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

Eisai

Status and phase: Completed; Phase 2

Conditions: Dementia With Lewy Bodies

Treatments: Drug: Irsenontrine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03467152

2017-003728-64 (EudraCT Number)

E2027-G000-201

Details and patient eligibility

About

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.

Enrollment: 326 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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326 participants in 2 patient groups, including a placebo group

Irsenontrine

Experimental group

Description:

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

Treatment:

Drug: Irsenontrine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo