Phase 2 N=206 Randomized Quadruple-blind Treatment

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

Dementia With Lewy Bodies

Bottom Line

View on ClinicalTrials.gov: NCT03467152 ↗

Enrolled (actual)

206

Serious AEs

8.2%

Results posted

Aug 2022

Primary outcome: Primary: Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment — 13.9; 13.8; -0.6; -0.4 score on a scale — p=0.6909

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Irsenontrine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Eisai Inc.
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment	13.9; 13.8; -0.6; -0.4	0.6909
PRIMARY Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment	0; 0; 5; 3; 13; 18	0.8251
SECONDARY Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale at Week 12 of Treatment	1; 0; 3; 10; 20; 15	0.3003
SECONDARY Mean Change From Baseline in the Cognitive Fluctuation Inventory (CFI) Score at Week 12 of Treatment	3.4; 3.1; 0.1; 0.3	0.9198
SECONDARY Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Total Score Week 12 of Treatment	21.0; 21.1; -1.1; -1.7	0.2909
SECONDARY Mean Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Total Score at Week 12 of Treatment	17.6; 19.1; -0.2; -2.0	0.6127
SECONDARY Change From Baseline in NPI-4 Subscore at Week 12	8.2; 8.6; -0.4; -0.6	0.8780
SECONDARY Change From Baseline in NPI-10 Subscore at Week 12	13.5; 14.9; 0.6; -1.4	0.4090
SECONDARY Change From Baseline in NPI-D (Caregiver Distress) Total Score at Week 12	8.8; 9.4; -0.2; -0.6	0.8736
SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Serious TEAEs, Adverse Events (AEs) Resulting in Study Discontinuation	67; 70; 6; 2; 9; 7	—
SECONDARY Number of Participants With Orthostatic Hypotension	10; 2; 9; 7; 6; 11	—
SECONDARY Number of Participants With Orthostatic Tachycardia	1; 0	—
SECONDARY Number of Participants With Markedly Abnormal Laboratory Values	1; 0; 1; 0; 1; 0	—
SECONDARY Number of Participants With Abnormal Electrocardiogram (ECG) Findings	2; 0; 2; 0; 1; 1	—
SECONDARY Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)	0; 0; 0; 0; 0; 2	—
SECONDARY Change From Baseline in Total Score of Unified Parkinson's Disease Rating Scale Part III: Motor Examination (UPDRS-III)	31.3; 34.5; -1.2; 1.0	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03467152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.