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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 326
- 试验地点
- 70
- 主要终点
- Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 (>)
- •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.
研究组 & 干预措施
Irsenontrine
Participants will be randomized to receive a 50 milligram (mg) once daily oral dose of Irsenontrine for 12 weeks.
干预措施: Irsenontrine (Drug)
Placebo
Participants will be randomized to receive a 50 mg once daily oral dose of Irsenontrine-matched placebo for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment
时间窗: Baseline and Week 12
The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.
Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment
时间窗: Week 12
Number of participants are reported categorized in grades based on the CIBIC-Plus scale. The CIBIC-Plus scale is designed to measure various domains that describe participant function: general, mental/cognitive state, behavior, and activities of daily living. It is a semi-structured global rating derived from a comprehensive interview with the participant and caregiver or informant by an independent rater who has no access to the source data or other psychometric test scores conducted post-randomization as part of the protocol. The CIBIC-Plus was a 7-point scale and scores were: 1 (marked improvement), 2 (moderate improvement), 3 (minimal improvement), 4 (no change), 5 (minimal worsening), 6 (moderate worsening), and 7 (marked worsening). Higher values represent a worse outcome.
次要结局
- Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale at Week 12 of Treatment(Week 12)
- Mean Change From Baseline in the Cognitive Fluctuation Inventory (CFI) Score at Week 12 of Treatment(Baseline and Week 12)
- Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Total Score Week 12 of Treatment(Baseline and Week 12)
- Mean Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Total Score at Week 12 of Treatment(Baseline and Week 12)
- Change From Baseline in NPI-4 Subscore at Week 12(Baseline and Week 12)
- Change From Baseline in NPI-10 Subscore at Week 12(Baseline and Week 12)
- Change From Baseline in NPI-D (Caregiver Distress) Total Score at Week 12(Baseline and Week 12)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation(From first dose of study drug up to Week 16)
- Number of Participants With Orthostatic Tachycardia(From first dose of study drug up to Week 16)
- Number of Participants With Orthostatic Hypotension(Week 2, Week 4, Week 6, Week 9 and Week 12)
- Number of Participants With Markedly Abnormal Laboratory Values(From first dose of study drug up to Week 16)
- Number of Participants With Abnormal Electrocardiogram (ECG) Findings(From first dose of study drug up to Week 16)
- Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)(From first dose of study drug up to Week 16)
- Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III)(Baseline up to Week 16)