A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
- Registration Number
- NCT00998764
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 494
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bapineuzumab 0.5 mg/kg Bapineuzumab 0.5 mg/kg -
- Primary Outcome Measures
Name Time Method Number of Participants Reporting a Serious Adverse Event Up to Week 195 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
Name Time Method Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78 Base Study Baseline, 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.
Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78. Base Study Baseline, 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.
Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78. Base Study Baseline, 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.
Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78. Base Study Baseline, 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.
Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78. Base Study Baseline, 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.
Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78. Base Study Baseline, 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.
Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78. Base Study Baseline, 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.
Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78. Base Study Baseline, 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.
Trial Locations
- Locations (180)
Research Center for Clinical Studies, Inc.
🇺🇸Norwalk, Connecticut, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Llandough Hospital, Universtity Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Hospital Santa Maria
🇵🇹Lisboa, Portugal
University of Turku/CRST
🇫🇮Turku, Finland
Carolina Neuropsychological Services, Inc.
🇺🇸Raleigh, North Carolina, United States
Toms River X-Ray, CT & MRI
🇺🇸Toms River, New Jersey, United States
Rhode Island Mood and Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Abington Neurological Associates
🇺🇸Abington, Pennsylvania, United States
Healthsouth Blue Ridge Surgery Center
🇺🇸Raleigh, North Carolina, United States
Medical University of South Carolina
🇺🇸North Charleston, South Carolina, United States
Bington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Abington Neurological Assoc
🇺🇸Abington, Pennsylvania, United States
The Center for Pharmaceutical Research, P.C.
🇺🇸Kansas City, Missouri, United States
Alzheimer's Research Corp./Merician Institute for Aging
🇺🇸Manchester, New Jersey, United States
Wake Radiology Associates
🇺🇸Raleigh, North Carolina, United States
Texas Neurology, P.A.
🇺🇸Dallas, Texas, United States
Medical University of South Carolina Hospitals and Clinics
🇺🇸Charleston, South Carolina, United States
Hollywood Hospital; Pharmacy Dept
🇦🇺Nedlands, Western Australia, Australia
Psicomedica Research Group
🇨🇱Santiago, Chile
Cliniques Universitaires St Luc
🇧🇪Brussels, Belgium
Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Neurological Research Center of Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Memory Enhancement Center of America, Inc.
🇺🇸Eatontown, New Jersey, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
MDR
🇺🇸LiverPool, New York, United States
Neurological Care of Central New York
🇺🇸Liverpool, New York, United States
Ita-Suomen Yliopisto
🇫🇮Kuopio, Finland
CHU Hôpital Gui de Chaulliac
🇫🇷Montpellier, France
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Centre Hospitalier Universitaire Charles Nicolle
🇫🇷Rouen Cedex, France
Dipartimento di Neuroscienze,
🇮🇹Catania, Italy
Yachiyo Hospital
🇯🇵Aichi, Japan
CHRU Hôtel Dieu
🇫🇷Rennes, France
Shinozuka Hospital
🇯🇵Gunma, Japan
Hôpital Roger Salengro
🇫🇷Lille, France
Nippon Medical School Chiba Hokusoh Hospital
🇯🇵Chiba, Japan
National Hospital Organization Kokura Medical Center
🇯🇵Fukuoka, Japan
Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp
🇯🇵Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Tokyo, Japan
Hôpital la Timone
🇫🇷Marseille, France
Kashiwado Hospital
🇯🇵Chiba, Japan
Osaka City University Hospital
🇯🇵Osaka, Japan
The Memory Clinic Limited
🇳🇿Auckland, New Zealand
CHU La Milétrie
🇫🇷Poitiers, France
CHU Nord - Hôpital Guillaume et René Laënnec
🇫🇷Nantes - Saint Herblain, France
Nippon Medical School Musashi Kosugi Hospital
🇯🇵Kanagawa, Japan
CHU Purpan - Hôpital Casselardit
🇫🇷Toulouse, France
MCD Voxel
🇵🇱Poznan, Poland
Pracownia Rezonansu Magnetycznego
🇵🇱Warszawa, Poland
Hopital Neurologique
🇫🇷Bron, France
Juntendo University Hospital
🇯🇵Tokyo, Japan
Juntendo Tokyo Koto Geriatric Medical Center
🇯🇵Tokyo, Japan
National Hospital Organization Hiroshima-nishi Medical Ctr.
