A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
This study has been terminated.
Sponsor:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00937352
First received: July 7, 2009
Last updated: August 24, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Bapineuzumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:
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. [ Time Frame: Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1350 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bapineuzumab 0.5 mg/kg
0.5 mg/kg
|
Drug: Bapineuzumab
Comparison of 0.5 mg/kg to 1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
|
|
Active Comparator: Bapineuzumab 1.0 mg/kg
1.0 mg/kg
|
Drug: Bapineuzumab
Comparison of 0.5 mg/kg to 1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
|
Eligibility| Ages Eligible for Study: | 51 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937352
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| United States, Alabama | |
| University of Alabama Hospital | |
| Birmingham, Alabama, United States, 35205 | |
| United States, Arizona | |
| Dedicated Clinical Research, Inc. | |
| Goodyear, Arizona, United States, 85395 | |
| HOPE Research Institute, LLC | |
| Phoenix, Arizona, United States, 85050 | |
| Banner Alzheimer's Institute | |
| Phoenix, Arizona, United States, 85006 | |
| Banner Research Institute | |
| Sun City, Arizona, United States, 85351 | |
| University of Arizona College of Medicine, Health Sciences Center | |
| Tucson, Arizona, United States, 85724 | |
| Northwest NeuroSpecialists, PLLC | |
| Tucson, Arizona, United States, 85741 | |
| United States, Arkansas | |
| Clinical Trials, Inc. | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| East Bay Physicians Medical Group | |
| Berkeley, California, United States, 94705 | |
| AVI Clinical Research | |
| Carson, California, United States, 90746 | |
| ATP Clinical Research, Inc. | |
| Costa Mesa, California, United States, 92626 | |
| Pharmacology Research Institute | |
| Encino, California, United States, 91316 | |
| Margolin Brain Institute | |
| Fresno, California, United States, 93720 | |
| Neurology Center of North Orange County | |
| Fullerton, California, United States, 92835 | |
| University of California San Diego | |
| La Jolla, California, United States, 92037 | |
| Coordinated Clinical Research | |
| La Jolla, California, United States, 92037 | |
| Senior Clinical Trials, Inc. | |
| Laguna Hills, California, United States, 92653 | |
| Collaborative NeuroScience Network, Inc. | |
| Long Beach, California, United States, 90806 | |
| Pharmacology Research Institute | |
| Los Alamitos, California, United States, 90720 | |
| UCLA Department of Neurology | |
| Los Angeles, California, United States, 90095 | |
| Pharmacology Research Institute | |
| Newport Beach, California, United States, 92660 | |
| Neurology Center | |
| Oceanside, California, United States, 92056 | |
| University of California, Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Neuro-Therapeutics, Inc. | |
| Pasadena, California, United States, 91105 | |
| University of California at Davis, Alzheimer's Disease Research Center | |
| Sacramento, California, United States, 95817 | |
| Sutter Neuroscience Medical Group | |
| Sacramento, California, United States, 95816 | |
| Artemis Institute for Clinical Research | |
| San Diego, California, United States, 92123 | |
| Sharp Mesa Vista Hospital | |
| San Diego, California, United States, 92123 | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
| San Francisco Clinical Research Center | |
| San Francisco, California, United States, 94109 | |
| Neurological Research Institute | |
| Santa Monica, California, United States, 90404 | |
| Schuster Medical Research Institute | |
| Sherman Oaks, California, United States, 91403 | |
| Diablo Clinical Research, Inc | |
| Walnut Creek, California, United States, 94596 | |
| United States, Colorado | |
| Alpine Clinical Research Center | |
| Boulder, Colorado, United States, 80304 | |
| Mile High Research Center | |
| Denver, Colorado, United States, 80218 | |
| Advanced Neurosciences Research, LLC | |
| Fort Collins, Colorado, United States, 80528 | |
| United States, Connecticut | |
| Associated Neurologists, PC | |
| Danbury, Connecticut, United States, 06810 | |
| Associated Neurologists of Southern Connecticut, P.C. | |
| Fairfield, Connecticut, United States, 06824 | |
| Institute for Neurodegenerative Disorders | |
