Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies
Condition: Dementia With Lewy Bodies
MeSH terms: Dementia; Lewy Body Disease
Intervention: Irsenontrine; Placebo
Intervention description: Oral hypromellose capsules.; Oral hypromellose capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 326.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Irsenontrine; Montreal Cognitive Assessment; Neuropsychiatric Inventory; Mini-Mental State Examination; Cognitive Fluctuation Inventory

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.
    

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.