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NCT03467152 · ClinicalTrials.gov registry record · Phase 2

Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies

A Phase 2 study, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
326
Enrollment target

NCT03467152: Completed Phase 2 study, sponsored by Eisai.

NCT03467152 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 326 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (145% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03467152, a Phase 2 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 2
Development phase
326 participants
Enrollment target

Study Summary

This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.

Primary Outcome

The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.

Interventions

  • DRUG Placebo
  • DRUG Irsenontrine

Trial Details

FieldValue
Enrollment Target 326 participants
Start Date 2018-05-04
Est. Completion 2020-04-15
Phase Phase 2
Eisai

287 total trials

What the finished NCT03467152 record still lists

NCT03467152 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (145% higher).

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

NCT03467152 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03467152 about?

NCT03467152 is a clinical study titled "Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies". This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies afte...

What is the current status of trial NCT03467152?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 326 participants. The study started on 2018-05-04. Estimated completion is 2020-04-15.

What interventions are being tested in trial NCT03467152?

The interventions under investigation include: Placebo (DRUG), Irsenontrine (DRUG).

Who is sponsoring clinical trial NCT03467152?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03467152's enrollment target sits among peer trials

326 147th of 2000 higher than 1,853 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT03467152, the US trial registry maintained by the National Library of Medicine. NCT03467152 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.