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NCT02624778 · ClinicalTrials.gov registry record · Phase 1
A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD
A Phase 1 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
- 9
- Study locations
NCT02624778: Completed Phase 1 study of Alzheimer Disease, sponsored by Eli Lilly and Company.
NCT02624778 is a Phase 1 study of Alzheimer Disease that has completed, run by Eli Lilly and Company. The registered enrollment target is 61 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02624778, a Phase 1 study of Alzheimer Disease, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
- 9
- Study locations
Study Summary
The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD. The study involves 3 parts. * Part A in which participants will receive a single dose of LY3002813 or placebo (no drug). * Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks. * Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks. Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.
Primary Outcome
Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. Least square (LS) mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summ
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL LY3002813
Study Locations (9)
Florida
- Brain Matters Research - Delray Beach
- Compass Research - Orlando
- Compass Research - The Villages
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. - Shinjuku-Ku
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. - Shinjuku-Ku
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. - Sumida-ku
Maryland
- SNBL Clinical Pharmacology Center Inc - Baltimore
Missouri
- St. Louis Clinical Trials, LC - St Louis
Utah
- PRA Health Sciences - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-12-22 |
| Est. Completion | 2019-08-28 |
| Phase | Phase 1 |
What the finished NCT02624778 record still lists
NCT02624778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 2,751-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 2 interventions - of which Placebo is the first listed.
NCT02624778 lists 9 locations in 5 states (Florida, Other, Maryland).
Frequently Asked Questions
What is clinical trial NCT02624778 about?
NCT02624778 is a clinical study titled "A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD". The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mil...
What is the current status of trial NCT02624778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2015-12-22. Estimated completion is 2019-08-28.
What conditions does trial NCT02624778 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT02624778?
The interventions under investigation include: Placebo (DRUG), LY3002813 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02624778?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02624778 being conducted?
This trial has 9 study locations across Florida, Maryland, Missouri, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02624778's enrollment target sits among peer trials
61 185th of 306 higher than 121 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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