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: August 1, 2014
Last verified: August 2014
  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: November 2018
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127633

  Hide Study Locations
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: August 1, 2014
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 August 26, 2014