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A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bapineuzumab
Sponsored by
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Mild to moderate Alzheimer's disease

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of probable AD
  • Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
  • Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
  • Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
  • Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)

Sites / Locations

  • University of Alabama Hospital
  • Dedicated Clinical Research, Inc.
  • Banner Alzheimer's Institute
  • HOPE Research Institute, LLC
  • Banner Research Institute
  • University of Arizona College of Medicine, Health Sciences Center
  • Northwest NeuroSpecialists, PLLC
  • Clinical Trials, Inc.
  • East Bay Physicians Medical Group
  • AVI Clinical Research
  • ATP Clinical Research, Inc.
  • Pharmacology Research Institute
  • Margolin Brain Institute
  • Neurology Center of North Orange County
  • Coordinated Clinical Research
  • University of California San Diego
  • Senior Clinical Trials, Inc.
  • Collaborative NeuroScience Network, Inc.
  • Pharmacology Research Institute
  • UCLA Department of Neurology
  • Pharmacology Research Institute
  • Neurology Center
  • University of California, Irvine Medical Center
  • Neuro-Therapeutics, Inc.
  • Sutter Neuroscience Medical Group
  • University of California at Davis, Alzheimer's Disease Research Center
  • Artemis Institute for Clinical Research
  • Sharp Mesa Vista Hospital
  • San Francisco Clinical Research Center
  • University of California San Francisco
  • Neurological Research Institute
  • Schuster Medical Research Institute
  • Diablo Clinical Research, Inc
  • Alpine Clinical Research Center
  • Mile High Research Center
  • Advanced Neurosciences Research, LLC
  • Associated Neurologists, PC
  • Associated Neurologists of Southern Connecticut, P.C.
  • Institute for Neurodegenerative Disorders
  • Yale University School of Medicine
  • Research Center for Clinical Studies, Inc.
  • Chase Medical Research, LLC
  • Christiana Care Neurology Specialists
  • Georgetown University Medical Center
  • JEM Research, LLC
  • Bradenton Research Center, Inc.
  • Quantum Laboratories, Inc.
  • Brain Matters Research
  • Neurologic Consultants, PA
  • Neuropsychiatric Research Center of Southwest Florida
  • Clinical Physiology Associates, Inc
  • Emerald Coast Mood and Memory, PA.
  • MD Clinical
  • Mayo Clinic College of Medicine
  • Neurology Associates
  • Melbourne Internal Medicine Associates
  • Pharmax Research Clinic, LLC
  • Miami Jewish Health Systems
  • Allied Clinical Trials Inc.
  • Miami Research Associates
  • Renstar Medical Research
  • Compass Research, LLC
  • Palm Beach Neurological Center, Advanced Research Consultants, Inc.
  • Neurostudies, Inc.
  • Suncoast Neuroscience Associates, Inc.
  • The Roskamp Institute, Inc
  • Axiom Clinical Research of Florida
  • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
  • Stedman Clinical Trials, LLC
  • University of South Florida Suncoast Alzheimer's and Gerontology Center
  • Premiere Research Institute
  • Emory University, School of Medicine
  • Multiple Sclerosis Center of Atlanta
  • NeuroTrials Research, Inc.
  • Medical Research and Health Education Foundation, Inc.
  • Medical Research and Health Education Foundation, Inc
  • DeKalb Neurology Associates, LLC
  • Gwinnett Medical Center
  • University of Chicago Medical Center
  • Alexian Brothers Neuroscience Institute
  • Methodist Medical Center of Illinois
  • Southern Illinois University School of Medicine
  • Elkhart Clinic, LLC
  • Indiana University School of Medicine
  • The University of Kansas Medical Center
  • MidAmerica Neuroscience Institute
  • Associates in Neurology, PSC
  • University of Kentucky
  • Four Rivers Clinical Research, Inc.
  • Lake Charles Clinical Trials
