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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dementia With Lewy Bodies

In brief

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.

Key facts

Study ID: NCT03467152
Run by: Eisai Inc.
People needed: 326
Starts: 2018-05-04
Expected to finish: 2020-04-15
Last updated by the study team: 2022-08-01

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Advanced Research Center Inc — Anaheim, California, United States
Parkinsons and Movement Disorders Institute — Fountain Valley, California, United States
Paradigm Clinical Research Centers, Inc — San Diego, California, United States
Syrentis Clinical Research — Santa Ana, California, United States
New England Institute for Clinical Research — Stamford, Connecticut, United States
Miami Jewish Health-Clinical Research — Miami, Florida, United States
Elias Research Associates (Allied Biomedical Research Institute) — Miami, Florida, United States
Pharmax Research of South Florida; Elias Research Associates — Miami, Florida, United States
Compass Research-Bioclinica — Orlando, Florida, United States
Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
Advanced Research Consultants, Inc. — Palm Beach Gardens, Florida, United States
Anchor Neuroscience — Pensacola, Florida, United States
Compass Research-Bioclinica — The Villages, Florida, United States
Indiana University, Dept of Neurology — Indianapolis, Indiana, United States
University of Kentucky, Dept of Neurology Sanders Brown Center on Aging — Lexington, Kentucky, United States
University of Michigan — Ann Arbor, Michigan, United States
Neurological Associates of Albany, PC — Albany, New York, United States
Columbia University — New York, New York, United States
PMG Research of Winston-Salem, LLC — Winston-Salem, North Carolina, United States
Cleveland Clinic, Lou Ruvo Center for Brain Health at Lakewood Hospital — Lakewood, Ohio, United States
Summit Research Network (Oregon) Inc. — Portland, Oregon, United States
New Orleans Center for Clinical Research — Knoxville, Tennessee, United States
Kerwin Research Center, LLC — Dallas, Texas, United States
University of Virginia Adult Neurology — Charlottesville, Virginia, United States
Banner Sun Health Research Institute — Sun City, Arizona, United States

Full record on ClinicalTrials.gov

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