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Alzheimer DiseasePhase 3NCT00998764

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

A Phase 3 study testing Bapineuzumab 0.5 mg/kg in people with Alzheimer Disease, run by Pfizer at 184 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 51 to 90 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Bapineuzumab 0.5 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
494 participants
Where
184 sitesin 19 countries
Study dates
Dec 2009to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 51 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

184 sites in 19 countries.

184 sites in 19 countries

United States66 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • Abington Neurological Assoc

    Abington, Pennsylvania, 19001

  • Bington Memorial Hospital

    Abington, Pennsylvania, 19001

  • JEM Research LLC

    Atlantis, Florida, 33462

  • Medical Specialists of the Palm Beaches

    Atlantis, Florida, 33462

  • University Of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • UAB Center for Psychiatric Medicine

    Birmingham, Alabama, 35294

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Alabama-Birmingham

    Birmingham, Alabama, 35294

  • Alpine Clinical Research Center, Inc.

    Boulder, Colorado, 80304

  • Associated Neurologist, PC

    Boulder, Colorado, 80304

  • Medical University of South Carolina Hospitals and Clinics

    Charleston, South Carolina, 29245

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Ohio State Unviersity

    Columbus, Ohio, 43210

  • Texas Neurology, P.A.

    Dallas, Texas, 75214

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • Michigan State University

    East Lansing, Michigan, 48824

  • Michigan State University

    East Lansing, Michigan, 48848

  • Rhode Island Mood and Memory Research Institute

    East Providence, Rhode Island, 02914

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Neurosciences Institute Clinical Research

    Elk Grove Village, Illinois, 60007

  • Associated Neurologists of Southern Connecticut, P.C.

    Fairfield, Connecticut, 06824

  • Dedicated Clinical Research

    Goodyear, Arizona, 85395

  • Bendheim Infusion Center, Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Center for Healthy Aging, Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Neurological Research Center of Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • The Center for Pharmaceutical Research, P.C.

    Kansas City, Missouri, 64114

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • Neuroscience Research Institute, LLC

    Lawrenceville, Georgia, 30046

  • Neurostudies.net

    Lawrenceville, Georgia, 30046

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205

  • MDR

    Liverpool, New York, 13088

  • Neurological Care of Central New York

    Liverpool, New York, 13088

  • Medical University of South Carolina

    North Charleston, South Carolina, 29406

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Palm Beach Neurological Center, Advanced Research Consultants, Inc.

    Palm Beach Gardens, Florida, 33418

  • Alzheimer's Research Corp./Merician Institute for Aging

    Paterson, New Jersey, 08759

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Banner Good Samaritan Medical Center (Imaging

    Phoenix, Arizona, 85006

  • Jeffrey S. Gitt

    Phoenix, Arizona, 85032

  • Hope Research Institute

    Phoenix, Arizona, 85050

  • Neuroscience Research of the Berkshires

    Pittsfield, Massachusetts, 01201

  • Neurostudies, Inc

    Port Charlotte, Florida, 33952

  • Southwest Florida Infusion Care, Inc.

    Port Charlotte, Florida, 33952

  • Summit Research Network(Oregon) Inc.

    Portland, Oregon, 97210

  • Providence Brain Institute-Cognitive Assessment Clinic

    Portland, Oregon, 97225

  • Providence Brain Institute

    Portland, Oregon, 97225

  • Carolina Neuropsychological Services, Inc.

    Raleigh, North Carolina, 27607

  • Healthsouth Blue Ridge Surgery Center

    Raleigh, North Carolina, 27607

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • Wake Radiology Associates

    Raleigh, North Carolina, 27607

  • Innovative Clinical Trials

    San Antonio, Texas, 78229

  • Integra Clinical Research, LLC

    San Antonio, Texas, 78231

  • Vista Infusions

    San Antonio, Texas, 78231

  • Inventive Infusion Solutions

    San Antonio, Texas, 78258

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • Roskamp Institute

    Sarasota, Florida, 34234

  • Southern Illinois University School of Medicine Department

    Springfield, Illinois, 62702

  • Springfield Neurology Associates, LLC

    Springfield, Massachusetts, 01104

  • USF Health Byrd Alzheimer's Institute

    Tampa, Florida, 33613

  • Toms River X-Ray, CT & MRI

    Toms River, New Jersey, 08755

Other trials in United States

Japan28 sites

  • Yachiyo Hospital

    Aichi, 446-8510

  • Kashiwado Hospital

    Chiba, 260-8656

  • National Hospital Organization Chiba-East Hospital

    Chiba, 260-8712

  • Nippon Medical School Chiba Hokusoh Hospital

    Chiba, 270-1694

  • National Hospital Organization Kokura Medical Center

    Fukuoka, 802-8533

  • Maebashi Red Cross Hospital

    Gunma, 371-0014

  • Gunma University Hospital

    Gunma, 371-8511

  • Shinozuka Hospital

    Gunma, 375-0017

  • National Hospital Organization Hiroshima-nishi Medical Ctr.

