At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 326 enrolled
Drug / intervention
Irsenontrine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies
In Brief
A Phase 2 clinical trial evaluating Irsenontrine and Placebo for Dementia With Lewy Bodies. Completed, enrolled 326 participants across 74 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia With Lewy Bodies
CountriesFrance, Germany, Italy, Japan, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartMay 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedMar 15, 2018
Enrollment StartMay 4, 2018
Primary CompletionApr 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.3 years ago
Interventions
Irsenontrinedrug
Oral hypromellose capsules.
Placebodrug
Oral hypromellose capsules.