Clinical trial NCT00998764: A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: antibody
immunotherapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 494
Sex: ALL
Minimum age (years): 51
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

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