  • J. Gary Booker, MD, APMC
  • Maine Medical Partners Neurology
  • CBH Health, LLC
  • Brigham and Women's Hospital, Dept. of Neurology
  • Boston University School of Medicine
  • ActivMed Practices and Research, Inc.
  • Neurocare, Inc.
  • Neuroscience Research of the Berkshires
  • Donald S. Marks, MD, PC
  • Springfield Neurology Associates, LLC
  • University of Michigan Medical Center
  • Henry Ford Hospital
  • Michigan State University
  • Borgess Medical Center/Borgess Research Institute
  • Mayo Clinic
  • Hattiesburg Clinic
  • Center for Pharmaceutical Research
  • Saint Louis University School of Medicine
  • Washington University School of Medicine
  • Deaconess Billings Clinical Research Center
  • Advanced Neurology Specialists
  • University of Nebraska Medical Center
  • Memory Enhancement Center of America, Inc.
  • Alzheimer's Research Corporation
  • Global Medical Institutes, LLC
  • Shore Neurology, PA
  • Albuquerque Neuroscience, Inc.
  • Upstate Clinical Research, LLC
  • Neurological Associates of Albany, PC
  • Neuroscience Research Center at Albany Medical Center
  • Advanced BioBehavioral Sciences
  • Empire Neurology, PC
  • Neurological Care of Central New York
  • Parker Jewish Institute for Health Care and Rehabilitation
  • New York University School of Medicine/Psychiarty
  • Columbia University Medical Center
  • Nathan S. Kline Institute for Psychiatric Research
  • University of Rochester Medical Center, Monroe Community Hospital
  • Duke University Medical Center
  • Clinical Trials of America, Inc
  • Raleigh Neurology Associates
  • Neuro-Behavioral Clinical Research, Inc.
  • Ohio State University, Dept. of Neurology
  • Neurology Specialists, Inc.
  • Lynn Health Science Institute
  • Red River Medical Research Center, LLC
  • Providence Medical Group-Medford Neurology
  • Summit Research Group, LLC
  • Providence Health Service System, AD Center, Brain Institute
  • Oregon Health and Science University
  • Abington Neurological Associates, Ltd.
  • Lehigh Valley Health Network
  • The Clinical Trial Center, LLC
  • Drexel University College of Medicine
  • Penn Memory Center
  • Jefferson Hospital for Neuroscience
  • Clinical Trials Research Services, LLC
  • University of Pittsburgh
  • Rhode Island Mood and Memory Research Institute
  • Rhode Island Hospital
  • Butler Hospital
  • Medical University of South Carolina
  • Avera Research Institute
  • Neurology Clinic, P.C.
  • East Tennessee State University
  • Volunteer Research Group
  • Psychiatric Consultants, PC
  • Senior Adults Specialty Research (SASR)
  • Texas Neurology, PA
  • University of Texas Southwestern Medical Center, Dept. of Neurology
  • InSite Clinical Research
  • University of North Texas Health Science Center at Fort Worth
  • Baylor College of Medicine
  • Innovative Clinical Trials
  • Integra Clinical Research, LLC
  • Wasatch Clinical Research
  • University of Utah, Dept. of Neurology
  • The Memory Clinic
  • Fletcher Allen Health Care
  • Innovative Clinical Research Center
  • University of Virginia
  • Alliance Research Group, LLC
  • University of Washington Veterans Affairs
  • Pacific Medical Centers
  • Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital
  • Independent Psychiatric Consultants
  • Landeskrankenhaus- Universitätsklinikum Graz
  • University of Calgary, Foothills Medical Centre
  • Medical Arts Health Research Group
  • Medical Arts Health Research Group
  • Queens University Memorial Clinics
  • Parkwood Hospital
  • Bruyere Continuing Care
  • Neurology Research Inc
  • Toronto Centre for Memory and Aging
  • Ontario Shores Centre for Mental Health Sciences
  • Neuro Rive-Sud Memory Clinic
  • Hôpital Maisonneuve-Rosemont
  • Sir Mortimer B. Davis, Jewish General Hospital
  • Diex Research Sherbrooke Inc.
  • Douglas Mental Health University Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bapineuzumab 0.5 mg/kg

