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An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease (AMARANTH)

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ClinicalTrials.gov Identifier: NCT02245737
Recruitment Status : Recruiting
First Posted : September 22, 2014
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that lanabecestat is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2 lanabecestat treatment groups compared with placebo.

Condition or disease Intervention/treatment Phase
Alzheimer´s Disease Drug: Lanabecestat Drug: Placebo Phase 2 Phase 3

Detailed Description:
Participants who meet other study entry requirements will be required to undergo either an amyloid positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid (CSF) sampling at screening to document presence of abnormal levels of brain and CSF amyloid for study inclusion. The study includes 2 sub-studies: the participants that undergo a PET scan at screening will be included in the PET-substudy, and participants who undergo a lumbar puncture at screening will be included in the CSF substudy until each of these substudies are completed.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)
Actual Study Start Date : September 30, 2014
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lanabecestat 20 mg
Lanabecestat 20 milligrams (mg) given orally once daily for 104 weeks.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Experimental: Lanabecestat 50 mg
Lanabecestat 50 mg given orally once daily for 104 weeks.
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
  • AZD3293

Placebo Comparator: Placebo
Placebo given orally once daily for 104 weeks.
Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Change from Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [ Time Frame: Baseline, Week 104 ]

Secondary Outcome Measures :
  1. Change from Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-iADL) Instrumental Items [ Time Frame: Baseline, Week 104 ]
  2. Change from Baseline on the Functional Activities Questionnaire (FAQ) Score [ Time Frame: Baseline, Week 104 ]
  3. Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, Week 104 ]
  4. Change from Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 104 ]
  5. Time in Clinical Dementia Rating (CDR) Global Score Stage [ Time Frame: Baseline through Loss of 1 Global Stage or Week 104 ]
  6. Change from Baseline in Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, Week 104 ]
  7. Change from Baseline on the Mini-Mental Status Examination (MMSE) [ Time Frame: Baseline, Week 104 ]
  8. Pharmacodynamics (PD): Change from Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Aβ1-42 [ Time Frame: Baseline, Week 97 ]
  9. PD: Change from Baseline in Concentration of CSF Biomarker Aβ1-40 [ Time Frame: Baseline, Week 97 ]
  10. Change from Baseline in CSF Total Tau [ Time Frame: Baseline, Week 104 ]
  11. Change from Baseline in CSF Phosphorylated Tau [ Time Frame: Baseline, Week 104 ]
  12. Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) [ Time Frame: Baseline, Week 104 ]
  13. Change From Baseline in Tau PET [ Time Frame: Baseline, Week 104 ]
  14. Change From Baseline in PET Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) [ Time Frame: Baseline, Week 104 ]
  15. Change from Baseline in Whole Brain Volume [ Time Frame: Baseline, Week 104 ]
  16. Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat [ Time Frame: Week 4 through Week 91 ]
  17. Population PK: Central Volume of Distribution of Lanabecestat [ Time Frame: Week 4 through Week 91 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gradual and progressive change in the participant's memory function over more than 6 months, reported by participant and study partner
  • Mini-Mental State Examination score of 20-30 inclusive at screening
  • Objective impairment in memory as evaluated by memory test performed at screening
  • For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD
  • For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD

Exclusion Criteria:

  • Significant neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson´s disease, or epilepsy or recurrent seizures
  • History of clinically evident stroke, or multiple strokes based on history or imaging results
  • History of clinically important carotid or vertebrobasilar stenosis or plaque
  • History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
  • Participants with a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of Major Depressive Disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study
  • History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening
  • Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
  • Congenital QT prolongation
  • History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer or other cancers with low-risk of recurrence or spread
  • Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245737


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute Active, not recruiting
Phoenix, Arizona, United States, 85006
St Josephs Hospital and Medical Center Active, not recruiting
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Institute Active, not recruiting
Sun City, Arizona, United States, 85351
Territory Neurology & Research Institute Active, not recruiting
Tucson, Arizona, United States, 85704
United States, California
Positron Research International Completed
Fremont, California, United States, 94538
Alliance Research Centers Active, not recruiting
Laguna Hills, California, United States, 92653
Senior Clinical Trials, Inc. Active, not recruiting
Laguna Hills, California, United States, 92653
Collaborative Neuroscience Network - CNS Active, not recruiting
Long Beach, California, United States, 90806
Pacific Research Network Inc Active, not recruiting
San Diego, California, United States, 92103
San Francisco Clinical Research Center Completed
San Francisco, California, United States, 94109
United States, Colorado
Mile High Research Center Active, not recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Institute for Neurodegenerative Disorders Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Brain Matters Research Active, not recruiting
Delray Beach, Florida, United States, 33445
Direct Helpers Medical Center Completed
Hialeah, Florida, United States, 33012
Berma Research Completed
Hialeah, Florida, United States, 33016
Galiz Research Active, not recruiting
Hialeah, Florida, United States, 33016
MaxBlue Institute Completed
Hialeah, Florida, United States, 33018
Alzheimer's Research and Treatment Center Active, not recruiting
Lake Worth, Florida, United States, 33449
Miami Jewish Health Systems Active, not recruiting
Miami, Florida, United States, 33137
Medical Research Center Completed
Miami, Florida, United States, 33144
Allied Biomedical Research Institute, Inc. Completed
Miami, Florida, United States, 33155
Advance Medical Research Institute Completed
Miami, Florida, United States, 33174
New Horizon Research Center Completed
Miami, Florida, United States, 33175
JDH Medical Group, LLC Completed
Miami, Florida, United States, 33186
Compass Research Active, not recruiting
Orlando, Florida, United States, 32806
IMIC, Inc. Completed
Palmetto Bay, Florida, United States, 33157
Suncoast Neuroscience Associates Completed
Saint Petersburg, Florida, United States, 33713
Roskamp Institute Active, not recruiting
Sarasota, Florida, United States, 34243
Infinity Clinical Research, LLC Active, not recruiting
Sunrise, Florida, United States, 33351
Stedman Clinical Trials Completed
Tampa, Florida, United States, 33613
Olympian Clinical Research Completed
Tampa, Florida, United States, 33614
Compass Research Active, not recruiting
The Villages, Florida, United States, 32162
Premiere Research Institute at Palm Beach Neurology Active, not recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
The Multiple Sclerosis Center of Atlanta Active, not recruiting
Atlanta, Georgia, United States, 30327
Atlanta Center of Medical Research Active, not recruiting
Atlanta, Georgia, United States, 30331
Carman Research Completed
Smyrna, Georgia, United States, 30080
United States, Illinois
University of Chicago Medical Center Active, not recruiting
Chicago, Illinois, United States, 60637
Alexian Brothers Medical Center Active, not recruiting
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Community Clinical Research Center Active, not recruiting
Anderson, Indiana, United States, 46011
Indiana University School of Medicine Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
ActivMed Practices & Research, Inc Active, not recruiting
Methuen, Massachusetts, United States, 01844
Boston Center for Memory Active, not recruiting
Newton, Massachusetts, United States, 02459
Springfield Neurology Associates Completed
Springfield, Massachusetts, United States, 01104
United States, Mississippi
Hattiesburg Clinic Active, not recruiting
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Millennium Psychiatric Associates, LLV Completed
Saint Louis, Missouri, United States, 63141
St. Louis Clinical Trials, LC Completed
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Memory Enhancement Center of America, Inc. Active, not recruiting
Eatontown, New Jersey, United States, 07724
AdvanceMed Research Completed
Lawrenceville, New Jersey, United States, 08648
Alzheimer's Research Company Active, not recruiting
Manchester, New Jersey, United States, 08759
The Cognitive and Research Center of NJ Active, not recruiting
Springfield, New Jersey, United States, 07081
Advanced Memory Research Institute of New Jersey Completed
Toms River, New Jersey, United States, 08755
Bio Behavioral Health Completed
Toms River, New Jersey, United States, 08755
Neurology Specialists of Monmouth County Active, not recruiting
West Long Branch, New Jersey, United States, 07764
United States, New York
Integrative Clinical Trials, LLC Active, not recruiting
Brooklyn, New York, United States, 11229
SPRI Clinical Trials, LLC. Recruiting
Brooklyn, New York, United States, 11235
Contact    718-616-2250      
Principal Investigator: Evgeny Fink         
Alzheimer's Disease and Memory Disorders Center Active, not recruiting
Buffalo, New York, United States, 14203
Empire Neurology, PC Active, not recruiting
Latham, New York, United States, 12110
Clinilabs, Inc (New York) Completed
New York, New York, United States, 10019
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
University of Rochester Active, not recruiting
Rochester, New York, United States, 14620
United States, North Carolina
Alzheimer's Memory Center Active, not recruiting
Charlotte, North Carolina, United States, 28270
United States, Ohio
Valley Medical Primary Care Active, not recruiting
Centerville, Ohio, United States, 45459
Christ Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45219
Ohio State University Medical Center Active, not recruiting
Columbus, Ohio, United States, 43221
United States, Oregon
The Corvallis Clinic P.C. Active, not recruiting
Corvallis, Oregon, United States, 97330
United States, Pennsylvania
Lehigh Valley Hospital Active, not recruiting
Allentown, Pennsylvania, United States, 18103
United States, Rhode Island
Rhode Island Mood & Memory Research Institute Active, not recruiting
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Roper St. Francis Healthcare Active, not recruiting
Charleston, South Carolina, United States, 29401
Radiant Research Active, not recruiting
Greer, South Carolina, United States, 29651
United States, Tennessee
Quillen College of Medicine, East TN State University Active, not recruiting
Johnson City, Tennessee, United States, 37605
United States, Texas
Senior Adults Specialty Research Inc Completed
Austin, Texas, United States, 78757
Texas Health Physicians Group Completed
Dallas, Texas, United States, 75231
Medical Group of Texas Completed
Fort Worth, Texas, United States, 76104
University of Texas Health Services Center - Houston Active, not recruiting
Houston, Texas, United States, 77054
United States, Utah
