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

NCT00998764 | Terminated Phase 3 Results DMC

• 3 other identifiers: 3133K1-3003B25210042009-015080-13
• Study Type: interventional
• Target: 494
• Locations: 19 countries
• Sites: 184

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.

Conditions

Alzheimer Disease

Keywords

antibody; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• 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

• 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

• Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.

  Base Study Baseline, Weeks 26, 52 and 78

Study Arms (1)

Bapineuzumab 0.5 mg/kg

EXPERIMENTAL

Drug: Bapineuzumab 0.5 mg/kg

Interventions

Bapineuzumab 0.5 mg/kg DRUG

I.V., 0.5 mg/kg, infusion every 13 weeks for a total of 16 infusions.

Also known as: AAB-001

Bapineuzumab 0.5 mg/kg

Eligibility Criteria

• Age: 51 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (184)

University Of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

UAB Center for Psychiatric Medicine

Birmingham, Alabama, 35294, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Dedicated Clinical Research

Goodyear, Arizona, 85395, United States

Location

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Banner Good Samaritan Medical Center (Imaging

Phoenix, Arizona, 85006, United States

Location

Jeffrey S. Gitt

Phoenix, Arizona, 85032, United States

Location

Hope Research Institute

Phoenix, Arizona, 85050, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

Alpine Clinical Research Center, Inc.

Boulder, Colorado, 80304, United States

Location

Associated Neurologist, PC

Boulder, Colorado, 80304, United States

Location

Mile High Research Center

Denver, Colorado, 80218, United States

Location

Associated Neurologists of Southern Connecticut, P.C.

Fairfield, Connecticut, 06824, United States

Location

Bendheim Infusion Center, Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

Center for Healthy Aging, Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, 06851, United States

Location

JEM Research LLC

Atlantis, Florida, 33462, United States

Location

Medical Specialists of the Palm Beaches

Atlantis, Florida, 33462, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Palm Beach Neurological Center, Advanced Research Consultants, Inc.

Palm Beach Gardens, Florida, 33418, United States

Location

Neurostudies, Inc

Port Charlotte, Florida, 33952, United States

Location

Southwest Florida Infusion Care, Inc.

Port Charlotte, Florida, 33952, United States

Location

Roskamp Institute

Sarasota, Florida, 34234, United States

Location

USF Health Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States

Location

Neuroscience Research Institute, LLC

Lawrenceville, Georgia, 30046, United States

Location

Neurostudies.net

Lawrenceville, Georgia, 30046, United States

Location

Alexian Brothers Neurosciences Institute Clinical Research

Elk Grove Village, Illinois, 60007, United States

Location

Southern Illinois University School of Medicine Department

Springfield, Illinois, 62702, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Neuroscience Research of the Berkshires

Pittsfield, Massachusetts, 01201, United States

Location

Springfield Neurology Associates, LLC

Springfield, Massachusetts, 01104, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Michigan State University

East Lansing, Michigan, 48848, United States

Location

Neurological Research Center of Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

The Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, 64114, United States

Location

Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, 07724, United States

Location

Alzheimer's Research Corp./Merician Institute for Aging

Paterson, New Jersey, 08759, United States

Location

Toms River X-Ray, CT & MRI

Toms River, New Jersey, 08755, United States

Location

MDR

Liverpool, New York, 13088, United States

Location

Neurological Care of Central New York

Liverpool, New York, 13088, United States

Location

Carolina Neuropsychological Services, Inc.

Raleigh, North Carolina, 27607, United States

Location

Healthsouth Blue Ridge Surgery Center

Raleigh, North Carolina, 27607, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Wake Radiology Associates

Raleigh, North Carolina, 27607, United States

Location

Ohio State Unviersity

Columbus, Ohio, 43210, United States

Location

Summit Research Network(Oregon) Inc.

Portland, Oregon, 97210, United States

Location

Providence Brain Institute-Cognitive Assessment Clinic

Portland, Oregon, 97225, United States

Location

Providence Brain Institute

Portland, Oregon, 97225, United States

Location

Abington Neurological Associates

Abington, Pennsylvania, 19001, United States

Location

Abington Neurological Assoc

Abington, Pennsylvania, 19001, United States

Location

Bington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Clinical Trial Center, LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

Medical University of South Carolina Hospitals and Clinics

Charleston, South Carolina, 29245, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

Location

Texas Neurology, P.A.

