Status:
COMPLETED
Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies
Lead Sponsor:
Eisai Inc.
Conditions:
Dementia With Lewy Bodies
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
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 Impres...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2020
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT03467152
Start Date
May 4 2018
End Date
April 15 2020
Last Update
August 1 2022
Active Locations (74)
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1
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
2
Advanced Research Center Inc
Anaheim, California, United States, 92805
3
Parkinsons and Movement Disorders Institute
Fountain Valley, California, United States, 92708
4
Paradigm Clinical Research Centers, Inc
San Diego, California, United States, 92117