Trial · NCT04764669
A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology
NCT04764669, Phase 2, Completed, Eisai Inc.; results first posted 2022-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology. Trials, record NCT04764669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04764669
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology
- NCT number
- NCT04764669
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Lewy Body Disease, Parkinson Disease
- Interventions
- E2027
- First posted
- 2021-02-21
- Last updated
- 2022-09-26
- Results first posted
- 2022-09-26
- Limitations and caveats
- Due to insufficient numbers enrolled of participants with PDD and amyloid copathology, interpretation of results in this subgroup is limited.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at Week 9 | Baseline, Week 9 | cGMP was measured in CSF samples using a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantitative at 0.500 nanogram per milliliter (ng/ml). Evaluation of cGMP following dosing of E2027 was based on relative percent change from baseline. |
| 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 during treatment, having been absent at pretreatment or reemerged during treatment, having been present at pretreatment but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE is continuous. Severe TEAE was defined as inability to work or to perform normal daily activity. A Serious TEAE was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria. An AE was defined as any untoward medical occurrence in a participant administered an investigational product. AE resulting in study discontinuation was defined as AE due to which the study medication was stopped. |
| Secondary | Number of Participants With Treatment Emergent Orthostatic Hypotension | Week 3, Week 6, Week 9, Week 12 and Week 16 | Orthostatic hypotension was defined based on the following criteria per protocol: Drop in standing systolic blood pressure (SBP) greater than or equal to (\>=) 20 millimeter of mercury (mmHg) compared to supine or drop in standing diastolic blood pressure (DBP) \>=10 mmHg compared to supine. Treatment-emergent orthostatic hypotension was defined as: if at baseline participant did not have SBP drop \>=20 mmHg and no DBP drop \>=10 mmHg, but developed one or more of these two events during post baseline visits. |
| Secondary | Number of Participants With Post Baseline Treatment Emergent Orthostatic Tachycardia | From first dose of study drug up to Week 16 | Orthostatic tachycardia was defined by the following criteria per protocol: Standing heart rate (HR) increased by greater than (\>) 30 beats/min compared to supine and absolute standing HR was \>100 beats/min. A participant was counted as treatment-emergent if orthostatic tachycardia emerged during the treatment, having been absent at baseline (pretreatment). |
| Secondary | Number of Participants With Markedly Abnormal Laboratory Values | From first dose of study drug up to Week 16 | A laboratory value was determined to be a markedly abnormal value if the postbaseline grade increased from baseline and the post-baseline grade was greater than or equal to 2. Markedly abnormal laboratory values were based on Common Terminology Criteria for Adverse events (CTCAE) Version 5.0. |
| Secondary | Number of Participants With Post-Baseline Abnormal Electrocardiogram (ECG) Findings | From first dose of study drug up to Week 16 | Abnormal ECG findings were defined as follows: corrected QT interval calculated using Fridericia's formula (QTcF) prolonged by \>60 millisecond (ms) from baseline and absolute QTcF \>450 ms; QTcF prolonged to \>500 ms; Change from baseline of PR interval \>=25 percent (%) to an absolute PR value of \>220 ms; Change from baseline of QRS interval \>=25% to an absolute QRS value of \>120 ms. |
| Secondary | Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS) | From first dose of study drug up to Week 16 | The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories); is an interview-based instrument to systematically assess suicidal ideation and suicidal behavior. C-SSRS assess whether participant experience any of the following: completed suicide; suicide attempt (response of "yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Here, number of participants with positive response ("yes") to suicidal behavior or/and Ideation, any non-suicidal self-injurious behavior was reported. |
