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NCT01600859 · ClinicalTrials.gov registry record · Phase 1
Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT01600859 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 65 participants.
The verdict
NCT01600859, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor (AChEI) and/or memantine for AD must be on a stable dose for at least 12 weeks prior to Screening and remain on their stable dose throughout the trial. Subjects will receive placebo or a single oral dose of E2609. Safety assessments will be conducted. Additionally, the pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid biomarkers and cognitive and psychological measures.
Interventions
- DRUG E2609
- DRUG Placebo for E2609
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01600859
The ClinicalTrials.gov registry entry for NCT01600859 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which E2609 is the first listed.
NCT01600859 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01600859 about?
NCT01600859 is a clinical study titled "Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)". Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor (AChEI) and/or memantine for AD ...
What is the current status of trial NCT01600859?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2012-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01600859?
The interventions under investigation include: E2609 (DRUG), Placebo for E2609 (DRUG).
Who is sponsoring clinical trial NCT01600859?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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