Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease
NCT ID: NCT01127633
Last Updated: 2019-10-08
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
1457 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-12-31
Study Completion Date
2017-02-28
Brief Summary
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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).
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Detailed Description
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Conditions
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Alzheimer's Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Solanezumab
Group Type
EXPERIMENTAL
Solanezumab
Intervention Type
DRUG
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
Interventions
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Solanezumab
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
Intervention Type
DRUG
Placebo
Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
Intervention Type
DRUG
Other Intervention Names
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LY2062430
Eligibility Criteria
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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
* 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
* Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study
Minimum Eligible Age
55 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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Santa Fe, , Argentina
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Gosford, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Chermside, Queensland, Australia
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Toowoomba, Queensland, Australia
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Box Hill, Victoria, Australia
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Glen Iris, Victoria, Australia
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Heidelberg Heights, Victoria, Australia
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Melbourne, Victoria, Australia
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Subiaco, Western Australia, Australia
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Curitiba, , Brazil
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Itapira, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Medicine Hat, Alberta, Canada
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Kelowna, British Columbia, Canada
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Penticton, British Columbia, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Paris, , France
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Rennes, , France
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Strasbourg, , France
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Toulouse, , France
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Berlin, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Mannheim, , Germany
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Munich, , Germany
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Regensburg, , Germany
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Baggiovara, , Italy
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Biella, , Italy
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Chieti, , Italy
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Genova, , Italy
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Lido di Camaiore, , Italy
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Milan, , Italy
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Rome, , Italy
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Aichi, , Japan
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Ehime, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Hyōgo, , Japan
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Kanagawa, , Japan
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Kyoto, , Japan
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Osaka, , Japan
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Shizuoka, , Japan
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Tokyo, , Japan
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Bydgoszcz, , Poland
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Gliwice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Chelyabinsk, , Russia
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Saint Petersburg, , Russia
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Incheon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Barcelona, , Spain
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Getafe, , Spain
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Madrid, , Spain
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Plasencia, , Spain
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Terrassa, , Spain
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Jönköping, , Sweden
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Kalmar, , Sweden
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Lund, , Sweden
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Mölndal, , Sweden
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Umeå, , Sweden
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Guishan, , Taiwan
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Niaosong, , Taiwan
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Taipei, , Taiwan
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Uckfield, E Susx, United Kingdom
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Scotland, Glasgow, United Kingdom
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London, Greater London, United Kingdom
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Camberwell, London, United Kingdom
Site Status
Countries
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United States
Argentina
Australia
Brazil
Canada
France
Germany
Italy
Japan
Poland
Russia
South Korea
Spain
Sweden
Taiwan
United Kingdom
Other Identifiers
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H8A-MC-LZAO
Identifier Type: OTHER
Identifier Source: secondary_id
11935
Identifier Type: -
Identifier Source: org_study_id
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