Trial Outcomes & Findings for A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology (NCT NCT04764669)
NCT ID: NCT04764669
Last Updated: 2022-09-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Baseline, Week 9
Results posted on
2022-09-26
Participant Flow
Participants took part in the study at 15 investigative sites in the United States, and Canada from 25 Feb 2021 to 27 Jan 2022.
A total of 83 participants were screened, of which 49 were screen failures and 34 participants received the study treatment.
Participant milestones
| Measure |
DLB Without Amyloid Copathology
Participants with dementia with Lewy bodies (DLB) (without amyloid copathology) received E2027 50 milligram (mg) capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
Participants with Parkinson's Disease Dementia (PDD) (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
10
|
3
|
|
Overall Study
COMPLETED
|
7
|
11
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
DLB Without Amyloid Copathology
Participants with dementia with Lewy bodies (DLB) (without amyloid copathology) received E2027 50 milligram (mg) capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
Participants with Parkinson's Disease Dementia (PDD) (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
|
Overall Study
Subject Choice
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
Baseline Characteristics
A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology
Baseline characteristics by cohort
| Measure |
DLB Without Amyloid Copathology
n=10 Participants
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 Participants
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 Participants
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 Participants
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 6.21 • n=5 Participants
|
73.9 years
STANDARD_DEVIATION 6.07 • n=7 Participants
|
74.4 years
STANDARD_DEVIATION 6.40 • n=5 Participants
|
78.3 years
STANDARD_DEVIATION 2.52 • n=4 Participants
|
73.9 years
STANDARD_DEVIATION 6.00 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 9Population: Pharmacodynamic (PD) analysis set included participants who had sufficient PD data to derive at least 1 PD parameter.
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.
Outcome measures
| Measure |
DLB Without Amyloid Copathology
n=9 Participants
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=10 Participants
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 Participants
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 Participants
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at Week 9
|
230.412 Percent Change in CSF (ng/mL)
Standard Error 20.417
|
250.434 Percent Change in CSF (ng/mL)
Standard Error 17.015
|
186.869 Percent Change in CSF (ng/mL)
Standard Error 24.374
|
362.519 Percent Change in CSF (ng/mL)
Standard Error 40.764
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Week 16Population: Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.
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.
Outcome measures
| Measure |
DLB Without Amyloid Copathology
n=10 Participants
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 Participants
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 Participants
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 Participants
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation
TEAEs
|
6 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation
Severe TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation
AE Leading to Discontinuation from Study
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation
Serious TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 3, Week 6, Week 9, Week 12 and Week 16Population: Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.
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.
Outcome measures
| Measure |
DLB Without Amyloid Copathology
n=10 Participants
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 Participants
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 Participants
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 Participants
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Orthostatic Hypotension
Week 12
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Orthostatic Hypotension
Week 16
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Orthostatic Hypotension
Week 3
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Orthostatic Hypotension
Week 6
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Orthostatic Hypotension
Week 9
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Week 16Population: Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.
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).
Outcome measures
| Measure |
DLB Without Amyloid Copathology
n=10 Participants
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 Participants
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 Participants
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 Participants
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Post Baseline Treatment Emergent Orthostatic Tachycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Week 16Population: 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.
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.
Outcome measures
| Measure |
DLB Without Amyloid Copathology
n=10 Participants
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 Participants
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 Participants
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 Participants
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Laboratory Values
Creatinine: Markedly Abnormal High
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Values
Lymphocytes: Markedly Abnormal Low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Laboratory Values
Potassium: Markedly Abnormal High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Week 16Population: Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.
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.
Outcome measures
| Measure |
DLB Without Amyloid Copathology
n=10 Participants
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 Participants
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 Participants
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 Participants
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Post-Baseline Abnormal Electrocardiogram (ECG) Findings
QTcF prolonged to >500 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Change from baseline of PR >= 25% to an absolute PR value of >220 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Change from baseline of QRS >= 25% to an absolute QRS value of >120 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Abnormal Electrocardiogram (ECG) Findings
QTcF prolongation by >60 ms from baseline and absolute QTcF >450 ms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Week 16Population: Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.
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.
Outcome measures
| Measure |
DLB Without Amyloid Copathology
n=10 Participants
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 Participants
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 Participants
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 Participants
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Suicide Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Preparatory Actions Towards Imminent Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Wish to Die
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Actual Suicidal Thoughts; Non-specific
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Actual Suicidal Thoughts with Method; No Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Active Thoughts with Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Active Thoughts with Plan and Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Self-injurious Behavior; No Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 16Population: 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.
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.
Outcome measures
| Measure |
DLB Without Amyloid Copathology
n=10 Participants
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 Participants
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 Participants
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 Participants
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III)
Baseline
|
21.1 score on a scale
Standard Deviation 9.81
|
24.6 score on a scale
Standard Deviation 12.33
|
28.9 score on a scale
Standard Deviation 12.35
|
38.0 score on a scale
Standard Deviation 19.00
|
|
Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III)
Change at Week 12
|
5.0 score on a scale
Standard Deviation 4.61
|
6.5 score on a scale
Standard Deviation 7.20
|
2.8 score on a scale
Standard Deviation 10.67
|
-4.0 score on a scale
Standard Deviation 5.29
|
|
Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III)
Change at Week 16
|
1.1 score on a scale
Standard Deviation 13.92
|
2.1 score on a scale
Standard Deviation 8.01
|
4.3 score on a scale
Standard Deviation 17.01
|
2.3 score on a scale
Standard Deviation 2.31
|
Adverse Events
DLB Without Amyloid Copathology
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
DLB With Amyloid Copathology
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PDD Without Amyloid Copathology
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PDD With Amyloid Copathology
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DLB Without Amyloid Copathology
n=10 participants at risk
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 participants at risk
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 participants at risk
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 participants at risk
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
General disorders
Death
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
Other adverse events
| Measure |
DLB Without Amyloid Copathology
n=10 participants at risk
Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
DLB With Amyloid Copathology
n=11 participants at risk
Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD Without Amyloid Copathology
n=10 participants at risk
Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
PDD With Amyloid Copathology
n=3 participants at risk
Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
33.3%
1/3 • From first dose of study drug up to Week 16
|
|
General disorders
Pyrexia
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
General disorders
Temperature intolerance
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Infections and infestations
Ear infection
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
33.3%
1/3 • From first dose of study drug up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Nervous system disorders
Akathisia
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
33.3%
1/3 • From first dose of study drug up to Week 16
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Psychiatric disorders
Aggression
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Psychiatric disorders
Delusion
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Psychiatric disorders
Hallucination
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
9.1%
1/11 • From first dose of study drug up to Week 16
|
10.0%
1/10 • From first dose of study drug up to Week 16
|
0.00%
0/3 • From first dose of study drug up to Week 16
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
0.00%
0/11 • From first dose of study drug up to Week 16
|
0.00%
0/10 • From first dose of study drug up to Week 16
|
33.3%
1/3 • From first dose of study drug up to Week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place