| New Haven, Connecticut, United States, 06510 | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| Research Center for Clinical Studies, Inc. | |
| Norwalk, Connecticut, United States, 06851 | |
| Chase Medical Research, LLC | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Delaware | |
| Christiana Care Neurology Specialists | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20057 | |
| United States, Florida | |
| JEM Research, LLC | |
| Atlantis, Florida, United States, 33462 | |
| Bradenton Research Center, Inc. | |
| Bradenton, Florida, United States, 34205 | |
| Quantum Laboratories, Inc. | |
| Deerfield Beach, Florida, United States, 33064 | |
| Brain Matters Research | |
| Delray Beach, Florida, United States, 33445 | |
| Neurologic Consultants, PA | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Neuropsychiatric Research Center of Southwest Florida | |
| Fort Myers, Florida, United States, 33912 | |
| Clinical Physiology Associates, Inc | |
| Fort Myers, Florida, United States, 33916 | |
| Emerald Coast Mood and Memory, PA. | |
| Fort Walton Beach, Florida, United States, 32547 | |
| MD Clinical | |
| Hallandale Beach, Florida, United States, 33009 | |
| Mayo Clinic College of Medicine | |
| Jacksonville, Florida, United States, 32224 | |
| Neurology Associates | |
| Maitland, Florida, United States, 32751 | |
| Melbourne Internal Medicine Associates | |
| Melbourne, Florida, United States, 32901 | |
| Miami Research Associates | |
| Miami, Florida, United States, 33173 | |
| Allied Clinical Trials Inc. | |
| Miami, Florida, United States, 33156 | |
| Pharmax Research Clinic, LLC | |
| Miami, Florida, United States, 33126 | |
| Miami Jewish Health Systems | |
| Miami, Florida, United States, 33137 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| Compass Research, LLC | |
| Orlando, Florida, United States, 32806 | |
| Palm Beach Neurological Center, Advanced Research Consultants, Inc. | |
| Palm Beach Gardens, Florida, United States, 33418 | |
| Neurostudies, Inc. | |
| Port Charlotte, Florida, United States, 33952 | |
| Suncoast Neuroscience Associates, Inc. | |
| Saint Petersburg, Florida, United States, 33713 | |
| The Roskamp Institute, Inc | |
| Sarasota, Florida, United States, 34243 | |
| Stedman Clinical Trials, LLC | |
| Tampa, Florida, United States, 33613 | |
| Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute | |
| Tampa, Florida, United States, 33613 | |
| University of South Florida Suncoast Alzheimer's and Gerontology Center | |
| Tampa, Florida, United States, 33613 | |
| Axiom Clinical Research of Florida | |
| Tampa, Florida, United States, 33609 | |
| Premiere Research Institute | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Multiple Sclerosis Center of Atlanta | |
| Atlanta, Georgia, United States, 30327 | |
| Emory University, School of Medicine | |
| Atlanta, Georgia, United States, 30322 | |
| NeuroTrials Research, Inc. | |
| Atlanta, Georgia, United States, 30342 | |
| Medical Research and Health Education Foundation, Inc | |
| Columbus, Georgia, United States, 31909 | |
| Medical Research and Health Education Foundation, Inc. | |
| Columbus, Georgia, United States, 31909 | |
| DeKalb Neurology Associates, LLC | |
| Decatur, Georgia, United States, 30033 | |
| Gwinnett Medical Center | |
| Lawrenceville, Georgia, United States, 30045 | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| Alexian Brothers Neuroscience Institute | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61602 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794 | |
| United States, Indiana | |
| Elkhart Clinic, LLC | |
| Elkhart, Indiana, United States, 46514 | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kansas | |
| The University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| MidAmerica Neuroscience Institute | |
| Lenexa, Kansas, United States, 66214 | |
| United States, Kentucky | |
| Associates in Neurology, PSC | |
| Lexington, Kentucky, United States, 40513 | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| Four Rivers Clinical Research, Inc. | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Louisiana | |
| Lake Charles Clinical Trials | |
| Lake Charles, Louisiana, United States, 70629 | |
| J. Gary Booker, MD, APMC | |
| Shreveport, Louisiana, United States, 71104 | |
| United States, Maine | |
| Maine Medical Partners Neurology | |
| Scarborough, Maine, United States, 04074 | |
| United States, Maryland | |
| CBH Health, LLC | |
| Rockville, Maryland, United States, 20850 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital, Dept. of Neurology | |
