Study Evaluating the Safety and Efficacy 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:
NCT00676143
First received: May 2, 2008
Last updated: December 20, 2012
Last verified: December 2012
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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 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 Boundary 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: | 1099 |
| Study Start Date: | May 2008 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (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
|
| 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 AD, with MMSE score of 16-26, and brain 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, or a major psychiatric disorder
- Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)
- Woman of childbearing potential
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676143
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| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
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| Goodyear, Arizona, United States, 85395 | |
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| Phoenix, Arizona, United States, 85050 | |
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| Phoenix, Arizona, United States, 85006 | |
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| Phoenix, Arizona, United States, 85032 | |
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| Little Rock, Arkansas, United States, 72205 | |
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| Carson, California, United States, 90746 | |
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| Long Beach, California, United States, 90806 | |
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| San Francisco, California, United States, 94109 | |
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| Boulder, Colorado, United States, 80304 | |
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| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
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| Fairfield, Connecticut, United States, 06824 | |
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| Greenwich, Connecticut, United States, 06830 | |
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| New Haven, Connecticut, United States, 06520 | |
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| New Haven, Connecticut, United States, 06511 | |
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| New Haven, Connecticut, United States, 06510 | |
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| New Haven, Connecticut, United States, 06519 | |
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| Norwalk, Connecticut, United States, 06851 | |
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| Atlantis, Florida, United States, 33462 | |
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| Delray Beach, Florida, United States, 33445 | |
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| Orlando, Florida, United States, 32806 | |
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| Palm Beach Gardens, Florida, United States, 33418 | |
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| Port Charlotte, Florida, United States, 33952 | |
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| Sarasota, Florida, United States, 34243 | |
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| Tampa, Florida, United States, 33613 | |
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| Decatur, Georgia, United States, 30033 | |
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| Lawrenceville, Georgia, United States, 30045 | |
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| Elk Grove Village, Illinois, United States, 60007 | |
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| Ann Arbor, Michigan, United States, 48105-2945 | |
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| Ann Arbor, Michigan, United States, 48110 | |
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| Ann Arbor, Michigan, United States, 48109 | |
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| Ann Arbor,, Michigan, United States, 48109-5872 | |
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| Willow Grove, Pennsylvania, United States, 19090 | |
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| Providence, Rhode Island, United States, 02906 | |
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| Charleston, South Carolina, United States, 29425 | |
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| North Charleston, South Carolina, United States, 29406 | |
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| Dallas, Texas, United States, 75214 | |
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| San Antonio, Texas, United States, 78258 | |
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| San Antonio, Texas, United States, 78231 | |
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| San Antonio, Texas, United States, 78229 | |
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| Bennington, Vermont, United States, 05201 | |
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| Madison, Wisconsin, United States, 53705-2280 | |
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| Madison, Wisconsin, United States, 53792 | |
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| Madison, Wisconsin, United States, 53705 | |
| Argentina | |
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| Buenos Aires, Argentina, C1199ABD | |
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| Buenos Aires, Argentina, 1431 | |
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| Buenos Aires, Argentina, 1090 | |
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| Gosford, New South Wales, Australia, 2250 | |
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| Hornsby, New South Wales, Australia, 2077 | |
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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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| Nedlands, Western Australia, Australia, 6009 | |
| Australia | |
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| Adelaide, Australia, 5000 | |
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| Graz, Austria, 8036 | |
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| Klagenfurt, Austria, A-9020 | |
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| Wien, Austria, 1090 | |
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| Wien, Austria, 1220 | |
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| Wien, Austria, A-1220 | |
| Belgium | |
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| Antwerpen, Belgium, 2020 | |
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| Brugge, Belgium, 8000 | |
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| Brussels, Belgium, 1200 | |
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| Edegem, Belgium, 2650 | |
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| Leuven, Belgium, 3000 | |
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| Roeselare, Belgium, 8800 | |
| Chile | |
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| Santiago, Chile | |
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| Santiago, Chile, 7530193 | |
| Croatia | |
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| Zagreb, Croatia, 10000 | |
| Finland | |
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| Kuopio, Finland, FIN-70210 | |
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| Turku, Finland, 20520 | |
| France | |
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| Bordeaux Cedex, France, 33076 | |
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| Bron, France, 69677 | |
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| Caen, France, 14000 | |
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| Caen, France, 14033 | |
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| Colmar, France, 68024 | |
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| Dijon, France, 21033 | |
