search
Back to results

Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies

Primary Purpose

Dementia With Lewy Bodies

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Irsenontrine
Placebo
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia With Lewy Bodies focused on measuring Irsenontrine, Montreal Cognitive Assessment, Neuropsychiatric Inventory, Mini-Mental State Examination, Cognitive Fluctuation Inventory

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, age 50 to 85 years, inclusive at time of consent.
  • Meet criteria for probable dementia with Lewy bodies (DLB) (as defined by the 4th report of the DLB Consortium).
  • Mini-Mental State Examination greater than or equal to (≥)14 and less than or equal to (≤) 26 at Screening Visit.
  • Has experienced visual hallucinations during the past 4 weeks before Screening Visit.
  • If receiving acetylcholinesterase inhibitors (AChEI), 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.
  • 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. If a participant lacks capacity to consent in the investigator's opinion, the participant's assent should be obtained, as required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations). In countries where local laws, regulations, and customs do not permit participants who lack capacity to consent to participate in this study, they will not be enrolled.

Exclusion Criteria:

  • Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB, including any comorbidities detected by clinical assessment or magnetic resonance imaging (MRI).
  • History of transient ischemic attacks or stroke within 12 months of Screening.
  • Modified Hachinski Ischemic Scale greater than (>) 4.
  • Parkinsonian (extrapyramidal) features with Hoehn and Yahr stage 4 intravenous 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 score > 8.

Sites / Locations

  • Banner Sun Health Research Institute
  • Advanced Research Center Inc
  • Parkinsons and Movement Disorders Institute
  • Paradigm Clinical Research Centers, Inc
  • Syrentis Clinical Research
  • New England Institute for Clinical Research
  • Miami Jewish Health-Clinical Research
  • Elias Research Associates (Allied Biomedical Research Institute)
  • Pharmax Research of South Florida; Elias Research Associates
  • Compass Research-Bioclinica
  • Neurology Associates of Ormond Beach
  • Advanced Research Consultants, Inc.
  • Anchor Neuroscience
  • Compass Research-Bioclinica
  • Indiana University, Dept of Neurology
  • University of Kentucky, Dept of Neurology Sanders Brown Center on Aging
  • University of Michigan
  • Neurological Associates of Albany, PC
  • Columbia University
  • PMG Research of Winston-Salem, LLC
  • Cleveland Clinic, Lou Ruvo Center for Brain Health at Lakewood Hospital
  • Summit Research Network (Oregon) Inc.
  • New Orleans Center for Clinical Research
  • Kerwin Research Center, LLC
  • University of Virginia Adult Neurology
  • CHRU Nancy- CMRR de lorraine Hôpital de Brabois-Service de Gériatrie
  • Centre de Recherche Clinique - Viellissement-Cerveau-Fragilite (CRC-VCF), Hopital des Charpennes
  • Centre Memoire du CHRU de Lille
  • Hopital Neurologique de Lyon
  • University Hospital de la Timone
  • Centre d'Investigation Clinique (CIC) Hopitaux universitaires Strasbourg HOPITAL DE HAUTEPIERRE - BATIMENT AX5
  • Eisai Trial Site #3
  • Eisai Trial Site #1
  • Eisai Trial Site #2
  • Universita Chieti, CeSI Met
  • Clinica Neurologica Azienda Ospedaliera di Padova
  • Eisai Trial Site #20
  • Eisai Trial Site #17
  • Eisai Trial Site #8
  • Eisai Trial Site #12
  • Eisai Trial Site #14
  • Eisai Trial Site #4
  • Eisai Trial Site #2
  • Eisai Trial Site #23
  • Eisai Trial Site #11
  • Eisai Trial Site #5
  • Eisai Trial Site #9
  • Eisai Trial Site #3
  • Eisai Trial Site #1
  • Eisai Trial Site #16
  • Eisai Trial Site #24
  • Eisai Trial Site #13
  • Eisai Trial Site #6
  • Eisai Trial Site #10
  • Eisai Trial Site #22
  • Eisai Trial Site #18
  • Eisai Trial Site #19
  • Eisai Trial Site #25
  • Eisai Trial Site #21
  • Hospital Mutua de Terrassa
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Institut Internacional de Neurociències Aplicades
  • Fundacio ACE
  • Hospital Universitari Vall d'Hebron
  • Hospital General Universitario Gregorio Maranon
  • Dementia Research Unit
  • Memory Assessment and Research Centre, Moorgreen Hospital
  • Clinical Research Centre (CRC)
  • Queen Elizabeth University Hospital
  • West London Mental Health Trust
  • Kings College
  • Cognition Health
  • Manchester Mental Health and Social Care Trust
  • Newcastle General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Irsenontrine

Placebo

Arm Description

Participants will be randomized to receive a 50 milligram (mg) once daily oral dose of Irsenontrine for 12 weeks.

