A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients

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.

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Bapineuzumab 0.5 mg/kg

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: AAB-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting a Serious Adverse Event	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.	Up to Week 195

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78	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.	Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.	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.	Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.	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.	Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.	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.	Base Study Baseline, Weeks 13, 26, 39, 52 and 78
Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.	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.	Base Study Baseline, Weeks 26, 52 and 78
Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.	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.	Base Study Baseline, Weeks 26, 52 and 78
Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.	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.	Base Study Baseline, Weeks 6, 19, 32, 45 and 78
Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.	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.	Base Study Baseline, Weeks 6, 19, 32, 45 and 78

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: October 16, 2009
• First Submitted That Met QC Criteria: October 19, 2009
• First Posted (ESTIMATE): October 20, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: immunotherapy; antibody
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 3133K1-3003; B2521004 (OTHER: Alias Study Number); 2009-015080-13 (EUDRACT_NUMBER)