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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: Completed Phase 1 study, sponsored by Eisai.

NCT01600859 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 65 participants
Start Date 2012-07
Est. Completion 2013-10
Phase Phase 1
Eisai

287 total trials

What the finished NCT01600859 record still lists

NCT01600859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which E2609 is the first listed.

NCT01600859 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01600859's enrollment target sits among peer trials

65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01600859, the US trial registry maintained by the National Library of Medicine. NCT01600859 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.