Bapineuzumab 1.0 mg/kg

Arm Description

0.5 mg/kg

1.0 mg/kg

Outcomes

Primary Outcome Measures

Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.

Secondary Outcome Measures

To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.

Full Information

First Posted
July 7, 2009
Last Updated
November 26, 2013
Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00937352
Brief Title
A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
Official Title
A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer's Disease Who Participated in Study ELN115727-301 or Study ELN115727-302.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Mild to moderate Alzheimer's disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bapineuzumab 0.5 mg/kg
Arm Type
Active Comparator
Arm Description
0.5 mg/kg
Arm Title
Bapineuzumab 1.0 mg/kg
Arm Type
Active Comparator
Arm Description
1.0 mg/kg
Intervention Type
Drug
Intervention Name(s)
Bapineuzumab
Intervention Description
0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years. 1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
Primary Outcome Measure Information:
Title
Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.
Time Frame
Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.
Time Frame
The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of probable AD Must have completed study 301 or study 302; and have completed Visit 15 (Week 78) Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71 Caregiver able to attend all clinic visits with patient Exclusion Criteria: Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)
Facility Information:
Facility Name
University of Alabama Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Dedicated Clinical Research, Inc.
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
HOPE Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Banner Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
University of Arizona College of Medicine, Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Northwest NeuroSpecialists, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Clinical Trials, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
East Bay Physicians Medical Group
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
AVI Clinical Research
City
Carson
State/Province
California
ZIP/Postal Code
90746
Country
United States
Facility Name
ATP Clinical Research, Inc.
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
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Coordinated Clinical Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Senior Clinical Trials, Inc.
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
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
UCLA Department of Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Neurology Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Neuro-Therapeutics, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Sutter Neuroscience Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California at Davis, Alzheimer's Disease Research Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Artemis Institute for Clinical Research
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
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Diablo Clinical Research, Inc
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Advanced Neurosciences Research, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
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
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
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
Christiana Care Neurology Specialists
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
JEM Research, LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Bradenton Research Center, Inc.
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Quantum Laboratories, Inc.
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, PA
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Clinical Physiology Associates, Inc
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Emerald Coast Mood and Memory, PA.
City
Fort Walton Beach
State/Province
Florida
ZIP/Postal Code
32547
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Mayo Clinic College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Neurology Associates
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Melbourne Internal Medicine Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Pharmax Research Clinic, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Allied Clinical Trials Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
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, Advanced Research Consultants, Inc.
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
Facility Name
Neurostudies, Inc.
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Suncoast Neuroscience Associates, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
The Roskamp Institute, Inc
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University of South Florida Suncoast Alzheimer's and Gerontology Center
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
Emory University, School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Multiple Sclerosis Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Medical Research and Health Education Foundation, Inc.
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Medical Research and Health Education Foundation, Inc
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
DeKalb Neurology Associates, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gwinnett Medical Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Alexian Brothers Neuroscience Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
Elkhart Clinic, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Associates in Neurology, PSC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Four Rivers Clinical Research, Inc.
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
J. Gary Booker, MD, APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Maine Medical Partners Neurology
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
CBH Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Brigham and Women's Hospital, Dept. of Neurology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University School of Medicine
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, Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Neuroscience Research of the Berkshires
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Donald S. Marks, MD, PC
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
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 Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Borgess Medical Center/Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Saint Louis University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Lous
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Deaconess Billings Clinical Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Advanced Neurology Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
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
Global Medical Institutes, LLC
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Shore Neurology, PA
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Upstate Clinical Research, LLC
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Neurological Associates of Albany, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Neuroscience Research Center at Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Advanced BioBehavioral Sciences
City
Elmsford
State/Province
New York
ZIP/Postal Code
10523
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12110
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
Parker Jewish Institute for Health Care and Rehabilitation
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
New York University School of Medicine/Psychiarty
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Nathan S. Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
University of Rochester Medical Center, Monroe Community Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Clinical Trials of America, Inc
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Ohio State University, Dept. of Neurology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology Specialists, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Red River Medical Research Center, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Providence Medical Group-Medford Neurology
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Summit Research Group, LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Providence Health Service System, AD Center, Brain Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Abington Neurological Associates, Ltd.
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Penn Memory Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Jefferson Hospital for Neuroscience
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
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
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
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
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Neurology Clinic, P.C.
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Psychiatric Consultants, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Senior Adults Specialty Research (SASR)
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Texas Neurology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
University of Texas Southwestern Medical Center, Dept. of Neurology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
University of North Texas Health Science Center at Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76106
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah, Dept. of Neurology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
The Memory Clinic
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Innovative Clinical Research Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Alliance Research Group, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
University of Washington Veterans Affairs
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Pacific Medical Centers
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
Facility Name
Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Independent Psychiatric Consultants
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Landeskrankenhaus- Universitätsklinikum Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Facility Name
University of Calgary, Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Medical Arts Health Research Group
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C 1K7
Country
Canada
Facility Name
Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
Facility Name
Queens University Memorial Clinics
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
Parkwood Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Bruyere Continuing Care
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
Neurology Research Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Toronto Centre for Memory and Aging
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 3Z5
Country
Canada
Facility Name
Ontario Shores Centre for Mental Health Sciences
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1N 5S9
Country
Canada
Facility Name
Neuro Rive-Sud Memory Clinic
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Sir Mortimer B. Davis, Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Douglas Mental Health University Institute
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

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