University of Utah School of Medicine Active, not recruiting
Salt Lake City, Utah, United States, 84108
United States, Vermont
The Memory Clinic Active, not recruiting
Bennington, Vermont, United States, 05201
Australia, New South Wales
Southern Neurology Active, not recruiting
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Griffith University Active, not recruiting
Goldcoast, Queensland, Australia, 4222
Australia, South Australia
Royal Adelaide Hospital Active, not recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Box Hill Hospital Active, not recruiting
Box Hill, Victoria, Australia, 3128
Delmont Private Hospital Completed
Glen Iris, Victoria, Australia, 3146
Heidelberg Repatriation Hospital Completed
Heidelberg, Victoria, Australia, 3081
The Florey Institute of Neuroscience and Mental Health Active, not recruiting
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Australian Alzheimer's Research Foundation Completed
Nedlands, Western Australia, Australia, 6009
Australia
Neuro Trials Victoria Pty Ltd Active, not recruiting
Noble Park, Australia, 3174
Belgium
Jessa Ziekenhuis Active, not recruiting
Hasselt, Limburg, Belgium, 3500
Hopital Universitaire Brugmann Brussel Active, not recruiting
Brussels, Belgium, 1020
Cliniques Universitaires Saint-Luc Active, not recruiting
Brussels, Belgium, 1200
Hospital Universitaire Erasme Brussel Active, not recruiting
Brussel, Belgium, 1070
Universitair Ziekenhuis Antwerpen Active, not recruiting
Edegem, Belgium, 2650
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Active, not recruiting
Leuven, Belgium, 3000
Heilig Hartziekenhuis Active, not recruiting
Roeselare, Belgium, 8800
Canada, British Columbia
The Medical Arts Health Research Group Completed
Kamloops, British Columbia, Canada, V2C 1K7
Okanagan Clinical Trials Active, not recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
University of British Columbia Active, not recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Royal Jubilee Hospital Active, not recruiting
Victoria, British Columbia, Canada, V8R 158
Canada, Nova Scotia
True North Clinical Research Halifax, LLC Active, not recruiting
Halifax, Nova Scotia, Canada, B3S1M7
Canada, Ontario
Bruyere Continuing Care Active, not recruiting
Ottawa, Ontario, Canada, K1N 5C8
Kawartha Regional Memory Clinic Active, not recruiting
Peterborough, Ontario, Canada, K9H2P4
Toronto Memory Program Active, not recruiting
Toronto, Ontario, Canada, M3B2S7
Toronto Western Hospital Active, not recruiting
Toronto, Ontario, Canada, M5T2S8
Canada, Qubec
CSSS-Institut Universitaire Gériatric de Sherbrooke Active, not recruiting
Sherbrooke, Qubec, Canada, J1J3H5
Canada, Quebec
Clinique de la Memoire de l'Outaouais Active, not recruiting
Gatineau, Quebec, Canada, J8T 8J1
NeuroSearch Developements Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Hopital Maisonneure-Rosemount Completed
Montreal, Quebec, Canada, H1T 2M4
Hopital de L'Enfant Jesus Active, not recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Q&T Research Sherbrooke Inc Active, not recruiting
Sherbrooke, Quebec, Canada, J1J 2G2
France
CHU de Toulouse Hopital Purpan Active, not recruiting
Toulouse, Cedex 9, France, 31059
Hopital Neuro Pierre Wertheimer Active, not recruiting
Bron Cedex, France, 69677
Chu de Nantes Hopital Laennec Active, not recruiting
Cedex 1, France, 44093
CHU Dijonon Active, not recruiting
Dijon Cedex, France, 21033
CHRU Lille - Hopital Roger Salengro Active, not recruiting
Lille Cedex, France, 59037
CHU Hopital de la Timone Active, not recruiting
Marseille Cedex 05, France, 13385
Hopital Broca Active, not recruiting
Paris, France, 75013
Hopital de la Pitie Salpetriere Active, not recruiting
Paris, France, 75013
Hopital Lariboisière Active, not recruiting
Paris, France, 75475
CHU de Toulouse Active, not recruiting
Toulouse, France, 31052
Hopital des Charpennes Active, not recruiting
Villeurbanne, France, 69100
Germany
Universitätsklinikum Tübingen Active, not recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Universitätsklinikum Ulm Active, not recruiting