    Hiroshima, 739-0696

  • Kobe University Hospital

    Hyōgo, 650-0017

  • Kagawa University Hospital

    Kagawa, 761-0793

  • Nippon Medical School Musashi Kosugi Hospital

    Kanagawa, 211-8533

  • Rakuwakai Otowa Hospital

    Kyoto, 607-8062

  • National Hospital Organization Minami-Kyoto Hospital

    Kyoto, 610-0113

  • National Hospital Organization Maizuru Medical Center

    Kyoto, 625-8502

  • National Hospital Organization Matsumoto Medical Center

    Nagano, 399-0021

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • National Hospital Organization Niigata National Hospital

    Niigata, 945-8585

  • Okayama University Hospital

    Okayama, 700-8558

  • National Hospital Organization Minami-Okayama Medical Center

    Okayama, 701-0304

  • Osaka City University Hospital

    Osaka, 545-8586

  • Kansai Medical University Takii Hospital

    Osaka, 570-8507

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Juntendo Tokyo Koto Geriatric Medical Center

    Tokyo, 136-0075

  • Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp

    Tokyo, 145-0065

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0944

  • National Hospital Organization Tokyo National Hospital

    Tokyo, 204-8585

Other trials in Japan

France19 sites

  • CHU Hôpital Pellegrin-Tripode

    Bordeaux, 33076

  • Hopital Neurologique

    Bron, 69677

  • CHU de Caen

    Caen, 14033

  • Hôpitaux Civils de Colmar

    Colmar, 68024

  • CHU de Dijon

    Dijon, France, 21000

  • Hôpital Roger Salengro

    Lille, France, 59037

  • Hôpital la Timone

    Marseille, 13385

  • Hôpital la Timone

    Marseille, 13885

  • CHU Hôpital Gui de Chaulliac

    Montpellier, 34295

  • CHU Nord - Hôpital Guillaume et René Laënnec

    Nantes - Saint Herblain, 44093

  • Hôpital Cimiez

    Nice, 06000

  • Hôpital Pitié-Salpétrière

    Paris, France, 75013

  • CHU La Milétrie

    Poitiers, 86021

  • C.H.U de Reims

    Reims, 51000

  • Department de Radiologie et d'Imagerie Medicale, Hopital Pontchaillou

    Rennes, 35033

  • CHRU Hôtel Dieu

    Rennes, 35064

  • Centre Hospitalier Universitaire Charles Nicolle

    Rouen, 76031

  • Hôpital Purpan

    Toulouse, 31059

  • CHU Purpan - Hôpital Casselardit

    Toulouse, 31300

Other trials in France

Spain14 sites

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Fundacio ACE Institut Catala de Neurociences Aplicades

    Barcelona, Barcelona, 08014

  • Clinica CIMA

    Barcelona, Barcelona, 08034

  • Hospital Divino Valles

    Burgos, Burgos, 09006

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital de la Princesa

    Madrid, Madrid, 28006

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital de la Princesa

    Madrid, 28006

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • CLONUS

    Palma de Mallorca, Balearic Islands, 07014

  • Hospital Virgen del Puerto

    Plasencia, Caceres, 10600

  • Hospital Mutua de Terrasa

    Terrassa, Barcelona, 08221

Other trials in Spain

United Kingdom12 sites

  • MAC UK Neuroscience Ltd.

    Bradford, BDQ0DQ

  • Clinical Investigation and Research Unit (CIRU)

    Brighton, BN2 5BE

  • Llandough Hospital, Universtity Hospital of Wales

    Cardiff, Wales, CF4 4XW

  • Glasgow Memory Clinic

    Glasgow, G20 OXA

  • Memory Service North, Grenoside Grange Hospital

    Grenoside, Sheffield, S35 8QS

  • Dept. of Neurosciences Charing Cross Hospital

    London, W6 8RF

  • The Doctors Laboratory Ltd.

    London, WIT 4EU

  • Newcastle General Hospital

    Newcastle upon Tyne, NE4 5PL

  • Northampton General Hospital

    Northampton, NN1 5BD

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Victoria Hospital

    Swindon, SN3 6BW

  • Alliance Medical

    Wakefield, WF1 4TT

Other trials in United Kingdom

Australia8 sites

  • Royal Adelaide Memory Trials Centre

    Adelaide, South Australia, 5000

  • Gosford Hospital; Pharmacy Dept

    Gosford, New South Wales, 2250

  • Heidelberg Repatriation Hospital

    Heidelberg West, Victoria, 3081

  • Hornsby Hospital

    Hornsby, New South Wales, 2207

  • Hollywood Hospital; Pharmacy Dept

    Nedlands, Western Australia, 6009

  • The McCusker Foundation for Alzheimer's Disease Research

    Nedlands, Western Australia, 6009

  • Memory Unit 5C, Department of Neurology

    Woodville South, South Australia, 5011

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Poland6 sites

  • Pallmed Spolka z o.o.

