Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00594568 · ClinicalTrials.gov registry record · Phase 3
Effect of LY450139 on the Long Term Progression of Alzheimer's Disease
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,537
- Enrollment target
NCT00594568 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,537 participants.
The verdict
NCT00594568, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,537 participants
- Enrollment target
Study Summary
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta-amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid, and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some participants. The build-up of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some participants. In this trial, participants who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all participants could eventually receive active drug. Participation could last approximately 2 years. Participants taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All participants who completed this study had the option to continue receiving semagacestat by participating in an open-label study. Preliminary results from this study (H6L-MC-LFAN \[LFAN\]) and another similar study (H6L-MC-LFBC \[LFBC; NCT00762411\]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC, and open-label H6L-MC-LFBF (LFBF; NCT01035138) were am
Interventions
- DRUG Placebo
- DRUG LY450139
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,537 participants |
| Start Date | 2008-03 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00594568
The ClinicalTrials.gov registry entry for NCT00594568 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,537 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00594568 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00594568 about?
NCT00594568 is a clinical study titled "Effect of LY450139 on the Long Term Progression of Alzheimer's Disease". Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta-amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have ...
What is the current status of trial NCT00594568?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,537 participants. The study started on 2008-03. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00594568?
The interventions under investigation include: Placebo (DRUG), LY450139 (DRUG).
Who is sponsoring clinical trial NCT00594568?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.