A Study of E2027 in Participants With Dementia With Lewy... | NCT04764669

Label	Type	Description	Intervention Names
DLB Without Amyloid Copathology	Experimental	Participants with DLB (without amyloid copathology) will receive E2027 50 milligram (mg) capsules, orally, once daily up to 12 weeks.	Drug: E2027
DLB With Amyloid Copathology	Experimental	Participants with DLB (with amyloid copathology) will receive E2027 50 mg capsules, orally, once daily up to 12 weeks.	Drug: E2027
PDD Without Amyloid Copathology	Experimental	Participants with PDD (without amyloid copathology) will receive E2027 50 mg capsules, orally, once daily up to 12 weeks.	Drug: E2027
PDD With Amyloid Copathology	Experimental	Participants with PDD (with amyloid copathology) will receive E2027 50 mg capsules, orally, once daily up to 12 weeks.	Drug: E2027

Name	Type	Description	Arm Group Labels	Other Names
E2027	Drug	Oral hypromellose capsules.	DLB With Amyloid Copathology DLB Without Amyloid Copathology PDD With Amyloid Copathology PDD Without Amyloid Copathology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at 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.	Baseline, Week 9

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, age 50 to 85 years, inclusive at time of consent
Meet criteria for probable DLB (as defined by the 4th report of the DLB Consortium) or meet criteria for probable PDD (as defined by the task force of the Movement Disorder Society).
Mini-mental state examination (MMSE) greater than (>) 14 and less than (<) 26 at Screening Visit
For DLB participants, have experienced visual hallucinations since onset of their DLB
If receiving acetylcholinesterase inhibitors (AChEIs), must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs from Screening to the end of the study.
If receiving memantine, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with memantine from Screening to the end of the study.
If receiving Parkinson's disease medications, must have been on a stable dose for at least 4 weeks before Screening Visit, with no plans for dose adjustment during the study.
Must have an identified caregiver or informant who is willing and able to provide follow up information on the participant throughout the course of the study.
Provide written informed consent.

Exclusion Criteria:

Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB or PDD, including any comorbidities detected by clinical assessment or magnetic resonance imaging (MRI) (identification of amyloid copathology is not exclusionary)
History of transient ischemic attacks or stroke within 12 months of Screening
Modified Hachinski Ischemic Scale >4
Parkinsonian (extrapyramidal) features with Hoehn and Yahr Scale (HYS) stage 4 or higher
Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
Geriatric Depression Scale (GDS) score >8
Severe visual or hearing impairment that may interfere with the participant study assessments including cognitive testing
Any contraindications to lumbar puncture
History of deep brain stimulation or other neurosurgical procedure for Parkinson's disease
Has thyroid stimulating hormone (TSH) above normal range
Abnormally low serum vitamin B12 levels (< the lower limit of normal [LLN]) for the testing laboratory
Contraindications to MRI scanning
Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB or PDD on brain MRI at Screening
Other significant pathological findings on brain MRI at Screening
Hypersensitivity to E2027 or any of the excipients
A prolonged corrected QT interval calculated using Fridericia's formula (QTcF) as demonstrated by triplicate ECG at the Screening or Baseline Visit (that is, mean value >450 millisecond [msec])
Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening
Any other clinically significant abnormalities in vital signs, ECG and laboratory values that in the opinion of the investigator, require further investigation or treatment or that may interfere with study procedures or safety
Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma of the skin, or localized prostate cancer in male participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.
Has a "yes" answer to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
Known or suspected history of drug or alcohol dependency or abuse within 2 years before Screening, current use of recreational drugs or a positive urine drug test at Screening.
Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator may affect the participant's safety or interfere with the study assessments
Taking any of the prohibited medications or not meeting the requirements regarding stable doses of permitted medications
Participation in a clinical study involving any investigational drug/device for DLB or PDD within 6 months before Screening or any other investigational drug/device in the 8 weeks or 5 half-lives (whichever is longer) of the study medication before Screening unless it can be documented that the participant was in a placebo treatment arm
Planned surgery which requires general, spinal or epidural anesthesia that will take place during the study.
Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 98 days after study drug discontinuation. No sperm donation is allowed during the study period and for 98 days after study drug discontinuation.
Females who are breastfeeding or pregnant at Screening or Baseline
Females of childbearing potential who:
- Within 28 days before study entry, did not use a highly effective method of contraception
- Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation

Facility	Status	City	State	ZIP	Country	Contacts
Banner Sun Health Research Institute		Sun City	Arizona	85351	United States
JEM Research Institute

ID	Title	Description
FG000	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.
FG001	DLB With Amyloid Copathology

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 19, 2020	Aug 30, 2022

ID	Title	Description
BG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
BG001	DLB With Amyloid Copathology	Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
BG002	PDD Without Amyloid Copathology	Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
BG003	PDD With Amyloid Copathology	Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00010 BG00111 BG00210 BG0033 BG00434

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline in Cerebrospinal Fluid (CSF) Cyclic Guanosine Monophosphate (cGMP) at 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.

