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Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bapineuzumab
bapineuzumab
placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring antibody, immunotherapy

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD
  • Concurrent use of cholinesterase inhibitor or memantine allowed, if stable
  • Caregiver will participate and be able to attend clinic visits with patient

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body]
  • Women of childbearing potential

Sites / Locations

  • University of Alabama-Birmingham
  • Dedicated Clinical Research
  • Banner Alzheimer's Institute
  • Jeffrey S. Gitt, DO, PC
  • The Compounding Center (IP Mixing Only)
  • Hope Research Institute
  • Clinical Trials, Inc.
  • ATP Clinical Research, Incorporated
  • Pharmacology Research Institute
  • Margolin Brain Institute
  • Infusion Care Pharmacey
  • Senior Clinical Trials, Incorporated
  • Faculty Physicians and Surgeons of Loma Linda University School of Medicine
  • Loma Linda University Medical Center
  • Collaborative Neuroscience Network, Inc.
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • Coordinated Clinical Research
  • LabCorp
  • Sharp and Children's MRI Center, LLC
  • Sharp Infusion Therapy Center
  • Sharp Memorial Hospital
  • Sharp Mesa Vista Hospital
  • San Francisco Clinical Research Center
  • Alpine Clinical Research Center, Inc.
  • Associated Neurologists, PC
  • The Mile High Research Center
  • Associated Neurologists, PC
  • Associated Neurologists of Southern Connecticut, P.C.
  • Bendheim Cancer Center
  • Center for Healthy Aging
  • Institute for Neurodegenerative Disorders
  • Yale University School of Medicine
  • Yale-New Haven Hospital
  • Yale-New Haven Hospital
  • Norman S. Werdiger, MD
  • Institutional Review Board / Ethics Committee
  • Yale PET Center
  • Yale University School of Medicine
  • Research Center for Clinical Studies, Inc.
  • Chase Medical Research, LLC
  • JEM Research Institute LLC
  • Medical Specialists of the Palm Beaches
  • Bradenton Research Center, Incorporated
  • North Broward Medical Center
  • Brain Matters Research
  • Neurologic Consultants, P.A.
  • MD Clinical
  • Renstar Medical Research
  • Advanced Imaging
  • Compass Research, LLC
  • Palm Beach Neurological Center
  • Neurostudies Inc
  • Roskamp Institute
  • South Bay Internal Medicine
  • Stedman Clinical Trials, LLC
  • Premiere Research Institute
  • NeuroTrials Research, Incorporated
  • Columbus Diagnostic Center (MRI)
  • Medical Research and Health Education Foundation, Incorporated
  • Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC
  • NeuroStudies.net
  • Neurostudies.net
  • Neurostudies.net
  • Alexian Brothers Medical Center
  • Alexian Brothers Neurosciences Institute
  • Methodist Center for Senior Health
  • Methodist Medical Center Research Department
  • Methodist Diagnostic Center
  • Methodist Medical Center of Illinois
  • Southern Illinois University School of Medicine
  • Memorial Medical Center
  • Elkhart Clinic, LLC
  • Psychology Associates
  • KU - Wichita
  • Drug Shipment/ Storage
  • Four Rivers Clinical Research, Incorporated
  • Radio Pharmacy
  • Lake Charles Clinical Trials
  • Louisiana Research Associates Inc
  • James Gary Booker, MD, APMC
  • Foers Medical Arts Pharmacy
  • CBH Health, LLC
  • Massachusetts General Hospital
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Bringham and Women's Hospital
  • Boston University
  • General Clinical Research Center
  • IDS Pharmacy
  • ActivMed Practices and Research, Inc.
  • Neurocare, Incorporated
  • Springfield Neurology Associates, LLC
  • University of Michigan Health System
  • University of Michigan Hospital
  • University of Michigan Health System
  • Michigan State University
  • Michigan State University
  • Marty's Pharmacy
  • Precise Research Centers
  • Hattiesburg Clinic
  • The Center for Pharmaceutical Research
  • Advanced Neurology Specialists
  • Spectrum Home Solutions
  • Comprehensive Clinical Research
  • Memory Enhancement Center of America, Inc.
