Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
ClinicalTrials.gov processed this data on September 20, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS(See Contacts and Locations)
Verified September 2024 by Eli Lilly and Company
Sponsor
Eli Lilly and CompanyInformation Provided by (Responsible Party)
Eli Lilly and CompanyClinicaltrials.gov Identifier
NCT04437511Other Study ID Numbers: 17737
First Submitted: June 17, 2020
First Posted: June 18, 2020
Results First Posted: May 20, 2024
Last Update Posted: September 23, 2024
Last Verified: September 2024
History of Changes
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Tracking Information | |
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First Submitted Date | June 17, 2020 |
First Posted Date | June 18, 2020 |
Results First Submitted Date | April 10, 2024 |
Results First Posted Date | May 20, 2024 |
Last Update Posted Date | September 23, 2024 |
Study Start Date | June 19, 2020 |
Actual Primary Completion Date | April 14, 2023 |
Current Primary Outcome Measures(submitted: September 20, 2024) |
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Change History | Complete list of historical versions of study NCT04437511 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided |
Descriptive Information | |
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Brief Title | A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) |
Official Title | Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease |
Brief Summary | The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. |
Detailed Description | TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (donanemab) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain amyloid and tau pathology. Following the double-blind 76-week main study period, a double-blind 78-week long-term extension period is added to further evaluate donanemab efficacy and safety over time. Participants from the addendum safety cohort are not eligible for the extension period. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: RandomizedInterventional Model: Parallel AssignmentMasking: DoublePrimary Purpose: Treatment |
Target Follow-Up Duration | Not Provided |
Biospecimen | Not Provided |
Sampling Method | Not Provided |
Study Population | Not Provided |
Condition |
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Intervention | Drug: Donanemab Given IV |
Study Groups/Cohorts | Experimental: DonanemabParticipants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks Intervention:
Placebo Comparator: PlaceboParticipants received placebo given IV. Intervention:
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Publications * | Not Provided |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
Recruitment Information | |
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Recruitment Status | Active, not recruiting |
Actual Enrollment(submitted: September 20, 2024) | 1736 |
Anticipated Study Completion Date | August 22, 2025 |
Actual Primary Study Completion Date | April 14, 2023 |
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender | Sexes Eligible for Study: All |
Ages | 60 Years to 85 Years (Adult, Older Adult) |
Accepts Healthy Volunteers | No |
Contacts | Contact information is only displayed when the study is recruiting subjects |
Listed Location Countries | United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, Australia, Australia, Australia, Australia, Australia, Australia, Australia, Australia, Australia, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Canada, Czechia, Czechia, Czechia, Czechia, Czechia, Czechia, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Japan, Netherlands, Netherlands, Netherlands, Netherlands, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Poland, Puerto Rico, Puerto Rico, Puerto Rico, Puerto Rico, United Kingdom, United Kingdom, United Kingdom, United Kingdom |
Administrative Information | |
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NCT Number | NCT04437511 |
Other Study ID Numbers | 17737 |
Has Data Monitoring Committee | Yes |
U.S FDA-regulated Product | Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: Not Provided |
IPD Sharing Statement | Plan to Share IPD: Yes |
Responsible Party | Eli Lilly and Company, Eli Lilly and Company |
Study Sponsor | Eli Lilly and Company |
Collaborators | Not Provided |
Investigators | |
PRS Account | Eli Lilly and Company |
Verification Date | September 2024 |