Pharmacodynamic (PD) analysis set included participants who had sufficient PD data to derive at least 1 PD parameter.

Posted

Least Squares Mean

Standard Error

Percent Change in CSF (ng/mL)

Baseline, Week 9

ID	Title	Description
OG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG001	DLB With Amyloid Copathology	Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG002	PDD Without Amyloid Copathology	Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG003	PDD With Amyloid Copathology	Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.

Units	Counts
Participants	OG0009 OG00110 OG00210 OG003

Title

Denominators

Categories

Title	Measurements
	OG000230.412± 20.417 OG001250.434± 17.015 OG002186.869± 24.374 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Least squares mean difference	-20.022			2-Sided	95	-77.635	37.591					Superiority	Primary comparisons were: DLB without amyloid copathology versus DLB with amyloid copathology
OG002 OG003

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation

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.

Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.

Posted

Count of Participants

Participants

From first dose of study drug up to Week 16

ID	Title	Description
OG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG001	DLB With Amyloid Copathology

Secondary

Number of Participants With Treatment Emergent Orthostatic Hypotension

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.

Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.

Posted

Count of Participants

Participants

Week 3, Week 6, Week 9, Week 12 and Week 16

ID	Title	Description
OG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG001	DLB With Amyloid Copathology	Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG002	PDD Without Amyloid Copathology	Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.

Secondary

Number of Participants With Post Baseline Treatment Emergent Orthostatic Tachycardia

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).

Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.

Posted

Count of Participants

Participants

From first dose of study drug up to Week 16

ID	Title	Description
OG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG001	DLB With Amyloid Copathology	Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG002	PDD Without Amyloid Copathology	Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.

Secondary

Number of Participants With Markedly Abnormal Laboratory Values

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.

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.

Posted

Count of Participants

Participants

From first dose of study drug up to Week 16

ID	Title	Description
OG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG001	DLB With Amyloid Copathology	Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG002	PDD Without Amyloid Copathology	Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.

Secondary

Number of Participants With Post-Baseline Abnormal Electrocardiogram (ECG) Findings

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.

Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.

Posted

Count of Participants

Participants

From first dose of study drug up to Week 16

ID	Title	Description
OG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG001	DLB With Amyloid Copathology	Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG002	PDD Without Amyloid Copathology	Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.

Secondary

Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)

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.

Safety analysis set included participants who received at least 1 dose of study drug and had at least 1 post baseline safety assessment.

Posted

Count of Participants

Participants

From first dose of study drug up to Week 16

ID	Title	Description
OG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG001	DLB With Amyloid Copathology

Secondary

Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III)

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.

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 12 and Week 16

ID	Title	Description
OG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.
OG001	DLB With Amyloid Copathology	Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0020 affected10 at risk EG0030 affected3 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0020 affected10 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0010 affected11 at risk EG0021 affected10 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0010 affected11 at risk EG0021 affected10 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Pyrexia	General disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0020 affected10 at risk EG003
Temperature intolerance	General disorders	MedDRA Version 24.1	Systematic Assessment	EG0001 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Ear infection	Infections and infestations	MedDRA Version 24.1	Systematic Assessment	EG0001 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0020 affected10 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0020 affected10 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0010 affected11 at risk EG0021 affected10 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0020 affected10 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Systematic Assessment	EG0001 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Akathisia	Nervous system disorders	MedDRA Version 24.1	Systematic Assessment	EG0001 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Headache	Nervous system disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0020 affected10 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0020 affected10 at risk EG003
Aggression	Psychiatric disorders	MedDRA Version 24.1	Systematic Assessment	EG0001 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Agitation	Psychiatric disorders	MedDRA Version 24.1	Systematic Assessment	EG0001 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Delusion	Psychiatric disorders	MedDRA Version 24.1	Systematic Assessment	EG0001 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Hallucination	Psychiatric disorders	MedDRA Version 24.1	Systematic Assessment	EG0001 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0020 affected10 at risk EG003
Restlessness	Psychiatric disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0011 affected11 at risk EG0021 affected10 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA Version 24.1	Systematic Assessment	EG0000 affected10 at risk EG0010 affected11 at risk EG0020 affected10 at risk EG003

ID	Term
D020961	Lewy Body Disease
D010300	Parkinson Disease

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D003704	Dementia
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DLB Without Amyloid Copathology	Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.	1	10	1	10	5	10
EG001	DLB With Amyloid Copathology	Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.	0	11	0	11	4	11
EG002	PDD Without Amyloid Copathology	Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.	0	10	0	10	3	10
EG003	PDD With Amyloid Copathology	Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.	0	3	0	3	2	3