  • Alzheimer's Research Corporation
  • Memory Enhancement Center of New Jersey, Inc.
  • Northeast Radiology
  • Neurological Care of Central New York
  • AD-CARE, University of Rochester Medical Center
  • University of Rochester/Strong Memorial Hospital
  • Clinical Study Center of Asheville, LLC
  • Alzheimer's Memory Center
  • Clinical Trials of America, Incorporated
  • The Compounding Pharmacy
  • Carolina Neuropsychological Services, Inc.
  • Healthsouth Blue Ridge Surgery Center
  • Raleigh Neurology Associates, PA
  • Wake Radiology Associates
  • Ohio State University Imaging at Martha Morehouse
  • The Ohio State University Hospitals Clinic
  • The Ohio State University Medical Center
  • The Ohio State University
  • Neurology & Neuroscience Center of Ohio
  • Professional Corporation of Psychiatry
  • Red River Medical Recearch Center, LLC
  • Flourish Integrative Pharmacy
  • Providence Brain Institute
  • Abington Memorial Hospital
  • Abington Neurological Associates
  • Clinical Trial Center, LLC
  • Hospital of the University of Pennslyvania
  • Hospital of the University of Pennsylvania (PET)
  • Hospital of the University of Pennsylvania
  • Investigational New Drug Services, IDS Pharmacy
  • Penn Memory Center
  • UPENN Clinical and Translational Research Center (CTRC)
  • Clinical Trials Research Services, LLC
  • Abington Neurological Associates
  • Rhode Island Mood and Memory Research Institute
  • Simpson's Pharmacy
  • Butler Hospital
  • Medical University of South Carolina Hospitals and Clinics
  • Medical University of South Carolina Investigational Drug Service
  • Radiant Research, Incorporated
  • Medical University of South Carolina
  • Neurology Clinic, PC
  • Austin Infusion Centers
  • Senior Adults Specialty Research
  • Texas Neurology, P.A.
  • University of North Texas Health Science Center
  • Innovative Clinical Trials
  • Integra Clinical Research, LLC
  • Vista Infusions
  • Inventive Infusion Solutions
  • Grayline Clinical Drug Trials
  • Southwestern Vermont Healthcare
  • The Memory Clinic
  • University of Virginia Neurology
  • University of Virginia General Clinical Research Center
  • University of Viriginia Investigational Pharmacy
  • Pacific Medical Centers
  • Pacific Medical Centers
  • Cemic University Hospital
  • Hospital Italiano de Buenos Aires
  • Gosford Hospital
  • Hornsby Kuringai Hospital
  • The Queen Elizabeth Hospital
  • CDAMS Ballarat Base Hospital
  • Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit
  • Hollywood Private Hospital
  • McCusker Alzheimer's Research Foundation Inc.
  • Royal Adelaide Hospital
  • ZNA Middelheim / Neurologie
  • Az. St. Jan Ruddershove 35
  • Cliniques Universitaires Saint-Luc
  • Universitair Ziekenhuis Antwerpen
  • University Hospital Gathuisberg
  • H.-Hartziekenhuis Roeselare-Menen
  • Centre for Memory and Aging
  • Bruyere Continuing Care
  • Toronto Memory Program
  • Sunnybrook Health Sciences Centre
  • Centre de Recherche ADAPRA Inc.
  • Hopital Maisonneuve-Rosemont
  • Recherche Clinique de Neurologie
  • Diex Research Sherbrooke Inc.