Ulm, Baden-Württemberg, Germany, 89081
Studien und Gedächtniszentrum München Active, not recruiting
München, Bayern, Germany, 80331
Klinikum Rechts der Isar der TU München Active, not recruiting
München, Bayern, Germany, 81675
Institut fur Psychogerontologie Active, not recruiting
Nürnberg, Bayern, Germany, 90402
Neurozentrum Prien Active, not recruiting
Prien am Chiemsee, Bayern, Germany, 83209
Institut für Neuropsychiatrie INP3 Active, not recruiting
Wenzenbach, Bayern, Germany, 93173
Studienzentrum Nord-West Active, not recruiting
Westerstede, Niedersachsen, Germany, 26655
Praxis Dr. Lauter Completed
Bochum, Nordrhein-Westfalen, Germany, 44787
St Josef-Hospital Bochum Active, not recruiting
Bochum, Nordrhein-Westfalen, Germany, 44791
Universitätsklinikum Bonn Active, not recruiting
Bonn, Nordrhein-Westfalen, Germany, 53105
Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles Active, not recruiting
Köln, Nordrhein-Westfalen, Germany, 50935
Universitätsklinikum Köln Active, not recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Neurologische Praxis Siegen Active, not recruiting
Siegen, Nordrhein-Westfalen, Germany, 57076
Universitätsklinikum des Saarlandes Completed
Homburg, Saarland, Germany, 66421
Martin-Luther-Universität Halle-Wittenberg Completed
Halle (Saale), Sachsen-Anhalt, Germany, 06097
Universitätsklinikum Otto-von-Guericke-Universität Active, not recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Pharmakologisches Studienzentrum Chemnitz Active, not recruiting
Mittweida, Sachsen, Germany, 09648
Arztpraxis Dr. Christian Oehlwein Active, not recruiting
Gera, Thüringen, Germany, 07551
Gemeinschaftspraxis Dr. R. Ehret & Dr. W. von Pannwitz Completed
Berlin, Germany, 12163
Charité Universitätsmedizin Berlin Active, not recruiting
Berlin, Germany, 12203
Charité Universitätsmedizin Berlin Completed
Berlin, Germany, 13353
Hungary
PTE KK Pszichiatriai es Pszichoterapias Klinika Active, not recruiting
Pecs, Baranya, Hungary, 7623
Semmelweis Medical University Active, not recruiting
Budapest, Hungary, 1083
Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet Active, not recruiting
Budapest, Hungary, 1097
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz Active, not recruiting
Debrecen, Hungary, 4031
Debreceni Egyetem Klinikai Kozpont Completed
Debrecen, Hungary, 4032
Univerisity of Szeged Active, not recruiting
Szeged, Hungary, 6725
Italy
Ospedale Degli Infermi ASR USSL 12 Active, not recruiting
Ponderano (BI), Biella, Italy, 13875
Azienda Ospedaliera San Gerardo Active, not recruiting
Monza, Milano, Italy, 20900
Fondazione San Raffaele Giglio di Cefalu Completed
Cefalu, Palermo, Italy, 90015
Universita Di Pisa Active, not recruiting
Pisa, PI, Italy, 56126
Università Politecnica delle Marche Torrette Active, not recruiting
Ancona, Italy, 60126
IRCCS San Giovanni di Dio Fatebenefratelli Active, not recruiting
Brescia, Italy, 25125
Fondazione Universitaria degli Studi G D'Annunzio Active, not recruiting
Chieti, Italy, 66100
Ente Ospedaliero Ospedali Galliera Active, not recruiting
Genova, Italy, 16132
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico Active, not recruiting
Milano, Italy, 20122
Nuovo Ospedale Civile Sant'Agostino Estense Active, not recruiting
Modena, Italy, 41010
Policlinico Univ. Agostino Gemelli Active, not recruiting
Roma, Italy, 00168
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza Active, not recruiting
Roma, Italy, 00185
Ospedale San Giovanni Calibita Fatebenefratelli Active, not recruiting
Roma, Italy, 00186
Policlinico Ospedale S. Andrea Active, not recruiting
Roma, Italy, 00189
Azienda Ospedaliera Citta della Salute della Scienza Torino Active, not recruiting
Torino, Italy, 10126
Japan
National Institute for Longevity Sciences NCGG Active, not recruiting
Obu, Aichi, Japan, 474-0038
National Chiba-East-Hospital Completed
Chuo-ku, Chiba, Japan, 260-8712
National Hospital Organization Asahikawa Medical Center Completed
Asahikawa, Hokkaido, Japan, 070-8644
