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

NCT03467152 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: E2027-G000-2012017-003728-64
• Study Type: interventional
• Target: 326
• Locations: 7 countries
• Sites: 74

Brief 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.

Conditions

Dementia With Lewy Bodies

Keywords

Irsenontrine; Montreal Cognitive Assessment; Neuropsychiatric Inventory; Mini-Mental State Examination; Cognitive Fluctuation Inventory

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at Week 12 of Treatment

  The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.

  Baseline and Week 12

• Number of Participants Based on Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale at Week 12 of Treatment

  Number of participants are reported categorized in grades based on the CIBIC-Plus scale. The CIBIC-Plus scale is designed to measure various domains that describe participant function: general, mental/cognitive state, behavior, and activities of daily living. It is a semi-structured global rating derived from a comprehensive interview with the participant and caregiver or informant by an independent rater who has no access to the source data or other psychometric test scores conducted post-randomization as part of the protocol. The CIBIC-Plus was a 7-point scale and scores were: 1 (marked improvement), 2 (moderate improvement), 3 (minimal improvement), 4 (no change), 5 (minimal worsening), 6 (moderate worsening), and 7 (marked worsening). Higher values represent a worse outcome.

  Week 12

Secondary Outcomes (14)

• Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale at Week 12 of Treatment

  Week 12

• Mean Change From Baseline in the Cognitive Fluctuation Inventory (CFI) Score at Week 12 of Treatment

  Baseline and Week 12

• Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Total Score Week 12 of Treatment

  Baseline and Week 12

• Mean Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Total Score at Week 12 of Treatment

  Baseline and Week 12

• Change From Baseline in NPI-4 Subscore at Week 12

  Baseline and Week 12

Study Arms (2)

Irsenontrine

EXPERIMENTAL

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

Drug: Irsenontrine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Irsenontrine DRUG

Oral hypromellose capsules.

Also known as: E2027

Irsenontrine

Placebo DRUG

Oral hypromellose capsules.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (74)

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

Advanced Research Center Inc

Anaheim, California, 92805, United States

Location

Parkinsons and Movement Disorders Institute

Fountain Valley, California, 92708, United States

Location

Paradigm Clinical Research Centers, Inc

San Diego, California, 92117, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Miami Jewish Health-Clinical Research

Miami, Florida, 33137, United States

Location

Elias Research Associates (Allied Biomedical Research Institute)

Miami, Florida, 33155, United States

Location

Pharmax Research of South Florida; Elias Research Associates

Miami, Florida, 33175, United States

Location

Compass Research-Bioclinica

Orlando, Florida, 32806, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Advanced Research Consultants, Inc.

Palm Beach Gardens, Florida, 33410, United States

Location

Anchor Neuroscience

Pensacola, Florida, 32502, United States

Location

Compass Research-Bioclinica

The Villages, Florida, 32162, United States

Location

Indiana University, Dept of Neurology

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky, Dept of Neurology Sanders Brown Center on Aging

Lexington, Kentucky, 40504, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Neurological Associates of Albany, PC

Albany, New York, 12208, United States

Location

Columbia University

New York, New York, 10032, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic, Lou Ruvo Center for Brain Health at Lakewood Hospital

Lakewood, Ohio, 44107, United States

Location

Summit Research Network (Oregon) Inc.

Portland, Oregon, 97210, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Kerwin Research Center, LLC

Dallas, Texas, 75231-4350, United States

Location

University of Virginia Adult Neurology

Charlottesville, Virginia, 22903, United States

Location

CHRU Nancy- CMRR de lorraine Hôpital de Brabois-Service de Gériatrie

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

Centre de Recherche Clinique - Viellissement-Cerveau-Fragilite (CRC-VCF), Hopital des Charpennes

Lyon, Villeurbanne, 69100, France

Location

Centre Memoire du CHRU de Lille

Lille, 59037, France

Location

Hopital Neurologique de Lyon

Lyon, 69677, France

Location

University Hospital de la Timone

Marseille, 13385, France

Location

Centre d'Investigation Clinique (CIC) Hopitaux universitaires Strasbourg HOPITAL DE HAUTEPIERRE - BATIMENT AX5

Strasbourg, 67000, France

Location

Eisai Trial Site #3

Berlin, 12203, Germany

Location

Eisai Trial Site #1

Kassel, 34128, Germany

Location

Eisai Trial Site #2

Westerstede, 26655, Germany

Location

Universita Chieti, CeSI Met

Chieti, 66100, Italy

Location

Clinica Neurologica Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Eisai Trial Site #20

Chiba, Chiba, 263-0043, Japan

Location

Eisai Trial Site #17

Fukuoka, Fukuoka, 814-0180, Japan

Location

Eisai Trial Site #8

Fujioka-shi, Gunma, 375-0017, Japan

Location

Eisai Trial Site #12

Maebashi, Gunma, 371-8511, Japan

Location

Eisai Trial Site #14

Miyoshi-shi, Hiroshima, 728-0013, Japan

Location

Eisai Trial Site #4

Otake-shi, Hiroshima, 739-0651, Japan

Location

Eisai Trial Site #2

Himeji-shi, Hyōgo, 670-0981, Japan

Location

Eisai Trial Site #23

Yokohama, Kanagawa, 225-0013, Japan

Location

Eisai Trial Site #11

Kumamoto, Kumamoto, 860-8556, Japan

Location

Eisai Trial Site #5

Nishisonogigun, Nagasaki, 851-2103, Japan

Location

Eisai Trial Site #9

Nagaoka-shi, Niigata, 940-2302, Japan

Location

Eisai Trial Site #3

Kurashiki-shi, Okayama-ken, 710-0813, Japan

Location

Eisai Trial Site #1

Naniwa-ku, Osaka, 556-0017, Japan

Location

Eisai Trial Site #16

Sakai-ku, Sakai-shi, Osaka, 590-0018, Japan

Location

Eisai Trial Site #24

Suita-shi, Osaka, 565-0871, Japan

Location

Eisai Trial Site #13

Suita-shi, Osaka, 565-0874, Japan

Location

Eisai Trial Site #6

Kanzaki-gun, Saga-ken, 842-0192, Japan

Location

Eisai Trial Site #10

Bunkyo-ku, Tokyo, 113-0034, Japan

Location

Eisai Trial Site #22

Mitaka-shi, Tokyo, 181-0013, Japan

Location

Eisai Trial Site #18

Setagaya-Ku, Tokyo, 158-0098, Japan

Location

Eisai Trial Site #19

Yanai-shi, Yamaguchi, 742-1352, Japan

Location

Eisai Trial Site #25

Hiroshima, 732-0066, Japan

Location

Eisai Trial Site #21

Osaka, 550-0012, Japan

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Institut Internacional de Neurociències Aplicades

Barcelona, 08006, Spain

Location

Fundacio ACE

Barcelona, 08228, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08235, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Dementia Research Unit

Crowborough, East Sussex, TN6 1HB, United Kingdom

Location

Memory Assessment and Research Centre, Moorgreen Hospital

Southampton, Hampshire, S030 3JB, United Kingdom

Location

Clinical Research Centre (CRC)

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

West London Mental Health Trust

Isleworth, TW7 6FY, United Kingdom

Location

Kings College

London, SE5 8AF, United Kingdom

Location

Cognition Health

London, W1G 9JF, United Kingdom

Location

Manchester Mental Health and Social Care Trust

Manchester, M25 3BL, United Kingdom

Location

Newcastle General Hospital

Newcastle, NE45PL, United Kingdom

Location

MeSH Terms

Conditions

Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai, Inc.

esi_medinfo@eisai.com

+1-888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 15, 2018
• Study Start: May 4, 2018
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: August 1, 2022
• Results First Posted: August 1, 2022

Record last verified: 2022-07

Locations

DE (3); IT (2); US (25); JP (23); GB (9); ES (6); FR (6)