile, 7530193 | |
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| Zagreb, Croatia, 10000 | |
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| Kuopio, Finland, FIN-70210 | |
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| Turku, Finland, 20520 | |
| Former Serbia and Montenegro | |
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| Belgrade, Former Serbia and Montenegro, 11000 | |
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| Kragujevac, Former Serbia and Montenegro, 34000 | |
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| Rennes, Cedex, France, 35064 | |
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| Nantes - Saint Herblain, France, 44093 | |
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| Toulouse, France, 31300 | |
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| Berlin, Germany, 14050 | |
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| Offenburg, Germany, 77654 | |
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| Ancona, Italy, 60020 | |
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| Lisboa, Portugal, 1649-028 | |
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| Uppsala, Sweden, 751 85 | |
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| London, United Kingdom, W6 8RF | |
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| Penarth, United Kingdom, CF64 2XX | |
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| Sheffield, United Kingdom, S35 8QS | |
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| Sheffield, United Kingdom, S10 2JF | |
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| Swindon, United Kingdom, SN3 6BW | |
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: | NCT00667810 History of Changes |
| Obsolete Identifiers: | NCT00909623 |
| Other Study ID Numbers: | 3133K1-3000, B2521001 |
| Study First Received: | April 24, 2008 |
| Last Updated: | January 8, 2013 |
| 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 19, 2013