Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies
NCT ID: NCT03467152
Last Updated: 2022-08-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
326 participants
INTERVENTIONAL
2018-05-04
2020-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
NCT01278407
A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology
NCT04764669
A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)
NCT03305809
A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
NCT00598650
A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
NCT00543855
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Irsenontrine
Participants will be randomized to receive a 50 milligram (mg) once daily oral dose of Irsenontrine for 12 weeks.
Irsenontrine
Oral hypromellose capsules.
Placebo
Participants will be randomized to receive a 50 mg once daily oral dose of Irsenontrine-matched placebo for 12 weeks.
Placebo
Oral hypromellose capsules.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Irsenontrine
Oral hypromellose capsules.
Placebo
Oral hypromellose capsules.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
50 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eisai Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banner Sun Health Research Institute
Sun City, Arizona, United States
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
CHRU Nancy- CMRR de lorraine Hôpital de Brabois-Service de Gériatrie
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Centre de Recherche Clinique - Viellissement-Cerveau-Fragilite (CRC-VCF), Hopital des Charpennes
Lyon, Villeurbanne, France
Centre Memoire du CHRU de Lille
Lille, , France
Hopital Neurologique de Lyon
Lyon, , France
University Hospital de la Timone
Marseille, , France
Centre d'Investigation Clinique (CIC) Hopitaux universitaires Strasbourg HOPITAL DE HAUTEPIERRE - BATIMENT AX5
Strasbourg, , France
Eisai Trial Site #3
Berlin, , Germany
Eisai Trial Site #1
Kassel, , Germany
Eisai Trial Site #2
Westerstede, , Germany
Universita Chieti, CeSI Met
Chieti, , Italy
Clinica Neurologica Azienda Ospedaliera di Padova
Padua, , Italy
Eisai Trial Site #20
Chiba, Chiba, Japan
Eisai Trial Site #17
Fukuoka, Fukuoka, Japan
Eisai Trial Site #8
Fujioka-shi, Gunma, Japan
Eisai Trial Site #12
Maebashi, Gunma, Japan
Eisai Trial Site #14
Miyoshi-shi, Hiroshima, Japan
Eisai Trial Site #4
Otake-shi, Hiroshima, Japan
Eisai Trial Site #2
Himeji-shi, Hyōgo, Japan
Eisai Trial Site #23
Yokohama, Kanagawa, Japan
Eisai Trial Site #11
Kumamoto, Kumamoto, Japan
Eisai Trial Site #5
Nishisonogigun, Nagasaki, Japan
Eisai Trial Site #9
Nagaoka-shi, Niigata, Japan
Eisai Trial Site #3
Kurashiki-shi, Okayama-ken, Japan
Eisai Trial Site #1
Naniwa-ku, Osaka, Japan
Eisai Trial Site #16
Sakai-ku, Sakai-shi, Osaka, Japan
Eisai Trial Site #24
Suita-shi, Osaka, Japan
Eisai Trial Site #13
Suita-shi, Osaka, Japan
Eisai Trial Site #6
Kanzaki-gun, Saga-ken, Japan
Eisai Trial Site #10
Bunkyo-ku, Tokyo, Japan
Eisai Trial Site #22
Mitaka-shi, Tokyo, Japan
Eisai Trial Site #18
Setagaya-Ku, Tokyo, Japan
Eisai Trial Site #19
Yanai-shi, Yamaguchi, Japan
Eisai Trial Site #25
Hiroshima, , Japan
Eisai Trial Site #21
Osaka, , Japan
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
Institut Internacional de Neurociències Aplicades
Barcelona, , Spain
Fundacio ACE
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Dementia Research Unit
Crowborough, East Sussex, United Kingdom
Memory Assessment and Research Centre, Moorgreen Hospital
Southampton, Hampshire, United Kingdom
Clinical Research Centre (CRC)
Dundee, Scotland, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
West London Mental Health Trust
Isleworth, , United Kingdom
Kings College
London, , United Kingdom
Cognition Health
London, , United Kingdom
Manchester Mental Health and Social Care Trust
Manchester, , United Kingdom
Newcastle General Hospital
Newcastle, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-003728-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E2027-G000-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.