Dallas, Texas, 75214, United States

Location

Innovative Clinical Trials

San Antonio, Texas, 78229, United States

Location

Integra Clinical Research, LLC

San Antonio, Texas, 78231, United States

Location

Vista Infusions

San Antonio, Texas, 78231, United States

Location

Inventive Infusion Solutions

San Antonio, Texas, 78258, United States

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Gosford Hospital; Pharmacy Dept

Gosford, New South Wales, 2250, Australia

Location

Hornsby Hospital

Hornsby, New South Wales, 2207, Australia

Location

Royal Adelaide Memory Trials Centre

Adelaide, South Australia, 5000, Australia

Location

Memory Unit 5C, Department of Neurology

Woodville South, South Australia, 5011, Australia

Location

The Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia

Location

Heidelberg Repatriation Hospital

Heidelberg West, Victoria, 3081, Australia

Location

Hollywood Hospital; Pharmacy Dept

Nedlands, Western Australia, 6009, Australia

Location

The McCusker Foundation for Alzheimer's Disease Research

Nedlands, Western Australia, 6009, Australia

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

AZ Sint-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gasthuisberg

Leuven, 3000, Belgium

Location

H.-Hartziekenhuis Roeselare-Menen

Roeselare, 8800, Belgium

Location

Psicomedica Research Group

Santiago, Chile, 7530193, Chile

Location

Ita-Suomen Yliopisto

Kuopio, FIN-70210, Finland

Location

University of Turku/CRST

Turku, FIN-20520, Finland

Location

CHU de Dijon

Dijon, France, 21000, France

Location

Hôpital Roger Salengro

Lille, France, 59037, France

Location

Hôpital Pitié-Salpétrière

Paris, France, 75013, France

Location

CHU Hôpital Pellegrin-Tripode

Bordeaux, 33076, France

Location

Hopital Neurologique

Bron, 69677, France

Location

CHU de Caen

Caen, 14033, France

Location

Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

Hôpital la Timone

Marseille, 13385, France

Location

Hôpital la Timone

Marseille, 13885, France

Location

CHU Hôpital Gui de Chaulliac

Montpellier, 34295, France

Location

CHU Nord - Hôpital Guillaume et René Laënnec

Nantes - Saint Herblain, 44093, France

Location

Hôpital Cimiez

Nice, 06000, France

Location

CHU La Milétrie

Poitiers, 86021, France

Location

C.H.U de Reims

Reims, 51000, France

Location

Department de Radiologie et d'Imagerie Medicale, Hopital Pontchaillou

Rennes, 35033, France

Location

CHRU Hôtel Dieu

Rennes, 35064, France

Location

Centre Hospitalier Universitaire Charles Nicolle

Rouen, 76031, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

CHU Purpan - Hôpital Casselardit

Toulouse, 31300, France

Location

Sezione di Neurologia - Dipartimento di Neuroscienze

Ancona, 60020, Italy

Location

Dipartimento di Neuroscienze,

Catania, 95123, Italy

Location

Fondazione IRCCS- Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Unita' Operativa C - Riabilitazione Neurologica

Roma, 00179, Italy

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Yachiyo Hospital

Aichi, 446-8510, Japan

Location

Kashiwado Hospital

Chiba, 260-8656, Japan

Location

National Hospital Organization Chiba-East Hospital

Chiba, 260-8712, Japan

Location

Nippon Medical School Chiba Hokusoh Hospital

Chiba, 270-1694, Japan

Location

National Hospital Organization Kokura Medical Center

Fukuoka, 802-8533, Japan

Location

Maebashi Red Cross Hospital

Gunma, 371-0014, Japan

Location

Gunma University Hospital

Gunma, 371-8511, Japan

Location

Shinozuka Hospital

Gunma, 375-0017, Japan

Location

National Hospital Organization Hiroshima-nishi Medical Ctr.

