Trial · NCT03467152
Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies
NCT03467152, Phase 2, Completed, Eisai Inc.; results first posted 2022-08-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies. Trials, record NCT03467152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03467152
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies
- NCT number
- NCT03467152
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 326 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Dementia With Lewy Bodies
- Interventions
- Irsenontrine, Placebo
- First posted
- 2018-03-15
- Last updated
- 2022-08-01
- Other registries' IDs
- eudract:2017-003728-64
- Results first posted
- 2022-08-01
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment | Baseline and Week 12 | 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. |
| Primary | Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment | Week 12 | Number of participants are reported categorized in grades based on the CIBIC-Plus scale. The CIBIC-Plus scale is designed to measure various domains that describe participant function: general, mental/cognitive state, behavior, and activities of daily living. It is a semi-structured global rating derived from a comprehensive interview with the participant and caregiver or informant by an independent rater who has no access to the source data or other psychometric test scores conducted post-randomization as part of the protocol. The CIBIC-Plus was a 7-point scale and scores were: 1 (marked improvement), 2 (moderate improvement), 3 (minimal improvement), 4 (no change), 5 (minimal worsening), 6 (moderate worsening), and 7 (marked worsening). Higher values represent a worse outcome. |
| Secondary | Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale at Week 12 of Treatment | Week 12 | Number of participants are reported categorized in grades based on the CGIC-DLB scale. The CGIC-DLB scale provided an overall clinician-determined summary measure of change from the participant's clinical status that takes into account all available information from the efficacy endpoints (which include cognitive function, non-cognitive symptoms, behavior, and the impact of the symptoms on the participant's ability to function) and safety data. The (CGIC-DLB) was a 7-point scale and scores were: 1 (marked improvement), 2 (moderate improvement), 3 (minimal improvement), 4 (no change), 5 (minimal worsening), 6 (moderate worsening), and 7 (marked worsening). Higher values represent a worse outcome. |
| Secondary | Mean Change From Baseline in the Cognitive Fluctuation Inventory (CFI) Score at Week 12 of Treatment | Baseline and Week 12 | The CFI scale assessed cognitive fluctuation. It evaluates fluctuation in various domains including attention, ability to perform daily functions, orientation, verbal communication and behavior. The score was based on frequency and severity with a score range of 0 to 12. The scale also assessed the degree of caregiver or informant distress engendered by the symptoms. Higher scores indicating greater impairment. |
| Secondary | Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Total Score Week 12 of Treatment | Baseline and Week 12 | The MMSE is a 30-point scale that measured orientation to time and place, registration, immediate and delayed recall, attention, language, and drawing. The total score ranges from 0 (most impaired) to 30 (no impairment). The lower score means severe cognitive deficit and higher score indicates better function. |
| Secondary | Mean Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Total Score at Week 12 of Treatment | Baseline and Week 12 | The NPI-12 scale assessed the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. The scale also assessed the degree of caregiver or informant distress engendered by each of the symptoms. The sum of the composite scores for the 12 domains yielded the NPI-12 total score. NPI-12 total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater neuropsychiatric disturbance. |
| Secondary | Change From Baseline in NPI-4 Subscore at Week 12 | Baseline and Week 12 | The NPI scale assesses the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. NPI-4 is the subscore covering the domains of delusions, hallucinations, apathy and depression. NPI-4 total subscore ranged from 0 to 48, with higher scores indicating a greater neuropsychiatric disturbance. |
| Secondary | Change From Baseline in NPI-10 Subscore at Week 12 | Baseline and Week 12 | The NPI-10 assessed range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently)\*Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, the range for total score is 0 to 120. Higher scores indicating a greater neuropsychiatric disturbance. |
| Secondary | Change From Baseline in NPI-D (Caregiver Distress) Total Score at Week 12 | Baseline and Week 12 | The NPI-D scale assesses the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. The scale assesses the degree of caregiver distress engendered by each of the symptoms. The caregiver distress (NPI-D) is rated by caregiver based on his or her own stress on a five point scale from 0 to 5, where: 0(no distress), 1(minimal), 2(mild), 3(moderate), 4(moderately severe), 5(very severe or extreme). NPI-D total score is calculated by summing the scores of the 12 sub-scale distress scores. The NPI-D total scores ranges from 0 to 60 with higher scores indicating greater distress. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation | From first dose of study drug up to Week 16 | A TEAE was defined as an AE that emerged or worsened in severity relative to baseline during treatment or within 28 days after the last dose of study drug. Severe TEAE was defined as inability to work or to perform normal daily activity. A Serious TEAE is any untoward medical occurrence that at any dose: results in death; is life threatening (that is, the participant was at immediate risk of death from the adverse event as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| PRIMARY | Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment | Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale at Week 12 of Treatment | Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in the Cognitive Fluctuation Inventory (CFI) Score at Week 12 of Treatment | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Total Score Week 12 of Treatment | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Total Score at Week 12 of Treatment | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in NPI-4 Subscore at Week 12 | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in NPI-10 Subscore at Week 12 | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in NPI-D (Caregiver Distress) Total Score at Week 12 | Baseline and Week 12 | The full analysis set included the group of randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post randomization coprimary efficacy measurement. Here overall number analyzed N are the participants who were evaluable for the outcome measure and number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation | From first dose of study drug up to Week 16 | The safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post randomization safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment | Placebo | Baseline | 13.9 | Standard Deviation 5.40 | score on a scale |
| Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment | Irsenontrine 50 mg | Baseline | 13.8 | Standard Deviation 5.18 | score on a scale |
| Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment | Placebo | Change at Week 12 | -0.6 | Standard Deviation 2.63 | score on a scale |
| Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment | Irsenontrine 50 mg | Change at Week 12 | -0.4 | Standard Deviation 3.41 | score on a scale |
| Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment | Placebo | Marked improvement | 0 | Participants | |
| Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment | Irsenontrine 50 mg | Marked improvement | 0 | Participants | |
| Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment | Placebo | Moderate improvement | 5 | Participants | |
| Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment | Irsenontrine 50 mg | Moderate improvement | 3 | Participants | |
| Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment | Placebo | Minimal improvement | 13 | Participants | |
| Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment | Irsenontrine 50 mg | Minimal improvement | 18 | Participants |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 100 | |
| Overall Study | STARTED | Irsenontrine 50 mg | 100 | |
| Overall Study | STARTED | Randomised, Not Treated Due to Site Closure | 6 | |
| Overall Study | Treated | Placebo | 97 | |
| Overall Study | Treated | Irsenontrine 50 mg | 99 | |
| Overall Study | Treated | Randomised, Not Treated Due to Site Closure | 0 | |
| Overall Study | COMPLETED | Placebo | 84 | |
| Overall Study | COMPLETED | Irsenontrine 50 mg | 89 | |
| Overall Study | COMPLETED | Randomised, Not Treated Due to Site Closure | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events348
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood loss anaemia | Blood and lymphatic system disorders | Placebo | 1 | 97 | 1 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Irsenontrine 50 mg | 0 | 99 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Placebo | 0 | 97 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Irsenontrine 50 mg | 1 | 99 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 1 | 97 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Irsenontrine 50 mg | 0 | 99 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 1 | 97 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Irsenontrine 50 mg | 0 | 99 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 2 | 97 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Irsenontrine 50 mg | 0 | 99 | 0 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 97 |
| Total, all-cause mortality | Irsenontrine 50 mg | 0 | 99 |
| Total, other adverse events | Placebo | 65 | 97 |
| Total, other adverse events | Irsenontrine 50 mg | 68 | 99 |
| Total, serious adverse events | Placebo | 9 | 97 |
| Total, serious adverse events | Irsenontrine 50 mg | 7 | 99 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42026627 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Irsenontrine 50 mg vs Placebo: deaths from any cause | Trial comparisons |
| Irsenontrine 50 mg vs Placebo: Number of Participants With Orthostatic Tachycardia | Trial comparisons |
| Irsenontrine 50 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03467152
GET https://conductscience.org/api/trials/v1/NCT03467152/results?page=2