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Continued Safety Monitoring of Solanezumab in Alzheimer's Disease (EXPEDITION EXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01127633
First received: May 19, 2010
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00905683).


Condition Intervention Phase
Alzheimer's Disease
Drug: Solanezumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Assess the Number of Participants with One or More Drug-Related Adverse Events (AEs) or any Serious AEs (SAEs) [ Time Frame: Baseline through Week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 104-week endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy version (EQ-5D Proxy) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 52-week endpoint in Plasma Amyloid Beta Levels [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 104-week endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11) [ Time Frame: Baseline, Week 104 ] [ Designated as safety issue: No ]
  • Change from baseline to 80-week endpoint in Amyloid Plaque Burden in the Brain using Positron Emission Tomography (PET) Imaging [ Time Frame: Baseline, Week 80 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1275
Study Start Date: December 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solanezumab Drug: Solanezumab
400 mg administered once every 4 weeks by intravenous infusion (IV) for 100 weeks
Other Name: LY2062430

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
  • Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
  • Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
  • Must have good vein access to administer infusions
  • Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127633

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Locations
United States, Arizona
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Phoenix, Arizona, United States, 85006
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Sun City, Arizona, United States, 85351
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Tuscon, Arizona, United States, 85718
United States, Arkansas
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Little Rock, Arkansas, United States, 72211
United States, California
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Carson, California, United States, 90746
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Laguna Hills, California, United States, 92653
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Lomita, California, United States, 90717
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Los Angeles, California, United States, 90073
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Oxnard, California, United States, 93030
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San Diego, California, United States, 92103
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San Francisco, California, United States, 94109
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Santa Ana, California, United States, 92705
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Santa Monica, California, United States, 90404
United States, Colorado
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Denver, Colorado, United States, 80239
United States, Connecticut
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Fairfield, Connecticut, United States, 06824
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Hamden, Connecticut, United States, 06518
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New Haven, Connecticut, United States, 06510
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Norwalk, Connecticut, United States, 06851
United States, Delaware
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Newark, Delaware, United States, 19713
United States, District of Columbia
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Washington, District of Columbia, United States, 20057
United States, Florida
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Boca Raton, Florida, United States, 33431
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Fort Myers, Florida, United States, 33912
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Hollywood, Florida, United States, 33021
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Miami, Florida, United States, 33137
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Miami Springs, Florida, United States, 33166
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Orange City, Florida, United States, 32763
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Orlando, Florida, United States, 32806
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Sunrise, Florida, United States, 33351
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Tampa, Florida, United States, 33613
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Tampa Bay, Florida, United States, 33613
United States, Georgia
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Atlanta, Georgia, United States, 30341
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Canton, Georgia, United States, 30114
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Decatur, Georgia, United States, 30033
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Kentucky
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Lexington, Kentucky, United States, 40503
United States, Maryland
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Baltimore, Maryland, United States, 21285
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Rockville, Maryland, United States, 20852
United States, Massachusetts
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Belmont, Massachusetts, United States, 02478
United States, Michigan
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Traverse City, Michigan, United States, 49684
United States, Missouri
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Creve Coeur, Missouri, United States, 63141
United States, New Mexico
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Albuquerque, New Mexico, United States, 87109
United States, New York
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Albany, New York, United States, 12205
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Amherst, New York, United States, 14226
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Brooklyn, New York, United States, 11235
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Latham, New York, United States, 12210
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New York, New York, United States, 10032
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Staten Island, New York, United States, 10312
United States, North Carolina
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Raleigh, North Carolina, United States, 27607
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Beachwood, Ohio, United States, 44122
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Toledo, Ohio, United States, 43623
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
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Eugene, Oregon, United States, 97401
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Portland, Oregon, United States, 97210
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
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East Providence, Rhode Island, United States, 02914
United States, South Carolina
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Charleston, South Carolina, United States, 29425
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Greer, South Carolina, United States, 29650
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57105
United States, Utah
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Salt Lake City, Utah, United States, 84108
United States, Vermont
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Bennington, Vermont, United States, 05201
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Burlington, Vermont, United States, 05401
United States, Virginia
