A Long-Term Safety And Tolerability Extension Study 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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00998764
First received: October 16, 2009
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

Condition Intervention Phase
Alzheimer Disease
Drug: Bapineuzumab 0.5 mg/kg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Extension, Multicenter, Long Term Safety And Tolerability Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants Reporting a Serious Adverse Event [ Time Frame: Up to Week 195 ] [ Designated as safety issue: No ]
    Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.


Secondary Outcome Measures:
  • Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78 [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ] [ Designated as safety issue: No ]
    The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8 remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.

  • Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78. [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ] [ Designated as safety issue: No ]
    The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8)remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.

  • Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78. [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ] [ Designated as safety issue: No ]
    The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant's caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is "yes" and a zero score was assigned if the answer is "no". For questions answered as "not applicable", no score will be assigned. The DAD total score was calculated as the total number of questions answered as "yes" divided by the total number of questions answered as "yes" or "no", times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.

  • Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78. [ Time Frame: Base Study Baseline, Weeks 13, 26, 39, 52 and 78 ] [ Designated as safety issue: No ]
    The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant's caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is "yes" and a zero score was assigned if the answer is "no". For questions answered as "not applicable", no score will be assigned. The DAD total score was calculated as the total number of questions answered as "yes" divided by the total number of questions answered as "yes" or "no", times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.

  • Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78. [ Time Frame: Base Study Baseline, Weeks 26, 52 and 78 ] [ Designated as safety issue: No ]
    NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.

  • Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78. [ Time Frame: Base Study Baseline, Weeks 26, 52 and 78 ] [ Designated as safety issue: No ]
    NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.

  • Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78. [ Time Frame: Base Study Baseline, Weeks 6, 19, 32, 45 and 78 ] [ Designated as safety issue: No ]
    MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.

  • Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78. [ Time Frame: Base Study Baseline, Weeks 6, 19, 32, 45 and 78 ] [ Designated as safety issue: No ]
    MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.


Enrollment: 494
Study Start Date: December 2009
Study Completion Date: November 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 0.5 mg/kg
I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.
Other Name: AAB-001

  Eligibility

Ages Eligible for Study:   51 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has completed study 3133K1-3001 (Week 78) and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease
  • Mini-Mental Status Examination (MMSE) >=10 at screening
  • Caregiver able to attend all clinic visits with subject

Exclusion Criteria:

  • Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
  • Any significant brain MRI abnormality.
  • Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998764