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| Lille, France, 59037 | |
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| Marseille, France, 13385 | |
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| Montpellier, France, 34295 | |
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| Nantes - Saint Herblain, France, 44093 | |
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| Nice, France, 06000 | |
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| Nice, France, 06002 | |
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| Paris, France, 75651 | |
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| Poitiers, France, 86000 | |
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| Reims, France, 51092 | |
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| Rennes Cedex, France, 35064 | |
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| Rouen, France, 76031 | |
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| Toulouse, France, 31059 | |
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| Toulouse, France, 31300 | |
| Germany | |
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| Berlin, Germany, 14050 | |
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| Bochum, Germany, 44791 | |
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| Dresden, Germany, 01307 | |
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| Freiburg, Germany, 79106 | |
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| Offenburg, Germany, 77654 | |
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| Ulm, Germany, 89081 | |
| Italy | |
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| Ancona, Italy, 60020 | |
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| Brescia, Italy, 25123 | |
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| Catania, Italy, 95123 | |
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| Catania, Italy, 95126 | |
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| Chieti, Italy, 66013 | |
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| Milano, Italy, 20133 | |
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| Monza, Italy, 20052 | |
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| Roma, Italy, 00128 | |
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| Roma, Italy, 00179 | |
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| Siena, Italy, 53100 | |
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| Nagoya, Aichi,, Japan | |
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| Kiyose, Tokyo, Japan | |
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| Mexico | |
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| Monterrey, Nuevo León, Mexico, 64000 | |
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| Aguascalientes, Mexico, 20127 | |
| Netherlands | |
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| Breda, Noord Brabant, Netherlands, 4818 CK | |
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| Hilversum, Noord Holland, Netherlands, 1213 XZ | |
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| 's-Hertogenbosch, Netherlands, 5223 GZ | |
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| Alkmaar, Netherlands, 1815 JD | |
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| Amsterdam, Netherlands, 1081 HV | |
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| Eindhoven, Netherlands, 5623 EJ | |
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| Leeuwarden, Netherlands, 8934 AD | |
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| Rotterdam, Netherlands, 3015 CE | |
| New Zealand | |
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| Auckland, NZ, New Zealand, 0622 | |
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| Christchurch, New Zealand, 8014 | |
| Poland | |
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| Bydgoszcz, Poland, 85-796 | |
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| Krakow, Poland, 31-531 | |
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| Poznan, Poland, 61-289 | |
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| Warszawa, Poland, 02-097 | |
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| Warszawa, Poland, 01-211 | |
| Portugal | |
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| Amadora, Portugal, 2720-276 | |
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| Coimbra, Portugal, 3000-075 | |
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| Lisboa, Portugal, 1649-028 | |
| Serbia | |
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| Belgrade, Serbia, 11000 | |
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| Kragujevac, Serbia, 34000 | |
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| Novi Sad, Serbia, 21000 | |
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| Sremska Kamenica, Serbia, 21204 | |
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| Bratislava, Slovakia, 825 56 | |
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| Bratislava, Slovakia, 820 07 | |
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| Michalovce, Slovakia, 071 01 | |
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| Rimavska Sobota, Slovakia, 979 12 | |
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| Johannesburg, Gauteng, South Africa, 1709 | |
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| Johannesburg, Gauteng, South Africa, 2196 | |
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| Pretoria, Gauteng, South Africa, 0081 | |
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| Durban, Kwa Zulu Natal, South Africa, 4001 | |
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| Bellville, Western Cape, South Africa, 7530 | |
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| Panorama, Western Cape, South Africa, 7500 | |
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| Elche, Alicante, Spain, 03203 | |
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| Terrassa, Barcelona, Spain, 08221 | |
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| Plasencia, Caceres, Spain, 10600 | |
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| San Sebastian, Pais Vasco, Spain, 20014 | |
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| Murcia, Spain, 30120 | |
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| Malmo, Sweden, 21 224 | |
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| Uppsala, Sweden, 75185 | |
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| Uppsala, Sweden, 751 09 | |
| Switzerland | |
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| Basel, BS, Switzerland, CH-4031 | |
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| Les Acacias, GE, Switzerland, 1227 | |
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| Lausanne, VD, Switzerland, 1005 | |
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| Thonex-Geneva, Switzerland, CH-1226 | |
| United Kingdom | |
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| Blackpool, Lancashire, United Kingdom, FY2 0JH | |
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| Trafford Park, Manchester, United Kingdom, M32 0UT | |
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| Bradford, United Kingdom, BD3 0DQ | |
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| Brighton, United Kingdom, BN2 5BE | |
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| Glasgow, United Kingdom, G20 0XA | |
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| London, United Kingdom, SE5 9RS | |
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| London, United Kingdom, W6 8RF | |
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| Newcastle upon Tyne, United Kingdom, NE4 5PL | |
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| Northampton, United Kingdom, NN1 5BD | |
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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: | NCT00676143 History of Changes |
| Obsolete Identifiers: | NCT00909675 |
| Other Study ID Numbers: | 3133K1-3001, B2521002 |
| Study First Received: | May 2, 2008 |
| Last Updated: | December 20, 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 19, 2013