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NCT01837641 · ClinicalTrials.gov registry record · Phase 1
A Study of LY3002813 in Participants With Alzheimer's Disease
A Phase 1 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 6
- Study locations
NCT01837641: Completed Phase 1 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
NCT01837641 is a Phase 1 study of Alzheimer Disease that has completed, run by Eli Lilly and Company. The registered enrollment target is 63 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01837641, a Phase 1 study of Alzheimer Disease, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 6
- Study locations
Study Summary
The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813. Study participants will be healthy or will have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD. There will be seven groups of study participants. Five groups will receive a single dose of LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo given as an injection into a vein. Approximately 12 weeks will pass between the single dose and the first multiple dose. One group of participants will receive a single dose of LY3002813 given as an injection under the skin. One group of participants will receive a single dose of LY3002813 given as an injection into a vein.
Primary Outcome
Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.
Conditions Studied
Interventions
- BIOLOGICAL LY3002813-IV
- BIOLOGICAL LY3002813-SC
- DRUG Placebo-IV
Study Locations (6)
Other
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Sumida-Ku
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Tokyo
California
- Collaborative Neuroscience Network - CNS - Long Beach
Florida
- Compass Research - Orlando
Georgia
- Atlanta Center of Medical Research - Atlanta
Utah
- PRAHealthSciences - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-05-03 |
| Est. Completion | 2016-08-24 |
| Phase | Phase 1 |
What the finished NCT01837641 record still lists
NCT01837641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 3 interventions - of which LY3002813-IV is the first listed.
NCT01837641 lists 6 locations in 5 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT01837641 about?
NCT01837641 is a clinical study titled "A Study of LY3002813 in Participants With Alzheimer's Disease". The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813. Study participants will be healthy or will have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD. There will be seven...
What is the current status of trial NCT01837641?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2013-05-03. Estimated completion is 2016-08-24.
What conditions does trial NCT01837641 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT01837641?
The interventions under investigation include: LY3002813-IV (BIOLOGICAL), LY3002813-SC (BIOLOGICAL), Placebo-IV (DRUG).
Who is sponsoring clinical trial NCT01837641?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01837641 being conducted?
This trial has 6 study locations across California, Florida, Georgia, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01837641's enrollment target sits among peer trials
63 184th of 306 higher than 123 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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