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Norfolk, Virginia, United States, 23502
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Roanoke, Virginia, United States, 24018
United States, Washington
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Seattle, Washington, United States, 98108
Argentina
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Buenos Aires, Argentina, CBA 1419
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Ciudad Automona De Buenos Aire, Argentina, C1111AAL
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Cordoba, Argentina, X5004AOA
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Mendoza, Argentina, 5500
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Rosario, Argentina, S2000BZL
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Santa Fe, Argentina, S3000FWO
Australia, New South Wales
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Gosford, New South Wales, Australia, 2250
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Kogarah, New South Wales, Australia, 2217
Australia, Queensland
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Chermside, Queensland, Australia, 4032
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Toowoomba, Queensland, Australia, 4650
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Glen Iris, Victoria, Australia, 3146
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Heidelberg Heights, Victoria, Australia, 3081
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Melbourne, Victoria, Australia, 3004
Australia, Western Australia
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Subiaco, Western Australia, Australia, 6008
Brazil
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Curitiba, Brazil, 80060-900
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Itapira, Brazil, 13970-905
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Porto Alegre, Brazil, 90110-270
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Rio De Janeiro, Brazil, 22271-100
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São Paulo, Brazil, 04024-002
Canada, Alberta
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Medicine Hat, Alberta, Canada, T1B4E7
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y3G5
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Penticton, British Columbia, Canada, V2A 5C8
Canada, Ontario
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Ottawa, Ontario, Canada, K1N 5C8
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Toronto, Ontario, Canada, M6M 3Z5
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2J2
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Sherbrooke, Quebec, Canada, J1H1Z1
France
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Paris, France, 75475
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Rennes, France, 35000
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Strasbourg, France, 67091
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Toulouse, France, 31300
Germany
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Berlin, Germany, 12203
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Hamburg, Germany, 22307
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Hannover, Germany, 30559
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Mannheim, Germany, 68165
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Munich, Germany, D-81675
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Regensburg, Germany, 93042
Italy
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Biella, Italy, 13900
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Boggiovara, Italy, 41100
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Chieti, Italy, 66013
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Genova, Italy, 16128
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Lido Di Camaiore, Italy, 55043
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Milano, Italy, 20132
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Rome, Italy, 00186
Japan
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Aichi, Japan, 474-8511
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Ehime, Japan, 791-0295
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Fukuoka, Japan, 816-0864
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Hiroshima, Japan, 720-0825
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Hyogo, Japan, 514-8507
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Kanagawa, Japan, 247-8533
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Kyoto, Japan, 607-8062
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Osaka, Japan, 545-8586
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Shizuoka, Japan, 424-0911
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Tokyo, Japan, 187-8551
Korea, Republic of
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Incheon, Korea, Republic of, 400-711
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Seongnam-Si, Korea, Republic of, 463-707
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Seoul, Korea, Republic of, 143-729
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Suwon-Si, Korea, Republic of, 443-721
Poland
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Bydgoszcz, Poland, 85-796
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Gliwice, Poland, 44-100
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Katowice, Poland, 40-588
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Krakow, Poland, 31-530
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Lublin, Poland, 20-954
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Warsaw, Poland, 01-211
Russian Federation
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Chelyabinsk, Russian Federation, 454091
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Saint Petersburg, Russian Federation, 190021
Spain
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Barcelona, Spain, 08014
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Getafe, Spain, 28905
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Madrid, Spain, 28006
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Plasencia, Spain, 10600
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Terrassa, Spain, 08221
Sweden
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Joenkoeping, Sweden, 551 85
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Kalmar, Sweden, 39185
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Lund, Sweden, 22241
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Molndal, Sweden, 43135
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Umea, Sweden, 901 85
Taiwan
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Kuei Shan Hsiang, Taiwan, 33305
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Niao Sung Hsiang, Taiwan, 833
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Taipei, Taiwan, 112
United Kingdom
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Uckfield, E Susx, United Kingdom, TN225AW
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Scotland, Glasgow, United Kingdom, G20 0XA
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London, Greater London, United Kingdom, N195NX
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Camberwell, London, United Kingdom, SE5 8AF
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01127633     History of Changes
Other Study ID Numbers: 11935, H8A-MC-LZAO
Study First Received: May 19, 2010
Last Updated: December 11, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Japan: Institutional Review Board
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Korea: Institutional Review Board
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Institutional Review Board
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Sweden: Swedish National Council on Medical Ethics
Taiwan: Center for Drug Evaluation
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

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 April 15, 2014