    Bydgoszcz, 85-796

  • NZOZ Neuro-kard

    Poznan, Poland, 61-289

  • MCD Voxel

    Poznan, 60-693

  • Pracownia Rezonansu Magnetycznego

    Warsaw, 01-211

  • SP ZOZ Szpital Wolski

    Warsaw, 01-211

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Warsaw, 02-097

Other trials in Poland

Belgium5 sites

  • ZNA Middelheim

    Antwerp, 2020

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, 8000

  • Cliniques Universitaires St Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gasthuisberg

    Leuven, 3000

  • H.-Hartziekenhuis Roeselare-Menen

    Roeselare, 8800

Other trials in Belgium

Italy4 sites

  • Sezione di Neurologia - Dipartimento di Neuroscienze

    Ancona, 60020

  • Dipartimento di Neuroscienze,

    Catania, 95123

  • Fondazione IRCCS- Istituto Neurologico Carlo Besta

    Milan, 20133

  • Unita' Operativa C - Riabilitazione Neurologica

    Roma, 00179

Other trials in Italy

Netherlands4 sites

  • Geriatry

    's-Hertogenbosch, 5223 GZ

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1081 HV

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

Other trials in Netherlands

New Zealand3 sites

  • The Memory Clinic Limited

    Auckland, 0622

  • Christchurch Hospital

    Christchurch, 8011

  • Signet Research

    Christchurch, 8014

Other trials in New Zealand

Portugal3 sites

  • Hospital Fernando da Fonseca

    Amadora, Lisbon District, 2720-276

  • Hospitais Da Universidade De Coimbra

    Coimbra, Coimbra District, 3000-075

  • Hospital Santa Maria

    Lisbon, Lisbon District, 1649-028

Other trials in Portugal

South Africa3 sites

  • St Augustine's Medical Centre 2

    Durban, KwaZulu-Natal, 4001

  • Boithuso Caregivers

    Johannesburg, Gauteng, 1709

  • The Osteoporosis and Memory Centre

    Johannesburg, Gauteng, 2196

Other trials in South Africa

Finland2 sites

  • Ita-Suomen Yliopisto

    Kuopio, FIN-70210

  • University of Turku/CRST

    Turku, FIN-20520

Other trials in Finland

Slovakia2 sites

  • Univerzitna nemocnica Bratislava

    Bratislava, 825 56

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 12

Other trials in Slovakia

Sweden2 sites

  • Malmo University Hospital

    Malmö, 21 224

  • Minnes- och geriatrikmottagningen

    Uppsala, 75185

Other trials in Sweden

Argentina1 site

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

Other trials in Argentina

Chile1 site

  • Psicomedica Research Group

    Santiago, Chile, 7530193

Other trials in Chile

Switzerland1 site

  • Memory Clinic Neuro-Psychologie Zentrum

    Basel, Canton of Basel-City, CH-4031

Other trials in Switzerland

About this study

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.

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.

Being tested
Bapineuzumab 0.5 mg/kg
Keywords
antibody, immunotherapy
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bapineuzumab 0.5 mg/kgDrug

    Also called AAB-001

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

Study groups in NCT00998764
Study groupRoleWhat they receive
Bapineuzumab 0.5 mg/kgExperimentalNot described
Receives: Drug: Bapineuzumab 0.5 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to Week 195

Secondary outcomes (8)

  1. 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.

    Measured: Base Study Baseline, Weeks 13, 26, 39, 52 and 78

  2. 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.

    Measured: Base Study Baseline, Weeks 13, 26, 39, 52 and 78

  3. 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.

    Measured: Base Study Baseline, Weeks 13, 26, 39, 52 and 78

  4. 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.

    Measured: Base Study Baseline, Weeks 13, 26, 39, 52 and 78

  5. 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.

    Measured: Base Study Baseline, Weeks 26, 52 and 78

  6. 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.

    Measured: Base Study Baseline, Weeks 26, 52 and 78

  7. 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.

    Measured: Base Study Baseline, Weeks 6, 19, 32, 45 and 78

  8. 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.

    Measured: Base Study Baseline, Weeks 6, 19, 32, 45 and 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionOct 2012
  4. Study completionNov 2012

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00998764
Sponsor's protocol ID
3133K1-3003
Other IDs
B2521004, 2009-015080-13, 2009
Status last verified
Nov 2015
First submitted
16 Oct 2009
Last updated
1 Jan 2016
Data monitoring committee
Yes

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.

    PubMed 27334799

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bapineuzumab 0.5 mg/kg in people with Alzheimer Disease, run by Pfizer at 184 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Japan, France, Spain, United Kingdom and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting a Serious Adverse Event (time frame: Up to Week 195). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00998764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.

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