Tsukuba University Hospital Active, not recruiting
Tsukuba, Ibaraki, Japan, 305-8576
Iwate Medical University Hospital Active, not recruiting
Morioka, Iwate, Japan, 020-8505
Shonan Kamakura General Hospital Active, not recruiting
Kamakura, Kanagawa, Japan, 247-8533
Nihon Kokan Hospital Active, not recruiting
Kawasaki, Kanagawa, Japan, 210-0852
Yokohama City University Hospital Active, not recruiting
Yokohama, Kanagawa, Japan, 236-0004
Kyoto Prefectural University of Medicine Active, not recruiting
Kyoto-shi, Kyoto, Japan, 602-8566
Rakuwakai Otowarehabilitation Hospital Completed
Kyoto-shi, Kyoto, Japan, 607-8113
Ina Central Hospital Active, not recruiting
Ina, Nagano, Japan, 396-8555
Matsumoto Medical Center Active, not recruiting
Matsumoto, Nagano, Japan, 399-0021
Katayama Medical Clinic Active, not recruiting
Kurashiki, Okayama, Japan, 701-0192
Shiroma Clinic Active, not recruiting
Urasoe, Okinawa, Japan, 901-2102
Koshokai aino hospital Active, not recruiting
Ibaragi, Osaka, Japan, 567-0011
Sakaguchi Clinic Active, not recruiting
Sakai, Osaka, Japan, 593-8301
National Sanatorium Toneyama Hospital Active, not recruiting
Toyonaka, Osaka, Japan, 560-8552
Saitama Medical University Hospital Active, not recruiting
Iruma-Gun, Saitama, Japan, 350-0495
Nippon Medical School Hospital Active, not recruiting
Bunkyo-Ku, Tokyo, Japan, 113-8603
The University of Tokyo Hospital Active, not recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Nozomi Memory Clinic Active, not recruiting
Mitaka-shi, Tokyo, Japan, 181-0013
Sangenjaya Nakamura Mental Clinic Active, not recruiting
Setagaya, Tokyo, Japan, 154-0004
Kanauchi Medical Clinic Completed
Shinjuku-ku, Tokyo, Japan, 160-0023
Tokyo Women's Medical University Hospital Active, not recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
Memory Clinic Ochanomizu Active, not recruiting
Tsukuba, Tokyo, Japan, 305 8576
National Sanatorium Hokuriku Hospital Completed
Nanto, Toyama, Japan, 939-1893
Fukuoka University Hospital Completed
Fukuoka, Japan, 814-0180
Kyoto University Hospital Active, not recruiting
Kyoto, Japan, 606-8507
Kyoto Minami Hospital Completed
Kyoto, Japan, 610-0113
Utano Hospital Active, not recruiting
Kyoto, Japan, 616-8255
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Osaka, Japan, 545-8586
Contact: Eli Lilly and Company         
Korea, Republic of
Dong-A University Medical Center Completed
Seo-gu, Busan, Korea, Republic of, 49201
Seoul National University Bundang Hospital Completed
Seongnam-si, Geonggi-do, Korea, Republic of, 13620
The Catholic University of Korea-Bucheon St. Mary's Hospital Completed
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
Hanyang University Guri Hospital Active, not recruiting
Guri-si, Gyeonggido, Korea, Republic of, 11923
Gachon University Gil Medical Center Active, not recruiting
Namdong-gu, Incheon, Korea, Republic of, 21565
Asan Medical Center Active, not recruiting
Songpa-gu, Seoul, Korea, Republic of, 05505
Inha University Hospital Active, not recruiting
Incheon, Korea, Republic of, 22332
Samsung Medical Center Completed
Seoul, Korea, Republic of, 06351
Seoul St. Mary's Hospital Active, not recruiting
Seoul, Korea, Republic of, 06591
Poland
NZOZ Wroclawskie Centrum Alzheimerowskie Active, not recruiting
Wroclaw, Dolnoslaskie, Poland, 53 139
Medycyna Milorzab Active, not recruiting
Lodz, Lódzkie, Poland, 92216
Podlaskie Centrum Psychogeriatrii Active, not recruiting
Białystok, Podlaskie, Poland, 15-732
NZOZ Dom Sue Ryder - Pallmed Sp. z o.o. Active, not recruiting
Bydgoszcz, Poland, 85-796
NZOZ Wielospecjalistyczna Poradnia Lekarska Active, not recruiting
Katowice, Poland, 40-123
Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala Active, not recruiting
Katowice, Poland, 40-588
Centrum Zdrowia Psychicznego Active, not recruiting
Kielce, Poland, 25411
Centrum Neurologii Klinicznej Active, not recruiting
Krakow, Poland, 31-505
NZOZ Neuromed M. I M. Nastaj sp. P. Completed
Lublin, Poland, 20-064
Instytut Medycyny Wsi Active, not recruiting