| Secondary | Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III) | Baseline, Week 12 and Week 16 | The UPDRS scale evaluates extrapyramidal features in motor function in Parkinson's disease. It contains 33 items in 18 categories: (1) speech, (2) facial expression, (3) rigidity, (4) finger tapping, (5) hand movements, (6) supinational and pronation movements of hands, (7) toe tapping, (8) leg agility, (9) arising from chair, (10) gait, (11) freezing of gait, (12) postural stability, (13) posture, (14) body bradykinesia, (15) postural tremor of hands, (16) kinetic tremor of hands, (17) rest tremor amplitude and (18) constancy of rest tremor. Each item is scored 0 to 4, giving a total score range 0 to 132. Higher scores indicating more severe symptoms. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at Week 9 | Baseline, Week 9 | Pharmacodynamic (PD) analysis set included participants who had sufficient PD data to derive at least 1 PD parameter. | Percent Change in CSF (ng/mL) | LEAST_SQUARES_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 | Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Orthostatic Hypotension | Week 3, Week 6, Week 9, Week 12 and Week 16 | Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Post Baseline Treatment Emergent Orthostatic Tachycardia | From first dose of study drug up to Week 16 | Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Markedly Abnormal Laboratory Values | From first dose of study drug up to Week 16 | Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. Number analyzed n are the participants who were evaluable for the outcome measure for given categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Post-Baseline Abnormal Electrocardiogram (ECG) Findings | From first dose of study drug up to Week 16 | Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS) | From first dose of study drug up to Week 16 | Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III) | Baseline, Week 12 and Week 16 | Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at Week 9 | DLB Without Amyloid Copathology | 230.412 | Standard Error 20.417 | Percent Change in CSF (ng/mL) | |
| Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at Week 9 | DLB With Amyloid Copathology | 250.434 | Standard Error 17.015 | Percent Change in CSF (ng/mL) | |
| Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at Week 9 | PDD Without Amyloid Copathology | 186.869 | Standard Error 24.374 | Percent Change in CSF (ng/mL) | |
| Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at Week 9 | PDD With Amyloid Copathology | 362.519 | Standard Error 40.764 | Percent Change in CSF (ng/mL) | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation | DLB Without Amyloid Copathology | TEAEs | 6 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation | DLB With Amyloid Copathology | TEAEs | 4 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation | PDD Without Amyloid Copathology | TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation | PDD With Amyloid Copathology | TEAEs | 2 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation | DLB Without Amyloid Copathology | Severe TEAEs | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation | DLB With Amyloid Copathology | Severe TEAEs | 0 | Participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DLB Without Amyloid Copathology | 10 | |
| Overall Study | STARTED | DLB With Amyloid Copathology | 11 | |
| Overall Study | STARTED | PDD Without Amyloid Copathology | 10 | |
| Overall Study | STARTED | PDD With Amyloid Copathology | 3 | |
| Overall Study | COMPLETED | DLB Without Amyloid Copathology | 7 | |
| Overall Study | COMPLETED | DLB With Amyloid Copathology | 11 | |
| Overall Study | COMPLETED | PDD Without Amyloid Copathology | 8 | |
| Overall Study | COMPLETED | PDD With Amyloid Copathology | 3 | |
| Overall Study | NOT COMPLETED | DLB Without Amyloid Copathology | 3 | |
| Overall Study | NOT COMPLETED | DLB With Amyloid Copathology | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
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 | Bradycardia | Cardiac disorders | DLB Without Amyloid Copathology | 0 | 10 | |
| other | Bradycardia | Cardiac disorders | DLB With Amyloid Copathology | 1 | 11 | |
| other | Bradycardia | Cardiac disorders | PDD Without Amyloid Copathology | 0 | 10 | |
| other | Bradycardia | Cardiac disorders | PDD With Amyloid Copathology | 0 | 3 | |
| other | Supraventricular tachycardia | Cardiac disorders | DLB Without Amyloid Copathology | 0 | 10 | |
| other | Supraventricular tachycardia | Cardiac disorders | DLB With Amyloid Copathology | 1 | 11 | |
| other | Supraventricular tachycardia | Cardiac disorders | PDD Without Amyloid Copathology | 0 | 10 | |
| other | Supraventricular tachycardia | Cardiac disorders | PDD With Amyloid Copathology | 0 | 3 | |
| other | Abdominal discomfort | Gastrointestinal disorders | DLB Without Amyloid Copathology | 0 | 10 | |
| other | Abdominal discomfort | Gastrointestinal disorders | DLB With Amyloid Copathology | 0 | 11 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DLB Without Amyloid Copathology | 1 | 10 |
| Total, all-cause mortality | DLB With Amyloid Copathology | 0 | 11 |
| Total, all-cause mortality | PDD Without Amyloid Copathology | 0 | 10 |
| Total, all-cause mortality | PDD With Amyloid Copathology | 0 | 3 |
| Total, other adverse events | DLB Without Amyloid Copathology | 5 | 10 |
| Total, other adverse events | DLB With Amyloid Copathology | 4 | 11 |
| Total, other adverse events | PDD Without Amyloid Copathology | 3 | 10 |
| Total, other adverse events | PDD With Amyloid Copathology | 2 | 3 |
| Total, serious adverse events | DLB Without Amyloid Copathology | 1 | 10 |
| Total, serious adverse events | DLB With Amyloid Copathology | 0 | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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