Participants will be randomized to receive a 50 mg once daily oral dose of Irsenontrine-matched placebo for 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment
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.
Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment
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 Outcome Measures

Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale at Week 12 of Treatment
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.
Mean Change From Baseline in the Cognitive Fluctuation Inventory (CFI) Score at Week 12 of Treatment
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.
Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Total Score Week 12 of Treatment
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.
Mean Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Total Score at Week 12 of Treatment
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.
Change From Baseline in NPI-4 Subscore at 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.
Change From Baseline in NPI-10 Subscore at 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.
Change From Baseline in NPI-D (Caregiver Distress) Total Score at 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.
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 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.
Number of Participants With Orthostatic Hypotension
Orthostatic hypotension was defined as drop in standing systolic blood pressure greater than or equal to (>=) 20 Millimeter of mercury (mmHg) compared to supine, or drop in standing diastolic blood pressure >=10 mmHg compared to supine.
Number of Participants With Orthostatic Tachycardia
Orthostatic tachycardia by numerical criteria was defined by the following numerical criteria: Standing heart rate (HR) increased by >30 beats/min compared to supine and absolute standing HR was >100 beats/min.
Number of Participants With Markedly Abnormal Laboratory Values
A laboratory value was determined to be a markedly abnormal value if the postbaseline common toxicity criteria grade increased from baseline and the post-baseline grade was greater than or equal to 2.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
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.
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.

Full Information

First Posted
March 9, 2018
Last Updated
July 29, 2022
Sponsor
Eisai Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03467152
Brief Title
Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies
Official Title
A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Lewy Bodies
Keywords
Irsenontrine, Montreal Cognitive Assessment, Neuropsychiatric Inventory, Mini-Mental State Examination, Cognitive Fluctuation Inventory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irsenontrine
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a 50 milligram (mg) once daily oral dose of Irsenontrine for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive a 50 mg once daily oral dose of Irsenontrine-matched placebo for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Irsenontrine
Other Intervention Name(s)
E2027
Intervention Description
Oral hypromellose capsules.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral hypromellose capsules.
Primary Outcome Measure Information:
Title
Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment
Description
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.
Time Frame
Baseline and Week 12
Title
Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale at Week 12 of Treatment
Description
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.
Time Frame
Week 12
Title
Mean Change From Baseline in the Cognitive Fluctuation Inventory (CFI) Score at Week 12 of Treatment
Description
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.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Total Score Week 12 of Treatment
Description
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.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Total Score at Week 12 of Treatment
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in NPI-4 Subscore at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in NPI-10 Subscore at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline in NPI-D (Caregiver Distress) Total Score at Week 12
Description
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.
Time Frame
Baseline and Week 12
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation
Description
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.
Time Frame
From first dose of study drug up to Week 16
Title
Number of Participants With Orthostatic Hypotension
Description
Orthostatic hypotension was defined as drop in standing systolic blood pressure greater than or equal to (>=) 20 Millimeter of mercury (mmHg) compared to supine, or drop in standing diastolic blood pressure >=10 mmHg compared to supine.
Time Frame
Week 2, Week 4, Week 6, Week 9 and Week 12
Title
Number of Participants With Orthostatic Tachycardia
Description
Orthostatic tachycardia by numerical criteria was defined by the following numerical criteria: Standing heart rate (HR) increased by >30 beats/min compared to supine and absolute standing HR was >100 beats/min.
Time Frame
From first dose of study drug up to Week 16
Title
Number of Participants With Markedly Abnormal Laboratory Values
Description
A laboratory value was determined to be a markedly abnormal value if the postbaseline common toxicity criteria grade increased from baseline and the post-baseline grade was greater than or equal to 2.
Time Frame
From first dose of study drug up to Week 16
Title
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Time Frame
From first dose of study drug up to Week 16
Title
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
From first dose of study drug up to Week 16
Title
Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III)
Description
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.
Time Frame
Baseline up to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age 50 to 85 years, inclusive at time of consent. Meet criteria for probable dementia with Lewy bodies (DLB) (as defined by the 4th report of the DLB Consortium). Mini-Mental State Examination greater than or equal to (≥)14 and less than or equal to (≤) 26 at Screening Visit. Has experienced visual hallucinations during the past 4 weeks before Screening Visit. If receiving acetylcholinesterase inhibitors (AChEI), 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. 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. If a participant lacks capacity to consent in the investigator's opinion, the participant's assent should be obtained, as required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations). In countries where local laws, regulations, and customs do not permit participants who lack capacity to consent to participate in this study, they will not be enrolled. Exclusion Criteria: Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB, including any comorbidities detected by clinical assessment or magnetic resonance imaging (MRI). History of transient ischemic attacks or stroke within 12 months of Screening. Modified Hachinski Ischemic Scale greater than (>) 4. Parkinsonian (extrapyramidal) features with Hoehn and Yahr stage 4 intravenous 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 score > 8.
Facility Information:
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Advanced Research Center Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Parkinsons and Movement Disorders Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Miami Jewish Health-Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Elias Research Associates (Allied Biomedical Research Institute)
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Pharmax Research of South Florida; Elias Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Compass Research-Bioclinica
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Advanced Research Consultants, Inc.
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Anchor Neuroscience
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
Compass Research-Bioclinica
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Indiana University, Dept of Neurology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky, Dept of Neurology Sanders Brown Center on Aging
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Neurological Associates of Albany, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic, Lou Ruvo Center for Brain Health at Lakewood Hospital
City
Lakewood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Summit Research Network (Oregon) Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Kerwin Research Center, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4350
Country
United States
Facility Name
University of Virginia Adult Neurology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
CHRU Nancy- CMRR de lorraine Hôpital de Brabois-Service de Gériatrie
City
Vandœuvre-lès-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
Centre de Recherche Clinique - Viellissement-Cerveau-Fragilite (CRC-VCF), Hopital des Charpennes
City
Lyon
State/Province
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Centre Memoire du CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Neurologique de Lyon
City
Lyon
ZIP/Postal Code
69677
Country
France
Facility Name
University Hospital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre d'Investigation Clinique (CIC) Hopitaux universitaires Strasbourg HOPITAL DE HAUTEPIERRE - BATIMENT AX5
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Eisai Trial Site #3
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Eisai Trial Site #1
City
Kassel
ZIP/Postal Code
34128
Country
Germany
Facility Name
Eisai Trial Site #2
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Universita Chieti, CeSI Met
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Clinica Neurologica Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Eisai Trial Site #20
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
263-0043
Country
Japan
Facility Name
Eisai Trial Site #17
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Eisai Trial Site #8
City
Fujioka-shi
State/Province
Gunma
ZIP/Postal Code
375-0017
Country
Japan
Facility Name
Eisai Trial Site #12
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Eisai Trial Site #14
City
Miyoshi-shi
State/Province
Hiroshima
ZIP/Postal Code
728-0013
Country
Japan
Facility Name
Eisai Trial Site #4
City
Otake-shi
State/Province
Hiroshima
ZIP/Postal Code
739-0651
Country
Japan
Facility Name
Eisai Trial Site #2
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
670-0981
Country
Japan
Facility Name
Eisai Trial Site #23
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
225-0013
Country
Japan
Facility Name
Eisai Trial Site #11
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Eisai Trial Site #5
City
Nishisonogigun
State/Province
Nagasaki
ZIP/Postal Code
851-2103
Country
Japan
Facility Name
Eisai Trial Site #9
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2302
Country
Japan
Facility Name
Eisai Trial Site #3
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
710-0813
Country
Japan
Facility Name
Eisai Trial Site #1
City
Naniwa-ku
State/Province
Osaka
ZIP/Postal Code
556-0017
Country
Japan
Facility Name
Eisai Trial Site #16
City
Sakai-ku, Sakai-shi
State/Province
Osaka
ZIP/Postal Code
590-0018
Country
Japan
Facility Name
Eisai Trial Site #24
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Eisai Trial Site #13
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0874
Country
Japan
Facility Name
Eisai Trial Site #6
City
Kanzaki-gun
State/Province
Saga
ZIP/Postal Code
842-0192
Country
Japan
Facility Name
Eisai Trial Site #10
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-0034
Country
Japan
Facility Name
Eisai Trial Site #22
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-0013
Country
Japan
Facility Name
Eisai Trial Site #18
City
Setagaya-Ku
State/Province
Tokyo
ZIP/Postal Code
158-0098
Country
Japan
Facility Name
Eisai Trial Site #19
City
Yanai-shi
State/Province
Yamaguchi
ZIP/Postal Code
742-1352
Country
Japan
Facility Name
Eisai Trial Site #25
City
Hiroshima
ZIP/Postal Code
732-0066
Country
Japan
Facility Name
Eisai Trial Site #21
City
Osaka
ZIP/Postal Code
550-0012
Country
Japan
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Institut Internacional de Neurociències Aplicades
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Fundacio ACE
City
Barcelona
ZIP/Postal Code
08228
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08235
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Dementia Research Unit
City
Crowborough
State/Province
East Sussex
ZIP/Postal Code
TN6 1HB
Country
United Kingdom
Facility Name
Memory Assessment and Research Centre, Moorgreen Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
S030 3JB
Country
United Kingdom
Facility Name
Clinical Research Centre (CRC)
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
West London Mental Health Trust
City
Isleworth
ZIP/Postal Code
TW7 6FY
Country
United Kingdom
Facility Name
Kings College
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Name
Cognition Health
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
Manchester Mental Health and Social Care Trust
City
Manchester
ZIP/Postal Code
M25 3BL
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle
ZIP/Postal Code
NE45PL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies

We'll reach out to this number within 24 hrs