  • ALPHA Recherche Clinique
  • Psicomedica Research Group
  • Especialidades Medicas L&S
  • Sestre milosrdnice Zagreb
  • University Hospital Center Zagreb
  • Ita-Suomen Yliopisto
  • Turku University Hospital
  • CHRU Hôtel Dieu
  • CHU Hopital Nord
  • Hôpital Neurologique
  • CHU de Caen
  • Hôpitaux Civils de Colmar
  • CHU de Dijon
  • Hôpital Roger Salengro
  • Hopital Sainte Marguerite
  • Hôpital la Timone
  • CHU Hôpital Gui de Chaulliac
  • CHU Nord - Hôpital Guillaume et René Laënnec
  • Hôpital Cimiez
  • Groupe Hospitalier Pitie-Salpetriere
  • Groupe Hospitalier Broca-La Rochefoucauld
  • CHU La Milétrie
  • C.H.U de Reims
  • CHU - Hopital Charles Nicolle
  • Hôpital Purpan
  • CHU Purpan - Hôpital Casselardit
  • Klinik fur Psychiatrie und Psychotherapie
  • St. Josef-Klinikum
  • Ortenau Klinikum
  • Universitaet Regensburg
  • Universita Politecnica delle Marche
  • Azienda Ospedaliera Spedali Civili di Brescia
  • Unita' Operativa Complessa di Neurologia
  • CeSI (Centro di Scienze dell'invecchiamento) -
  • Universita degli Studi di Firenze
  • Ospedale S. Raffaele
  • Ospedale S. Raffaele
  • Fondazione IRCCS- Istituto Neurologico Carlo Besta
  • Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca
  • Ospedale S. Gerardo
  • Clinica Neurologica
  • Unita' Operativa C - Riabilitazione Neurologica
  • Universita degli Studi di Siena
  • Nagoya City University Hospital
  • Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp
  • Yachiyo Hospital
  • Kashiwado Hospital
  • National Hospital Organization Chiba-East Hospital
  • Nippon Medical School Chiba Hokusoh Hospital
  • National Hospital Organization Kokura Medical Center
  • Maebashi Red Cross Hospital
  • Gunma University Hospital
  • Shinozuka Hospital
  • National Hospital Organization Hiroshima-nishi Medical Ctr.
  • Kobe University Hospital
  • Nishi-Kobe Medical Center
  • Kobe City Hospital Org Kobe City Medical Cente West Hp
  • Iwate Medical University Hospital
  • Kagawa University Hospital
  • Nippon Medical School Musashikosugi Hospital
  • Yokohama City University Medical Center
  • Shonan Atsugi Hospital
  • Rakuwakai Otowa Hospital
  • National Hospital Organization Minami-Kyoto Hospital
  • National Hospital Organization Maizuru Medical Center
  • National Hospital Organization Matsumoto Medical Center
  • National Hospital Organization Niigata National Hospital
  • Okayama University Hospital
  • National Hospital Organization Minami-Okayama Medical Center
  • Osaka City University Hospital
  • Osaka University Hospital
  • Kansai Medical University Takii Hospital
  • National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder
  • Juntendo University Hospital
  • Juntendo Tokyo Koto Geriatric Medical Center
  • Tokyo Medical University Hospital
  • Tokyo Medical University Hachioji Medical Center
  • National Hospital Organization Tokyo National Hospital
  • Seoul National University Bundang Hospital, Department of Psychiatry
  • KonKuk University Hospital, Department of NeuroPsychiatry
  • OCA Hospital
  • Instituto Biomedico de Investigacion A.C
  • Jeroen Bosch Ziekenhuis
  • Vrije Universiteit Medisch Centrum
  • Amphia Ziekenhuis
  • Catharina Ziekenhuis
  • Kennemer Gasthuis
  • Medisch Centrum Leeuwarden
  • Jeroen Bosch Ziekenhuis
  • The Memory Clinic
  • Signet Research
  • NZOZ Dom Suer Ryder, Pallmed Sp. z o.o.
  • NZOZ "SYNAPSA", ul. Niska 5/1
  • Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych
  • NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy
  • Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,
  • Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika
  • Hospital Fernando da Fonseca
  • Hospitais Da Universidade De Coimbra
  • Hospital Santa Maria
  • Interregional clinicodiagnostic center
  • Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko
  • Saint-Petersburg State institution of healthcare, City geriatric medico-social center
  • Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
  • Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
  • Chair of nervous system diseases
  • Klinicki centar Vojvodine
  • Klinicki centar Srbije
  • Klinicki centar Srbije
  • Clinical Centre Kragujevac
  • 1. Neurologicka klinika
  • Psychiatricka ambulancia
  • Univerzitna nemocnica Bratislava
  • Univerzitna nemocnica Bratislava
  • Neurologicka klinika
  • Psychiatricka nemocnica Michalovce, n.o.
  • Vseobecna nemocnica Rimavska Sobota
  • Neurologicke oddelenie FNsP Zilina
  • Boithuso Caregivers
  • The Osteoporosis and Memory Centre
  • Denmar Clinic
  • St Augustine's Medical Centre 2
  • Panorama Psychiatry and Memory Clinic
  • Hospital General Universitario de Elche
  • Hospital Mutua de Terrasa
  • Hospital Virgen del Puerto
  • Hospital Universitario Son Espases
  • CLONUS
  • Hospital de Cruces
  • Hospital del Mar
  • Fundació ACE Institut Catala de Neurociences Aplicades
  • Clínica CIMA
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Divino Valles
  • Hospital Universitario La Princesa
  • Hospital Universitario Ramon y Cajal
  • Hospital Clinico San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen de la Arrixaca
  • Skanes Universitetssjukhus, Neuropsykiatriska
  • PET center
  • The clinic: Minnes- och geriatrikmottagningen
  • MRI Dept: ORKI
  • Memory Clinic Neuro-Psychologie Zentrum
  • Hopitaux Universitaires de Geneve
  • CHUV Lausanne
  • Hopitaux Universitaires de Geneve
  • MAC UK Neuroscience Ltd
  • MAC UK Neuroscience, Ltd.
  • Clinical Investigation and Research Unit (CIRU)
  • Glasgow Memory Clinic
  • Kings College Hospital
  • Dept. of Neurosciences Charing Cross Hospital
  • Newcastle General Hospital
  • Northampton General Hospital NHS Trust
  • Llandough Hospital
  • Royal Hallamshire Hospital
  • Grenoside Grange Hospital
  • Kingshill Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Bapineuzumab 0.5 mg/kg

Bapineuzumab 1.0 mg/kg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 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.
The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78
The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.

Secondary Outcome Measures

The Change From Baseline in Brain Amyloid Burden at Week 71.
Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.
The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.
Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.
The Change From Baseline in Brain Volume at Week 71
Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.
Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.
Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.
Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.
Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)
The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.
Time to Median Placebo Deterioration on DAD Total Score
The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.
Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)
The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)
Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)
Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)
Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.
Change From Baseline in Dependence Scale Total Score at Week 78
The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78
The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.

Full Information

First Posted
April 24, 2008
Last Updated
December 4, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00667810
Brief Title
Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy And Safety Trial Of Bapineuzumab (Aab-001, Eln115727) In Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Non-carriers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
antibody, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
901 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bapineuzumab 0.5 mg/kg
Arm Type
Experimental
Arm Title
Bapineuzumab 1.0 mg/kg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
bapineuzumab
Other Intervention Name(s)
AAB-001
Intervention Description
Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Intervention Type
Drug
Intervention Name(s)
bapineuzumab
Other Intervention Name(s)
AAB-001
Intervention Description
Bapineuzumab 1.0 mg/kg administered by IV infusion approximately every 13 weeks through week 65.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo will be administered by IV infusion approximately every 13 weeks through week 65.
Primary Outcome Measure Information:
Title
The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78
Description
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.
Time Frame
78 weeks
Title
The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78
Description
The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.
Time Frame
78 weeks
Secondary Outcome Measure Information:
Title
The Change From Baseline in Brain Amyloid Burden at Week 71.
Description
Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer's pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.
Time Frame
71 Weeks
Title
The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.
Description
Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.
Time Frame
71 Weeks
Title
The Change From Baseline in Brain Volume at Week 71
Description
Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.
Time Frame
71 Weeks
Title
Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78
Description
The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.
Time Frame
39 Weeks
Title
Divergence of Effect on the DAD Total Scores From Week 39 to Week 78
Description
The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.
Time Frame
39 weeks
Title
Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)
Description
The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.
Time Frame
78 Weeks
Title
Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)
Description
The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.
Time Frame
78 weeks
Title
Time to Median Placebo Deterioration on DAD Total Score
Description
The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.
Time Frame
78 Weeks
Title
Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)
Description
The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.
Time Frame
78 Weeks
Title
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)
Description
Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.
Time Frame
78 Weeks
Title
Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)
Description
Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.
Time Frame
78 Weeks
Title
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)
Description
Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.
Time Frame
78 Weeks
Title
Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)
Description
Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.
Time Frame
78 weeks
Title
Change From Baseline in Dependence Scale Total Score at Week 78
Description
The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.
Time Frame
78 Weeks
Title
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78
Description
The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.
Time Frame
78 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (MRI) consistent with the diagnosis of AD Concurrent use of cholinesterase inhibitor or memantine allowed, if stable Caregiver will participate and be able to attend clinic visits with patient Exclusion Criteria: Significant neurological disease other than AD Major psychiatric disorder Contraindication to undergo brain MRI [e.g., pacemaker, cerebrospinal fluid (CSF) shunt, or foreign metal objects in the body] Women of childbearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Dedicated Clinical Research
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Jeffrey S. Gitt, DO, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
The Compounding Center (IP Mixing Only)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Clinical Trials, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
ATP Clinical Research, Incorporated
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Infusion Care Pharmacey
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Senior Clinical Trials, Incorporated
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Faculty Physicians and Surgeons of Loma Linda University School of Medicine
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Coordinated Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
LabCorp
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Sharp and Children's MRI Center, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Infusion Therapy Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Alpine Clinical Research Center, Inc.
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Associated Neurologists, PC
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
The Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Associated Neurologists, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Associated Neurologists of Southern Connecticut, P.C.
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Bendheim Cancer Center
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
Center for Healthy Aging
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Norman S. Werdiger, MD
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Institutional Review Board / Ethics Committee
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Yale PET Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
JEM Research Institute LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Medical Specialists of the Palm Beaches
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Bradenton Research Center, Incorporated
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
North Broward Medical Center
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Neurologic Consultants, P.A.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Advanced Imaging
City
Ocala
State/Province
Florida
ZIP/Postal Code
34481
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Palm Beach Neurological Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Neurostudies Inc
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
South Bay Internal Medicine
City
Sun City
State/Province
Florida
ZIP/Postal Code
33573
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
NeuroTrials Research, Incorporated
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Columbus Diagnostic Center (MRI)
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Medical Research and Health Education Foundation, Incorporated
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
NeuroStudies.net
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Neurostudies.net
City
Lawerenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Neurostudies.net
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Alexian Brothers Neurosciences Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Methodist Center for Senior Health
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Methodist Medical Center Research Department
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Methodist Diagnostic Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Elkhart Clinic, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Psychology Associates
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
KU - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Drug Shipment/ Storage
City
Wichitia
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Four Rivers Clinical Research, Incorporated
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Radio Pharmacy
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Louisiana Research Associates Inc
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
James Gary Booker, MD, APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Foers Medical Arts Pharmacy
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
CBH Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021147
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Bringham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
General Clinical Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
IDS Pharmacy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
ActivMed Practices and Research, Inc.
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Neurocare, Incorporated
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Springfield Neurology Associates, LLC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5872
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48110
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Michigan State University
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Marty's Pharmacy
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Advanced Neurology Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Spectrum Home Solutions
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Alzheimer's Research Corporation
City
Manchester
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
Facility Name
Memory Enhancement Center of New Jersey, Inc.
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Northeast Radiology
City
Brewster
State/Province
New York
ZIP/Postal Code
10509
Country
United States
Facility Name
Neurological Care of Central New York
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
AD-CARE, University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of Rochester/Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Clinical Study Center of Asheville, LLC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Clinical Trials of America, Incorporated
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
The Compounding Pharmacy
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Carolina Neuropsychological Services, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Healthsouth Blue Ridge Surgery Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Raleigh Neurology Associates, PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Radiology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Ohio State University Imaging at Martha Morehouse
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University Hospitals Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology & Neuroscience Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Professional Corporation of Psychiatry
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Red River Medical Recearch Center, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Flourish Integrative Pharmacy
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73134
Country
United States
Facility Name
Providence Brain Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Abington Neurological Associates
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Hospital of the University of Pennslyvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hospital of the University of Pennsylvania (PET)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Investigational New Drug Services, IDS Pharmacy
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Penn Memory Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPENN Clinical and Translational Research Center (CTRC)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Abington Neurological Associates
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Rhode Island Mood and Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Simpson's Pharmacy
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02861
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina Hospitals and Clinics
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina Investigational Drug Service
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Radiant Research, Incorporated
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Medical University of South Carolina
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Neurology Clinic, PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Austin Infusion Centers
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Texas Neurology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Innovative Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Integra Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Vista Infusions
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Inventive Infusion Solutions
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Southwestern Vermont Healthcare
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
University of Virginia Neurology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
University of Virginia General Clinical Research Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Viriginia Investigational Pharmacy
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Pacific Medical Centers
City
Bothell
State/Province
Washington
ZIP/Postal Code
98021
Country
United States
Facility Name
Pacific Medical Centers
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
Facility Name
Cemic University Hospital
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Hornsby Kuringai Hospital
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
02077
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
CDAMS Ballarat Base Hospital
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3353
Country
Australia
Facility Name
Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit
City
West Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Hollywood Private Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
McCusker Alzheimer's Research Foundation Inc.
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide SA
ZIP/Postal Code
5000
Country
Australia
Facility Name
ZNA Middelheim / Neurologie
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Az. St. Jan Ruddershove 35
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
University Hospital Gathuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
H.-Hartziekenhuis Roeselare-Menen
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Centre for Memory and Aging
City
North York
State/Province
Ontario
ZIP/Postal Code
M6M 3Z5
Country
Canada
Facility Name
Bruyere Continuing Care
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Centre de Recherche ADAPRA Inc.
City
L'Ancienne-Lorette
State/Province
Quebec
ZIP/Postal Code
G2E 2X1
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Recherche Clinique de Neurologie
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
ALPHA Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Psicomedica Research Group
City
Santiago
ZIP/Postal Code
7530193
Country
Chile
Facility Name
Especialidades Medicas L&S
City
Santiago
Country
Chile
Facility Name
Sestre milosrdnice Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Ita-Suomen Yliopisto
City
Kuopio
ZIP/Postal Code
FIN-70210
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
CHRU Hôtel Dieu
City
Rennes
State/Province
Cedex
ZIP/Postal Code
35064
Country
France
Facility Name
CHU Hopital Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hôpital Neurologique
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Sainte Marguerite
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hôpital la Timone
City
Marseille
ZIP/Postal Code
13885
Country
France
Facility Name
CHU Hôpital Gui de Chaulliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nord - Hôpital Guillaume et René Laënnec
City
Nantes - Saint Herblain
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Cimiez
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Groupe Hospitalier Broca-La Rochefoucauld
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU La Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
C.H.U de Reims
City
Reims
ZIP/Postal Code
51000
Country
France
Facility Name
CHU - Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Purpan - Hôpital Casselardit
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Klinik fur Psychiatrie und Psychotherapie
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
St. Josef-Klinikum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Ortenau Klinikum
City
Offenburg
ZIP/Postal Code
77654
Country
Germany
Facility Name
Universitaet Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universita Politecnica delle Marche
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Unita' Operativa Complessa di Neurologia
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
CeSI (Centro di Scienze dell'invecchiamento) -
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Universita degli Studi di Firenze
City
Firenze
ZIP/Postal Code
50131
Country
Italy
Facility Name
Ospedale S. Raffaele
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Ospedale S. Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS- Istituto Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Ospedale S. Gerardo
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Clinica Neurologica
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Unita' Operativa C - Riabilitazione Neurologica
City
Roma
ZIP/Postal Code
00179
Country
Italy
Facility Name
Universita degli Studi di Siena
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi,
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
145-0065
Country
Japan
Facility Name
Yachiyo Hospital
City
Aichi
ZIP/Postal Code
446-8510
Country
Japan
Facility Name
Kashiwado Hospital
City
Chiba
ZIP/Postal Code
260-8656
Country
Japan
Facility Name
National Hospital Organization Chiba-East Hospital
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Nippon Medical School Chiba Hokusoh Hospital
City
Chiba
ZIP/Postal Code
270-1694
Country
Japan
Facility Name
National Hospital Organization Kokura Medical Center
City
Fukuoka
ZIP/Postal Code
802-8533
Country
Japan
Facility Name
Maebashi Red Cross Hospital
City
Gunma
ZIP/Postal Code
371-0014
Country
Japan
Facility Name
Gunma University Hospital
City
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Shinozuka Hospital
City
Gunma
ZIP/Postal Code
375-0017
Country
Japan
Facility Name
National Hospital Organization Hiroshima-nishi Medical Ctr.
City
Hiroshima
ZIP/Postal Code
739-0696
Country
Japan
Facility Name
Kobe University Hospital
City
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Nishi-Kobe Medical Center
City
Hyogo
ZIP/Postal Code
651-2273
Country
Japan
Facility Name
Kobe City Hospital Org Kobe City Medical Cente West Hp
City
Hyogo
ZIP/Postal Code
653-0013
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Kagawa University Hospital
City
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Nippon Medical School Musashikosugi Hospital
City
Kanagawa
ZIP/Postal Code
211-8533
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Shonan Atsugi Hospital
City
Kanagawa
ZIP/Postal Code
243-8551
Country
Japan
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto
ZIP/Postal Code
607-8062
Country
Japan
Facility Name
National Hospital Organization Minami-Kyoto Hospital
City
Kyoto
ZIP/Postal Code
610-0113
Country
Japan
Facility Name
National Hospital Organization Maizuru Medical Center
City
Kyoto
ZIP/Postal Code
625-8502
Country
Japan
Facility Name
National Hospital Organization Matsumoto Medical Center
City
Nagano
ZIP/Postal Code
399-0021
Country
Japan
Facility Name
National Hospital Organization Niigata National Hospital
City
Niigata
ZIP/Postal Code
945-8585
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
National Hospital Organization Minami-Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-0304
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Kansai Medical University Takii Hospital
City
Osaka
ZIP/Postal Code
570-8507
Country
Japan
Facility Name
National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder
City
Shizuoka
ZIP/Postal Code
420-8688
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Juntendo Tokyo Koto Geriatric Medical Center
City
Tokyo
ZIP/Postal Code
136-0075
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Tokyo
ZIP/Postal Code
193-0944
Country
Japan
Facility Name
National Hospital Organization Tokyo National Hospital
City
Tokyo
ZIP/Postal Code
204-8585
Country
Japan
Facility Name
Seoul National University Bundang Hospital, Department of Psychiatry
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
KonKuk University Hospital, Department of NeuroPsychiatry
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
OCA Hospital
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Instituto Biomedico de Investigacion A.C
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Jeroen Bosch Ziekenhuis
City
's-Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Kennemer Gasthuis
City
Haarlem
ZIP/Postal Code
2035 RC
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
s. Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
The Memory Clinic
City
Auckland
State/Province
NZ
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Signet Research
City
Christchurch
ZIP/Postal Code
8014
Country
New Zealand
Facility Name
NZOZ Dom Suer Ryder, Pallmed Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
NZOZ "SYNAPSA", ul. Niska 5/1
City
Kielce
ZIP/Postal Code
25-317
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy
City
Poznan
ZIP/Postal Code
61-289
Country
Poland
Facility Name
Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,
City
Warszawa
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Hospital Fernando da Fonseca
City
Amadora
ZIP/Postal Code
2700-276
Country
Portugal
Facility Name
Hospitais Da Universidade De Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-028
Country
Portugal
Facility Name
Interregional clinicodiagnostic center
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Saint-Petersburg State institution of healthcare, City geriatric medico-social center
City
Saint-Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
City
Saint-Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev
City
Saint-Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Chair of nervous system diseases
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Klinicki centar Vojvodine
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Klinicki centar Srbije
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Klinicki centar Srbije
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
1. Neurologicka klinika
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Psychiatricka ambulancia
City
Bratislava
ZIP/Postal Code
820 07
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
825 56
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Neurologicka klinika
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Psychiatricka nemocnica Michalovce, n.o.
City
Michalovce
ZIP/Postal Code
071 01
Country
Slovakia
Facility Name
Vseobecna nemocnica Rimavska Sobota
City
Rimavska Sobota
ZIP/Postal Code
979 12
Country
Slovakia
Facility Name
Neurologicke oddelenie FNsP Zilina
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Boithuso Caregivers
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1709
Country
South Africa
Facility Name
The Osteoporosis and Memory Centre
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Denmar Clinic
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0081
Country
South Africa
Facility Name
St Augustine's Medical Centre 2
City
Durban
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Panorama Psychiatry and Memory Clinic
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Mutua de Terrasa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Virgen del Puerto
City
Plasencia
State/Province
Caceres
ZIP/Postal Code
10600
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
CLONUS
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital de Cruces
City
Baracaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Fundació ACE Institut Catala de Neurociences Aplicades
City
Barcelona
ZIP/Postal Code
08029
Country
Spain
Facility Name
Clínica CIMA
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Divino Valles
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Skanes Universitetssjukhus, Neuropsykiatriska
City
Malmo
ZIP/Postal Code
21 224
Country
Sweden
Facility Name
PET center
City
Uppsala
ZIP/Postal Code
751 09
Country
Sweden
Facility Name
The clinic: Minnes- och geriatrikmottagningen
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
MRI Dept: ORKI
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Memory Clinic Neuro-Psychologie Zentrum
City
Basel
State/Province
BS
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Les Acacias
State/Province
GE
ZIP/Postal Code
1227
Country
Switzerland
Facility Name
CHUV Lausanne
City
Lausanne
State/Province
VD
ZIP/Postal Code
1005
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve
City
Thonex-Geneva
ZIP/Postal Code
CH-1226
Country
Switzerland
Facility Name
MAC UK Neuroscience Ltd
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Facility Name
MAC UK Neuroscience, Ltd.
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD3 0DQ
Country
United Kingdom
Facility Name
Clinical Investigation and Research Unit (CIRU)
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Glasgow Memory Clinic
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Dept. of Neurosciences Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Northampton General Hospital NHS Trust
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Llandough Hospital
City
Penarth
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Grenoside Grange Hospital
City
Sheffield
ZIP/Postal Code
S35 8QS
Country
United Kingdom
Facility Name
Kingshill Research Centre
City
Swindon
ZIP/Postal Code
SN3 6BW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27176461
Citation
Vandenberghe R, Rinne JO, Boada M, Katayama S, Scheltens P, Vellas B, Tuchman M, Gass A, Fiebach JB, Hill D, Lobello K, Li D, McRae T, Lucas P, Evans I, Booth K, Luscan G, Wyman BT, Hua L, Yang L, Brashear HR, Black RS; Bapineuzumab 3000 and 3001 Clinical Study Investigators. Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016 May 12;8(1):18. doi: 10.1186/s13195-016-0189-7.
Results Reference
derived
PubMed Identifier
26297092
Citation
Lacey L, Bobula J, Rudell K, Alvir J, Leibman C. Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Changes Observed. Value Health. 2015 Jul;18(5):638-45. doi: 10.1016/j.jval.2015.03.1787. Epub 2015 Apr 10.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3133K1-3000&StudyName=Study%20Evaluating%20The%20Efficacy%20And%20Safety%20Of%20Bapineuzumab%20In%20Alzheimer%20Disease%20Patients
Description
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Learn more about this trial

Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

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