Hiroshima, 739-0696, Japan

Location

Kobe University Hospital

Hyōgo, 650-0017, Japan

Location

Kagawa University Hospital

Kagawa, 761-0793, Japan

Location

Nippon Medical School Musashi Kosugi Hospital

Kanagawa, 211-8533, Japan

Location

Rakuwakai Otowa Hospital

Kyoto, 607-8062, Japan

Location

National Hospital Organization Minami-Kyoto Hospital

Kyoto, 610-0113, Japan

Location

National Hospital Organization Maizuru Medical Center

Kyoto, 625-8502, Japan

Location

National Hospital Organization Matsumoto Medical Center

Nagano, 399-0021, Japan

Location

National Hospital Organization Niigata National Hospital

Niigata, 945-8585, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

National Hospital Organization Minami-Okayama Medical Center

Okayama, 701-0304, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

Kansai Medical University Takii Hospital

Osaka, 570-8507, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Juntendo Tokyo Koto Geriatric Medical Center

Tokyo, 136-0075, Japan

Location

Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp

Tokyo, 145-0065, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, 193-0944, Japan

Location

National Hospital Organization Tokyo National Hospital

Tokyo, 204-8585, Japan

Location

Geriatry

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

The Memory Clinic Limited

Auckland, 0622, New Zealand

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Signet Research

Christchurch, 8014, New Zealand

Location

NZOZ Neuro-kard

Poznan, Poland, 61-289, Poland

Location

Pallmed Spolka z o.o.

Bydgoszcz, 85-796, Poland

Location

MCD Voxel

Poznan, 60-693, Poland

Location

Pracownia Rezonansu Magnetycznego

Warsaw, 01-211, Poland

Location

SP ZOZ Szpital Wolski

Warsaw, 01-211, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny

Warsaw, 02-097, Poland

Location

Hospitais Da Universidade De Coimbra

Coimbra, Coimbra District, 3000-075, Portugal

Location

Hospital Fernando da Fonseca

Amadora, Lisbon District, 2720-276, Portugal

Location

Hospital Santa Maria

Lisbon, Lisbon District, 1649-028, Portugal

Location

Univerzitna nemocnica Bratislava

Bratislava, 825 56, Slovakia

Location

Vseobecna nemocnica Rimavska Sobota

Rimavská Sobota, 979 12, Slovakia

Location

Boithuso Caregivers

Johannesburg, Gauteng, 1709, South Africa

Location

The Osteoporosis and Memory Centre

Johannesburg, Gauteng, 2196, South Africa

Location

St Augustine's Medical Centre 2

Durban, KwaZulu-Natal, 4001, South Africa

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

CLONUS

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Fundacio ACE Institut Catala de Neurociences Aplicades

Barcelona, Barcelona, 08014, Spain

Location

Clinica CIMA

Barcelona, Barcelona, 08034, Spain

Location

Hospital Mutua de Terrasa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Divino Valles

Burgos, Burgos, 09006, Spain

Location

Hospital Virgen del Puerto

Plasencia, Caceres, 10600, Spain

Location

Hospital de la Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Malmo University Hospital

Malmo, 21 224, Sweden

Location

Minnes- och geriatrikmottagningen

Uppsala, 75185, Sweden

Location

Memory Clinic Neuro-Psychologie Zentrum

Basel, Canton of Basel-City, CH-4031, Switzerland

Location

Memory Service North, Grenoside Grange Hospital

Grenoside, Sheffield, S35 8QS, United Kingdom

Location

Llandough Hospital, Universtity Hospital of Wales

Cardiff, Wales, CF4 4XW, United Kingdom

Location

MAC UK Neuroscience Ltd.

Bradford, BDQ0DQ, United Kingdom

Location

Clinical Investigation and Research Unit (CIRU)

Brighton, BN2 5BE, United Kingdom

Location

Glasgow Memory Clinic

Glasgow, G20 OXA, United Kingdom

Location

Dept. of Neurosciences Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

The Doctors Laboratory Ltd.

London, WIT 4EU, United Kingdom

Location

Newcastle General Hospital

Newcastle upon Tyne, NE4 5PL, United Kingdom

Location

Northampton General Hospital

Northampton, NN1 5BD, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Victoria Hospital

Swindon, SN3 6BW, United Kingdom

Location

Alliance Medical

Wakefield, WF1 4TT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27334799 DERIVED

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease

Interventions

bapineuzumab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: October 20, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 1, 2016
• Results First Posted: January 1, 2016

Record last verified: 2015-11

Locations

IT (4); FI (2); JP (28); NL (4); ZA (3); SE (2); ES (14); PT (3); FR (19); AR (1); AU (8); US (66); NZ (3); CH (1); PL (6); GB (12); SL (2); CL (1); BE (5)