| Boston, Massachusetts, United States, 02115 | |
| Boston University School of Medicine | |
| Boston, Massachusetts, United States, 02118 | |
| ActivMed Practices and Research, Inc. | |
| Haverhill, Massachusetts, United States, 01830 | |
| Neurocare, Inc. | |
| Newton, Massachusetts, United States, 02459 | |
| Neuroscience Research of the Berkshires | |
| Pittsfield, Massachusetts, United States, 01201 | |
| Donald S. Marks, MD, PC | |
| Plymouth, Massachusetts, United States, 02360 | |
| Springfield Neurology Associates, LLC | |
| Springfield, Massachusetts, United States, 01104 | |
| United States, Michigan | |
| University of Michigan Medical Center | |
| Ann Arbor, Michigan, United States, 48105 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| Michigan State University | |
| East Lansing, Michigan, United States, 48824 | |
| Borgess Medical Center/Borgess Research Institute | |
| Kalamazoo, Michigan, United States, 49048 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| Hattiesburg Clinic | |
| Hattiesburg, Mississippi, United States, 39401 | |
| United States, Missouri | |
| Center for Pharmaceutical Research | |
| Kansas City, Missouri, United States, 64114 | |
| Saint Louis University School of Medicine | |
| Saint Louis, Missouri, United States, 63104 | |
| Washington University School of Medicine | |
| Saint Lous, Missouri, United States, 63108 | |
| United States, Montana | |
| Deaconess Billings Clinical Research Center | |
| Billings, Montana, United States, 59101 | |
| Advanced Neurology Specialists | |
| Great Falls, Montana, United States, 59405 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| Memory Enhancement Center of America, Inc. | |
| Eatontown, New Jersey, United States, 07724 | |
| Alzheimer's Research Corporation | |
| Manchester, New Jersey, United States, 08759 | |
| Global Medical Institutes, LLC | |
| Princeton, New Jersey, United States, 08540 | |
| Shore Neurology, PA | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New Mexico | |
| Albuquerque Neuroscience, Inc. | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Neuroscience Research Center at Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Neurological Associates of Albany, PC | |
| Albany, New York, United States, 12208 | |
| Upstate Clinical Research, LLC | |
| Albany, New York, United States, 12205 | |
| Advanced BioBehavioral Sciences | |
| Elmsford, New York, United States, 10523 | |
| Empire Neurology, PC | |
| Latham, New York, United States, 12110 | |
| Neurological Care of Central New York | |
| Liverpool, New York, United States, 13088 | |
| Parker Jewish Institute for Health Care and Rehabilitation | |
| New Hyde Park, New York, United States, 11040 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| New York University School of Medicine/Psychiarty | |
| New York, New York, United States, 10016 | |
| Nathan S. Kline Institute for Psychiatric Research | |
| Orangeburg, New York, United States, 10962 | |
| University of Rochester Medical Center, Monroe Community Hospital | |
| Rochester, New York, United States, 14620 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Clinical Trials of America, Inc | |
| Hickory, North Carolina, United States, 28601 | |
| Raleigh Neurology Associates | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| Neuro-Behavioral Clinical Research, Inc. | |
| Canton, Ohio, United States, 44718 | |
| Ohio State University, Dept. of Neurology | |
| Columbus, Ohio, United States, 43210 | |
| Neurology Specialists, Inc. | |
| Dayton, Ohio, United States, 45417 | |
| United States, Oklahoma | |
| Lynn Health Science Institute | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Red River Medical Research Center, LLC | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Providence Medical Group-Medford Neurology | |
| Medford, Oregon, United States, 97504 | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| Summit Research Group, LLC | |
| Portland, Oregon, United States, 97223 | |
| Providence Health Service System, AD Center, Brain Institute | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Abington Neurological Associates, Ltd. | |
| Abington, Pennsylvania, United States, 19001 | |
| Lehigh Valley Health Network | |
| Allentown, Pennsylvania, United States, 18103 | |
| The Clinical Trial Center, LLC | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| Jefferson Hospital for Neuroscience | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Penn Memory Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Clinical Trials Research Services, LLC | |