🇯🇵Hiroshima, Japan
Clinica CIMA
🇪🇸Barcelona, Spain
Malmo University Hospital
🇸🇪Malmo, Sweden
Sezione di Neurologia - Dipartimento di Neuroscienze
🇮🇹Ancona, Italy
Alliance Medical
🇬🇧Wakefield, United Kingdom
Hôpital Cimiez
🇫🇷Nice, France
National Hospital Organization Tokyo National Hospital
🇯🇵Tokyo, Japan
Signet Research
🇳🇿Christchurch, New Zealand
CHU de Dijon
🇫🇷Dijon, France
Hospitais Da Universidade De Coimbra
🇵🇹Coimbra, Portugal
National Hospital Organization Chiba-East Hospital
🇯🇵Chiba-shi, Japan
Gunma University Hospital
🇯🇵Gunma, Japan
Kobe University Hospital
🇯🇵Hyogo, Japan
Fondazione IRCCS- Istituto Neurologico Carlo Besta
🇮🇹Milano, Italy
CHU de Caen
🇫🇷Caen, France
Department de Radiologie et d'Imagerie Medicale, Hopital Pontchaillou
🇫🇷Rennes Cedex 9, France
Dept. of Neurosciences Charing Cross Hospital
🇬🇧London, United Kingdom
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
NZOZ Neuro-kard
🇵🇱Poznan, Poland
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Minnes- och geriatrikmottagningen
🇸🇪Uppsala, Sweden
Kansai Medical University Takii Hospital
🇯🇵Osaka, Japan
Glasgow Memory Clinic
🇬🇧Glasgow, United Kingdom
Maebashi Red Cross Hospital
🇯🇵Gunma, Japan
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Clinical Investigation and Research Unit (CIRU)
🇬🇧Brighton, United Kingdom
Boithuso Caregivers
🇿🇦Johannesburg, Gauteng, South Africa
Hospital Fernando da Fonseca
🇵🇹Amadora, Lisboa, Portugal
Hospital Mutua de Terrasa
🇪🇸Terrasa, Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Hospital de la Princesa
🇪🇸Madrid, Spain
Univerzitna nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Hospital Divino Valles
🇪🇸Burgos, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
MAC UK Neuroscience Ltd.
🇬🇧Bradford, United Kingdom
Northampton General Hospital
🇬🇧Northampton, United Kingdom
Victoria Hospital
🇬🇧Swindon, United Kingdom
The Doctors Laboratory Ltd.
🇬🇧London, United Kingdom
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
University Of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
UAB Center for Psychiatric Medicine
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Banner Good Samaritan Medical Center (Imaging
🇺🇸Phoenix, Arizona, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
Ohio State Unviersity
🇺🇸Columbus, Ohio, United States
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
Vista Infusions
🇺🇸San Antonio, Texas, United States
Inventive Infusion Solutions
🇺🇸San Antonio, Texas, United States
Newcastle General Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Summit Research Network(Oregon) Inc.
🇺🇸Portland, Oregon, United States
Providence Brain Institute-Cognitive Assessment Clinic
🇺🇸Portland, Oregon, United States
Providence Brain Institute
🇺🇸Portland, Oregon, United States
Hôpital Purpan
🇫🇷Toulouse, France
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
🇺🇸Palm Beach Gardens, Florida, United States
Heidelberg Repatriation Hospital
🇦🇺Heidelberg West, Victoria, Australia
Unita' Operativa C - Riabilitazione Neurologica
🇮🇹Roma, Italy
Integra Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Gosford Hospital; Pharmacy Dept
🇦🇺Gosford, New South Wales, Australia
Royal Adelaide Memory Trials Centre
🇦🇺Adelaide, South Australia, Australia
Dedicated Clinical Research
🇺🇸Goodyear, Arizona, United States
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
Jeffrey S. Gitt
🇺🇸Phoenix, Arizona, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Alpine Clinical Research Center, Inc.
🇺🇸Boulder, Colorado, United States
Associated Neurologist, PC
🇺🇸Boulder, Colorado, United States
Associated Neurologists of Southern Connecticut, P.C.
🇺🇸Fairfield, Connecticut, United States
Bendheim Infusion Center, Greenwich Hospital
🇺🇸Greenwich, Connecticut, United States
Center for Healthy Aging, Greenwich Hospital
🇺🇸Greenwich, Connecticut, United States
Medical Specialists of the Palm Beaches
🇺🇸Atlantis, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Neurostudies, Inc
🇺🇸Port Charlotte, Florida, United States
Southwest Florida Infusion Care, Inc.
🇺🇸Port Charlotte, Florida, United States
Roskamp Institute
🇺🇸Sarasota, Florida, United States
Neuroscience Research Institute, LLC
🇺🇸Lawrenceville, Georgia, United States
Alexian Brothers Neurosciences Institute Clinical Research
🇺🇸Elk Grove Village, Illinois, United States
Neurostudies.net
🇺🇸Lawrenceville, Georgia, United States
Southern Illinois University School of Medicine Department
🇺🇸Springfield, Illinois, United States
USF Health Byrd Alzheimer's Institute
🇺🇸Tampa, Florida, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
Springfield Neurology Associates, LLC
🇺🇸Springfield, Massachusetts, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Hornsby Hospital
🇦🇺Hornsby, New South Wales, Australia
Memory Unit 5C, Department of Neurology
🇦🇺Woodville South, South Australia, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
ZNA Middelheim
🇧🇪Antwerpen, Belgium
Universitair Ziekenhuis Gasthuisberg
🇧🇪Leuven, Belgium
CHU Hôpital Pellegrin-Tripode
🇫🇷Bordeaux, France
Hôpital Pitié-Salpétrière
🇫🇷Paris, France
Hôpitaux Civils de Colmar
🇫🇷Colmar, France
C.H.U de Reims
🇫🇷Reims, France
National Hospital Organization Niigata National Hospital
🇯🇵Niigata, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi,, Japan
Kagawa University Hospital
🇯🇵Kagawa, Japan
National Hospital Organization Minami-Kyoto Hospital
🇯🇵Kyoto, Japan
Rakuwakai Otowa Hospital
🇯🇵Kyoto, Japan
National Hospital Organization Maizuru Medical Center
🇯🇵Kyoto, Japan
National Hospital Organization Matsumoto Medical Center
🇯🇵Nagano, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
National Hospital Organization Minami-Okayama Medical Center
🇯🇵Okayama, Japan
Geriatry
🇳🇱's-HERTOGENBOSCH, Netherlands
Tokyo Medical University Hospital
🇯🇵Tokyo, Japan
The Osteoporosis and Memory Centre
🇿🇦Johannesburg, Gauteng, South Africa
St Augustine's Medical Centre 2
🇿🇦Durban, Kwa Zulu Natal, South Africa
Memory Service North, Grenoside Grange Hospital
🇬🇧Grenoside, Sheffield, United Kingdom
Hospital Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Neuroscience Research of the Berkshires
🇺🇸Pittsfield, Massachusetts, United States
Samodzielny Publiczny Centralny Szpital Kliniczny
🇵🇱Warszawa, Poland
Vseobecna nemocnica Rimavska Sobota
🇸🇰Rimavska Sobota, Slovakia
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Islas Baleares, Spain
Pallmed Spolka z o.o.
🇵🇱Bydgoszcz, Poland
SP ZOZ Szpital Wolski
🇵🇱Warszawa, Poland
Memory Clinic Neuro-Psychologie Zentrum
🇨ðŸ‡Basel, BS, Switzerland
CLONUS
🇪🇸Palma de Mallorca, Islas Baleares, Spain
JEM Research LLC
🇺🇸Atlantis, Florida, United States
AZ Sint-Jan Brugge-Oostende AV
🇧🇪Brugge, Belgium
H.-Hartziekenhuis Roeselare-Menen
🇧🇪Roeselare, Belgium
The McCusker Foundation for Alzheimer's Disease Research
🇦🇺Nedlands, Western Australia, Australia
Hospital Virgen del Puerto
🇪🇸Plasencia, Caceres, Spain
Fundacio ACE Institut Catala de Neurociences Aplicades
🇪🇸Barcelona, Spain
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States