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Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease (EXPEDITION EXT)

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ClinicalTrials.gov Identifier: NCT01127633
Recruitment Status : Terminated (Solanezumab did not meet the primary endpoint in study H8A-MC-LZAX.)
First Posted : May 21, 2010
Results First Posted : May 3, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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 (NCT00904683).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Solanezumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Solanezumab Drug: Solanezumab
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Other Name: LY2062430

Placebo Comparator: Placebo Drug: Placebo
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.




Primary Outcome Measures :
  1. 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 ]
    The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.


Secondary Outcome Measures :
  1. Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14) [ Time Frame: Baseline, Week 104 ]
    ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean was determined by mixed model repeated measures (MMRM) methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 Mini-Mental State Examination (MMSE) status (mild/moderate), concomitant acetylcholinesterase inhibitors (AChEI)/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  2. 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 ]
    ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  3. Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 104 ]
    CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  4. Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 104 ]
    The NPI is a questionnaire administered to caregivers that quantifies behavioral changes in dementia. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144. Lower scores indicated less severity and higher scores indicated a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  5. Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours [ Time Frame: Baseline, Week 104 ]
    The RUD-Lite is a caregiver-completed assessment designed to assess the amount of formal and informal resources used by participants and the primary caregiver. It is completed by the caregiver and compiles data on the following resources: length of time the caregiver spends giving care, assisting participants with basic activities of daily living (BADL: eating dressing, grooming, bathing); assisting participants with instrumental activities of daily living (IADLs: shopping, cooking, housekeeping, laundry, transportation, taking medication, managing finances), and providing supervision. Scores range from 0 to 24 hours. Higher values indicate greater resource use. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  6. 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 ]
    EQ-5D (proxy version) is a generic, multidimensional, health-related, quality-of-life instrument assessing caregiver's impression of participants overall health state. Profile allows caregivers to rate participant's health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale: 1 (no problem), 2 (some problems), and 3 (major problems). These attribute combinations are converted into a weighted Health-State Index Score according to the United States (US) population-based algorithm. EQ-5D US Population-Based Index Scores range from -0.11 to 1.0. A score of 1.0 indicated perfect health. The Overall Health State Index Score is caregiver-reported using a visual analogue scale marked 0 (worst imaginable health) to 100 (best imaginable health state). LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  7. Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) [ Time Frame: Baseline, Week 104 ]
    The QoL-AD (Caregiver Total Score) is a disease-specific measure of quality of life for an Alzheimer's Disease (AD) population administered to the participant's primary caregiver, who answers on behalf of the participant. The assessment consists of 13 items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The assessment is scored on a 4-point Likert scale with scores ranging from 1 (poor) to 4 (excellent). QoL-AD Total Score is defined as the sum of the 13 items with a scores range from 13 to 52. Higher scores denote a better quality of life. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  8. Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, Week 104 ]
    The MMSE is an instrument used to assess a participant's cognitive function. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention with scores ranging from 0 to 21 (lower scores indicate greater impairment). The second section tests the ability of the participant to name objects, follow verbal and written commands, write a sentence, and copy figures with scores ranging from 0 to 9 (lower scores indicate greater impairment). The range for MMSE Total Score is 0 to 30. Lower scores indicate more impairment. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  9. Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels [ Time Frame: Baseline, Week 52 ]
    Concentration of the peptide Aβ 1-40 and Aβ 1-42 in plasma measured by immunoassay. The immunoassays for plasma Aβ 1-40 and Aβ 1-42 peptides were modified to render them tolerant to the presence of Solanezumab which would otherwise interfere with non-modified assays. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  10. Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, Week 104 ]
    The vMRI assessment of right and left hippocampal volume is reported. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  11. 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 ]
    The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease: orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.

  12. Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease [ Time Frame: Baseline, Week 104 ]
    Florbetapir PET imaging was used to test for change from baseline. The hypothesis that amyloid burden was reduced in participants between the treatment groups from the feeder studies was tested. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum and to subject-specific white matter.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01127633


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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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Tucson, 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 Springs, Florida, United States, 33166
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Miami, Florida, United States, 33137
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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
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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Baggiovara, Italy, 41100
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Biella, Italy, 13900
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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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Jönköping, 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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Guishan, Taiwan, 33305
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Niaosong, 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01127633     History of Changes
Other Study ID Numbers: 11935
H8A-MC-LZAO ( Other Identifier: Eli Lilly and Company )
First Posted: May 21, 2010    Key Record Dates
Results First Posted: May 3, 2018
Last Update Posted: June 5, 2018
Last Verified: May 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.


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