| Pittsburgh, Pennsylvania, United States, 15206 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Rhode Island Mood and Memory Research Institute | |
| East Providence, Rhode Island, United States, 02914 | |
| Butler Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| North Charleston, South Carolina, United States, 29406 | |
| United States, South Dakota | |
| Avera Research Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Tennessee | |
| Neurology Clinic, P.C. | |
| Cordova, Tennessee, United States, 38018 | |
| East Tennessee State University | |
| Johnson City, Tennessee, United States, 37614 | |
| Volunteer Research Group | |
| Knoxville, Tennessee, United States, 37920 | |
| Psychiatric Consultants, PC | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Senior Adults Specialty Research (SASR) | |
| Austin, Texas, United States, 78757 | |
| University of Texas Southwestern Medical Center, Dept. of Neurology | |
| Dallas, Texas, United States, 75390 | |
| Texas Neurology, PA | |
| Dallas, Texas, United States, 75214 | |
| InSite Clinical Research | |
| DeSoto, Texas, United States, 75115 | |
| University of North Texas Health Science Center at Fort Worth | |
| Fort Worth, Texas, United States, 76106 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Innovative Clinical Trials | |
| San Antonio, Texas, United States, 78229 | |
| Integra Clinical Research, LLC | |
| San Antonio, Texas, United States, 78231 | |
| United States, Utah | |
| University of Utah, Dept. of Neurology | |
| Salt Lake City, Utah, United States, 84108 | |
| Wasatch Clinical Research | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Vermont | |
| The Memory Clinic | |
| Bennington, Vermont, United States, 05201 | |
| Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Innovative Clinical Research Center | |
| Alexandria, Virginia, United States, 22304 | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22903 | |
| Alliance Research Group, LLC | |
| Richmond, Virginia, United States, 23230 | |
| United States, Washington | |
| Pacific Medical Centers | |
| Seattle, Washington, United States, 98144 | |
| University of Washington Veterans Affairs | |
| Seattle, Washington, United States, 98108 | |
| United States, Wisconsin | |
| Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Independent Psychiatric Consultants | |
| Waukesha, Wisconsin, United States, 53188 | |
| Austria | |
| Landeskrankenhaus- Universitätsklinikum Graz | |
| Graz, Styria, Austria, 8036 | |
| Canada, Alberta | |
| University of Calgary, Foothills Medical Centre | |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Canada, British Columbia | |
| Medical Arts Health Research Group | |
| Kamloops, British Columbia, Canada, V2C 1K7 | |
| Medical Arts Health Research Group | |
| Kelowna, British Columbia, Canada, V1Y 3G8 | |
| Canada, Ontario | |
| Queens University Memorial Clinics | |
| Kingston, Ontario, Canada, K7L 5G2 | |
| Parkwood Hospital | |
| London, Ontario, Canada, N6C 5J1 | |
| Bruyere Continuing Care | |
| Ottawa, Ontario, Canada, K1N 5C8 | |
| Neurology Research Inc | |
| Toronto, Ontario, Canada, M3B 2S7 | |
| Toronto Centre for Memory and Aging | |
| Toronto, Ontario, Canada, M6M 3Z5 | |
| Ontario Shores Centre for Mental Health Sciences | |
| Whitby, Ontario, Canada, L1N 5S9 | |
| Canada, Quebec | |
| Neuro Rive-Sud Memory Clinic | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| Hôpital Maisonneuve-Rosemont | |
| Montréal, Quebec, Canada, H1T 2M4 | |
| Sir Mortimer B. Davis, Jewish General Hospital | |
| Montréal, Quebec, Canada, H3T 1E2 | |
| Diex Research Sherbrooke Inc. | |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Douglas Mental Health University Institute | |
| Verdun, Quebec, Canada, H4H 1R3 | |
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
More Information
No publications provided
| Responsible Party: | JANSSEN Alzheimer Immunotherapy Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT00937352 History of Changes |
| Other Study ID Numbers: | ELN115727-351 |
| Study First Received: | July 7, 2009 |
| Last Updated: | August 24, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration Canada: Health Canada Austria: Austrian Agency for Health and Food Safety (AGES) Germany: Paul-Ehrlich-Institut (PEI) |
Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:
|
Mild to moderate Alzheimer's disease |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013