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NCT03367403 · ClinicalTrials.gov registry record · Phase 2
A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
A Phase 2 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 272
- Enrollment target
- 20
- Study locations
NCT03367403: Completed Phase 2 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
NCT03367403 is a Phase 2 study of Alzheimer Disease that has completed, run by Eli Lilly and Company. The registered enrollment target is 272 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03367403, a Phase 2 study of Alzheimer Disease, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 272 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.
Primary Outcome
Integrated Alzheimer's Disease Rating Scale is used to assess whether donanemab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). The scale ranges from 0 to 144, where lower scores indicate worse performance and higher score indicates bet
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Donanemab
- DRUG LY3202626
Study Locations (20)
Florida
- JEM Research Institute - Atlantis
- Bradenton Research Center - Bradenton
- Brain Matters Research - Delray Beach
- Infinity Clinical Research, LLC - Hollywood
- Jacksonville Center for Clinical Research - Jacksonville
- Merritt Island Medical Research LLC - Merritt Island
- Pharmax Research Clinic - Miami
- Miami Jewish Health Systems - Miami
- Suncoast Clinical Research - New Port Richey
California
- Neurology Center of North Orange County - Fullerton
- Irvine Clinical Research Center - Irvine
- Institute for Memory Impairment & Neurological Disorders - Irvine
- Pharmacology Research Institute - Newport Beach
- Pacific Research Network Inc - San Diego
- Sharp Mesa Vista Hospital - San Diego
- Syrentis Clinical Research - Santa Ana
Arizona
- Banner Alzheimer's Institute - Phoenix
- Banner Sun Health Research Institute - Sun City
Connecticut
- Associated Neurologists, PC - Danbury - Danbury
- KI Health Partners, LLC d/b/a NE Inst. for Clin. Res. - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2017-12-18 |
| Est. Completion | 2021-09-21 |
| Phase | Phase 2 |
What the finished NCT03367403 record still lists
NCT03367403 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03367403 names 20 study sites across 4 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03367403 about?
NCT03367403 is a clinical study titled "A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)". The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.
What is the current status of trial NCT03367403?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 272 participants. The study started on 2017-12-18. Estimated completion is 2021-09-21.
What conditions does trial NCT03367403 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT03367403?
The interventions under investigation include: Placebo (DRUG), Donanemab (DRUG), LY3202626 (DRUG).
Who is sponsoring clinical trial NCT03367403?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03367403 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03367403's enrollment target sits among peer trials
272 86th of 306 higher than 221 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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