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
UAB Center for Psychiatric Medicine
Birmingham, Alabama, United States, 35294
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Dedicated Clinical Research
Goodyear, Arizona, United States, 85395
Hope Research Institute
Phoenix, Arizona, United States, 85050
Banner Good Samaritan Medical Center (Imaging
Phoenix, Arizona, United States, 85006
Jeffrey S. Gitt
Phoenix, Arizona, United States, 85032
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
United States, Arkansas
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
United States, California
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
United States, Colorado
Associated Neurologist, PC
Boulder, Colorado, United States, 80304
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States, 80304
Mile High Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, United States, 06824
Center for Healthy Aging, Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Bendheim Infusion Center, Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States, 06851
United States, Florida
JEM Research LLC
Atlantis, Florida, United States, 33462
Medical Specialists of the Palm Beaches
Atlantis, Florida, United States, 33462
Brain Matters Research
Delray Beach, Florida, United States, 33445
Compass Research, LLC
Orlando, Florida, United States, 32806
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States, 33418
Southwest Florida Infusion Care, Inc.
Port Charlotte, Florida, United States, 33952
Neurostudies, Inc
Port Charlotte, Florida, United States, 33952
Roskamp Institute
Sarasota, Florida, United States, 34234
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States, 33613
United States, Georgia
Neuroscience Research Institute, LLC
Lawrenceville, Georgia, United States, 30046
Neurostudies.net
Lawrenceville, Georgia, United States, 30046
United States, Illinois
Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, United States, 60007
Southern Illinois University School of Medicine Department
Springfield, Illinois, United States, 62702
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
United States, Massachusetts
Neuroscience Research of the Berkshires
Pittsfield, Massachusetts, United States, 01201
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States, 01104
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Michigan State University
East Lansing, Michigan, United States, 48848
United States, Mississippi
Neurological Research Center of Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States, 64114
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Alzheimer's Research Corp./Merician Institute for Aging
Manchester, New Jersey, United States, 08759
Toms River X-Ray, CT & MRI
Toms River, New Jersey, United States, 08755
United States, New York
MDR
LiverPool, New York, United States, 13088
Neurological Care of Central New York
Liverpool, New York, United States, 13088
United States, North Carolina
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
Healthsouth Blue Ridge Surgery Center
Raleigh, North Carolina, United States, 27607
Carolina Neuropsychological Services, Inc.
Raleigh, North Carolina, United States, 27607
Wake Radiology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Ohio State Unviersity
Columbus, Ohio, United States, 43210
United States, Oregon
Summit Research Network(Oregon) Inc.
Portland, Oregon, United States, 97210
Providence Brain Institute-Cognitive Assessment Clinic
Portland, Oregon, United States, 97225
Providence Brain Institute
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Neurological Associates
Abington, Pennsylvania, United States, 19001
Abington Neurological Assoc
Abington, Pennsylvania, United States, 19001
Bington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Medical University of South Carolina Hospitals and Clinics
Charleston, South Carolina, United States, 29245
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Texas
Texas Neurology, P.A.
Dallas, Texas, United States, 75214
Vista Infusions
San Antonio, Texas, United States, 78231
Integra Clinical Research, LLC
San Antonio, Texas, United States, 78231
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
Inventive Infusion Solutions
San Antonio, Texas, United States, 78258
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
Australia, New South Wales
Gosford Hospital; Pharmacy Dept
Gosford, New South Wales, Australia, 2250
Hornsby Hospital
Hornsby, New South Wales, Australia, 2207
Australia, South Australia
Royal Adelaide Memory Trials Centre
Adelaide, South Australia, Australia, 5000
Memory Unit 5C, Department of Neurology
Woodville South, South Australia, Australia, 5011
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Heidelberg Repatriation Hospital
Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
Hollywood Hospital; Pharmacy Dept
Nedlands, Western Australia, Australia, 6009
The McCusker Foundation for Alzheimer's Disease Research
Nedlands, Western Australia, Australia, 6009
Belgium
ZNA Middelheim
Antwerpen, Belgium, 2020
AZ Sint-Jan Brugge-Oostende AV
Brugge, Belgium, 8000
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
H.-Hartziekenhuis Roeselare-Menen
Roeselare, Belgium, 8800
Chile
Psicomedica Research Group
Santiago, Chile, 7530193
Finland
Ita-Suomen Yliopisto
Kuopio, Finland, FIN-70210
University of Turku/CRST
Turku, Finland, FIN-20520
France
CHU Hôpital Pellegrin-Tripode
Bordeaux, France, 33076
Hopital Neurologique
Bron, France, 69677
CHU de Caen
Caen, France, 14033
Hôpitaux Civils de Colmar
Colmar, France, 68024
CHU de Dijon
Dijon, France, 21000
Hôpital Roger Salengro
Lille, France, 59037
Hôpital la Timone
Marseille, France, 13885
Hôpital la Timone
Marseille cedex 5, France, 13385
CHU Hôpital Gui de Chaulliac
Montpellier, France, 34295
CHU Nord - Hôpital Guillaume et René Laënnec
Nantes - Saint Herblain, France, 44093
Hôpital Cimiez
Nice, France, 06000
Hôpital Pitié-Salpétrière
Paris, France, 75013
CHU La Milétrie
Poitiers, France, 86021
C.H.U de Reims
Reims, France, 51000
CHRU Hôtel Dieu
Rennes, France, 35064
Department de Radiologie et d'Imagerie Medicale, Hopital Pontchaillou
Rennes Cedex 9, France, 35033
Centre Hospitalier Universitaire Charles Nicolle
Rouen Cedex, France, 76031
CHU Purpan - Hôpital Casselardit
Toulouse, France, 31300
Hôpital Purpan
Toulouse, France, 31059
Italy
Sezione di Neurologia - Dipartimento di Neuroscienze
Ancona, Italy, 60020
Dipartimento di Neuroscienze,
Catania, Italy, 95123
Fondazione IRCCS- Istituto Neurologico Carlo Besta
Milano, Italy, 20133
Unita' Operativa C - Riabilitazione Neurologica
Roma, Italy, 00179
Japan
Nagoya City University Hospital
Nagoya, Aichi,, Japan, 467-8602
Yachiyo Hospital
Aichi, Japan, 446-8510
Nippon Medical School Chiba Hokusoh Hospital
Chiba, Japan, 270-1694
Kashiwado Hospital
Chiba, Japan, 260-8656
National Hospital Organization Chiba-East Hospital
Chiba-shi, Japan, 260-8712
National Hospital Organization Kokura Medical Center
Fukuoka, Japan, 802-8533
Maebashi Red Cross Hospital
Gunma, Japan, 371-0014
Gunma University Hospital
Gunma, Japan, 371-8511
Shinozuka Hospital
Gunma, Japan, 375-0017
National Hospital Organization Hiroshima-nishi Medical Ctr.
Hiroshima, Japan, 739-0696
Kobe University Hospital
Hyogo, Japan, 650-0017
Kagawa University Hospital
Kagawa, Japan, 761-0793
Nippon Medical School Musashi Kosugi Hospital
Kanagawa, Japan, 211-8533
Rakuwakai Otowa Hospital
Kyoto, Japan, 607-8062
National Hospital Organization Minami-Kyoto Hospital
Kyoto, Japan, 610-0113
National Hospital Organization Maizuru Medical Center
Kyoto, Japan, 625-8502
National Hospital Organization Matsumoto Medical Center
Nagano, Japan, 399-0021
National Hospital Organization Niigata National Hospital
Niigata, Japan, 945-8585
Okayama University Hospital
Okayama, Japan, 700-8558
National Hospital Organization Minami-Okayama Medical Center
Okayama, Japan, 701-0304
Osaka City University Hospital
Osaka, Japan, 545-8586
Kansai Medical University Takii Hospital
Osaka, Japan, 570-8507
Juntendo University Hospital
Tokyo, Japan, 113-8431
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, Japan, 136-0075
Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp
Tokyo, Japan, 145-0065
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Tokyo Medical University Hachioji Medical Center
Tokyo, Japan, 193-0944
National Hospital Organization Tokyo National Hospital
Tokyo, Japan, 204-8585
Netherlands
Geriatry
's-HERTOGENBOSCH, Netherlands, 5223 GZ
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5223 GZ
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
New Zealand
The Memory Clinic Limited
Auckland, New Zealand, 0622
Christchurch Hospital
Christchurch, New Zealand, 8011
Signet Research
Christchurch, New Zealand, 8014
Poland
Pallmed Spolka z o.o.
Bydgoszcz, Poland, 85-796
MCD Voxel
Poznan, Poland, 60-693
NZOZ Neuro-kard
Poznan, Poland, 61-289
Pracownia Rezonansu Magnetycznego
Warszawa, Poland, 01-211
SP ZOZ Szpital Wolski
Warszawa, Poland, 01-211
Samodzielny Publiczny Centralny Szpital Kliniczny
Warszawa, Poland, 02-097
Portugal
Hospital Fernando da Fonseca
Amadora, Lisboa, Portugal, 2720-276
Hospitais Da Universidade De Coimbra
Coimbra, Portugal, 3000-075
Hospital Santa Maria
Lisboa, Portugal, 1649-028
Slovakia
Univerzitna nemocnica Bratislava
Bratislava, Slovakia, 825 56
Vseobecna nemocnica Rimavska Sobota
Rimavska Sobota, Slovakia, 979 12
South Africa
Boithuso Caregivers
Johannesburg, Gauteng, South Africa, 1709
The Osteoporosis and Memory Centre
Johannesburg, Gauteng, South Africa, 2196
St Augustine's Medical Centre 2
Durban, Kwa Zulu Natal, South Africa, 4001
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Hospital Mutua de Terrasa
Terrasa, Barcelona, Spain, 08221
Hospital Virgen del Puerto
Plasencia, Caceres, Spain, 10600
Hospital Universitario Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07010
CLONUS
Palma de Mallorca, Islas Baleares, Spain, 07014
Hospital del Mar
Barcelona, Spain, 08003
Fundacio ACE Institut Catala de Neurociences Aplicades
Barcelona, Spain, 08014
Clinica CIMA
Barcelona, Spain, 08034
Hospital Divino Valles
Burgos, Spain, 09006
Hospital de la Princesa
Madrid, Spain, 28006
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Sweden
Malmo University Hospital
Malmo, Sweden, 21 224
Minnes- och geriatrikmottagningen
Uppsala, Sweden, 75185
Switzerland
Memory Clinic Neuro-Psychologie Zentrum
Basel, BS, Switzerland, CH-4031
United Kingdom
Memory Service North, Grenoside Grange Hospital
Grenoside, Sheffield, United Kingdom, S35 8QS
Llandough Hospital, Universtity Hospital of Wales
Cardiff, Wales, United Kingdom, CF4 4XW
MAC UK Neuroscience Ltd.
Bradford, United Kingdom, BDQ0DQ
Clinical Investigation and Research Unit (CIRU)
Brighton, United Kingdom, BN2 5BE
Glasgow Memory Clinic
Glasgow, United Kingdom, G20 OXA
The Doctors Laboratory Ltd.
London, United Kingdom, WIT 4EU
Dept. of Neurosciences Charing Cross Hospital
London, United Kingdom, W6 8RF
Newcastle General Hospital
Newcastle upon Tyne, United Kingdom, NE4 5PL
Northampton General Hospital
Northampton, United Kingdom, NN1 5BD
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Victoria Hospital
Swindon, United Kingdom, SN3 6BW
Alliance Medical
Wakefield, United Kingdom, WF1 4TT
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00998764     History of Changes
Other Study ID Numbers: 3133K1-3003  B2521004  2009-015080-13 
Study First Received: October 16, 2009
Results First Received: October 15, 2013
Last Updated: November 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
antibody
immunotherapy

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

ClinicalTrials.gov processed this record on May 04, 2016