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NCT01035138 · ClinicalTrials.gov registry record · Phase 3
A Study of Semagacestat for Alzheimer's Patients
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
NCT01035138 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 180 participants.
The verdict
NCT01035138, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
Study Summary
The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF). Preliminary results from LFAN and LFBC 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 LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.
Interventions
- DRUG semagacestat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01035138
The ClinicalTrials.gov registry entry for NCT01035138 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 180 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 1 intervention - of which semagacestat is the first listed.
NCT01035138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01035138 about?
NCT01035138 is a clinical study titled "A Study of Semagacestat for Alzheimer's Patients". The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safe...
What is the current status of trial NCT01035138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2009-12. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01035138?
The interventions under investigation include: semagacestat (DRUG).
Who is sponsoring clinical trial NCT01035138?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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