Lublin, Poland, 20-090
NEURO-CARE Sp. z o.o. Sp. Komandytowa Active, not recruiting
Siemianowice Śląskie, Poland, 41-100
Centrum Medyczne Active, not recruiting
Warszawa, Poland, 01-697
Centralny Szpital Kliniczny MSW Active, not recruiting
Warszawa, Poland, 02-507
Puerto Rico
Santa Cruz Behavioral PSC Active, not recruiting
Bayamon, Puerto Rico, 00961
Ivonne Z. Jimenez-Velazquez, MD Active, not recruiting
Carolina, Puerto Rico, 00984
Instituto de Neurologia Dra. Ivonne Fraga Active, not recruiting
San Juan, Puerto Rico, 00918
Michel A. Woodbury-Farina, MD. Active, not recruiting
San Juan, Puerto Rico, 00918
Romania
SC Med Life SA Active, not recruiting
Bucuresti, Romania, 010719
SC Centrul Medical Sana SRL Active, not recruiting
Bucuresti, Romania, 011025
Policlinica CCBR S.R.L. Completed
Bucuresti, Romania, 30463
SC Med Life SA Completed
Timisoara, Romania, 300166
Spain
Hospital General Universitario de Elche Active, not recruiting
Elche, Alicante, Spain, 03203
Hospital General de Catalunya Active, not recruiting
Sant Cugat del Valles, Barcelona, Spain, 08190
Hospital Virgen Del Puerto Active, not recruiting
Plasencia, Caceres, Spain, 10600
Hospital Universitario De Getafe Active, not recruiting
Madrid, Getafe, Spain, 28905
Hospital Puerta De Hierro Active, not recruiting
Majadahonda, Madrid, Spain, 28222
Centro de Atencion Especializada (CAE) OROITU Completed
Getxo, Vizcaya, Spain, 48993
Hospital del Mar Active, not recruiting
Barcelona, Spain, 08003
Hospital Santa Creu I Sant Pau Active, not recruiting
Barcelona, Spain, 08025
Fundacion ACE-Institut Catala de Neurociences Aplicades Active, not recruiting
Barcelona, Spain, 08028
Hospital Clinic de Barcelona Active, not recruiting
Barcelona, Spain, 08036
Hospital Universitari de Bellvitge Completed
Barcelona, Spain, 08907
Hospital Reina Sofia Active, not recruiting
Cordoba, Spain, 14004
Hospital De La Princesa Active, not recruiting
Madrid, Spain, 28006
Hospital Universitario Ramon y Cajal Active, not recruiting
Madrid, Spain, 28034
Hospital Son Espases Active, not recruiting
Palma de Mallorca, Spain, 07010
Hospital Univ Sant Joan de Reus, S.A. Active, not recruiting
Reus, Spain, 43204
Fundacion CITA Alzheimer Active, not recruiting
San Sebastian, Spain, 20009
Hospital Doctor Peset Active, not recruiting
Valencia, Spain, 46017
Hospital Universitario La Fe de Valencia Completed
Valencia, Spain, 46026
United Kingdom
Plymouth Hospitals NHS Trust Active, not recruiting
Plymouth, Devon, United Kingdom, PL6 8BX
Cognitive Treatment & Research Unit Active, not recruiting
Crowborough, East Sussex, United Kingdom, TN6 1HB
Glasgow Memory Clinic Active, not recruiting
Scotland, Glasgow, United Kingdom, G20 0XA
Southern Health NHS Completed
Southampton, Hampshire, United Kingdom, SO30 3JB
MAC UK Neuroscience Ltd Active, not recruiting
Lancashire, Lancs, United Kingdom, FY20JH
MAC Clinical Research Active, not recruiting
Stourton, Leeds, United Kingdom, LS10 1DU
Re-Cognition Health Ltd Active, not recruiting
Greater London, London, United Kingdom, W1G 9RU
MAC Clinical Research Active, not recruiting
Cannock, Staffordshire, United Kingdom, WS11 0BN
West London Mental Health NHS Trust Active, not recruiting
Brentford, United Kingdom, TW8 8DS
Hammersmith Hospital Active, not recruiting
London, United Kingdom, W12 0NN
Guildford Nuffield Hospital Active, not recruiting
London, United Kingdom, W1G 9JF
MAC Clinical Research Active, not recruiting
Manchester, United Kingdom, M13 9NQ
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02245737     History of Changes
Other Study ID Numbers: 16023
I8D-MC-AZES ( Other Identifier: Eli Lilly and Company )
2014-002601-38 ( EudraCT Number )
D5010C00009 ( Other Identifier: AstraZeneca )
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 17, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
Alzheimer's disease
Dementia
Brain Diseases
Neurogenerative Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Tauopathies

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders