Trials / Completed
CompletedNCT03467152
Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Irsenontrine | Oral hypromellose capsules. |
| DRUG | Placebo | Oral hypromellose capsules. |
Timeline
- Start date
- 2018-05-04
- Primary completion
- 2020-04-15
- Completion
- 2020-04-15
- First posted
- 2018-03-15
- Last updated
- 2022-08-01
- Results posted
- 2022-08-01
Locations
74 sites across 7 countries: United States, France, Germany, Italy, Japan, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03467152. Inclusion in this directory is not an endorsement.