Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Participants With Dementia With Lewy Bodies



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:3/30/2019
Start Date:May 4, 2018
End Date:March 11, 2020
Contact:Eisai Medical Information
Email:esi_medinfo@eisai.com
Phone:1-888-274-2378

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A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies

This study will be conducted to compare E2027 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.


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 ≥14 and ≤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.

- 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.
We found this trial at
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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Albany, New York 12208
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Anaheim, California 92805
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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6501 Baltimore National Pike
Catonsville, Maryland 21228
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4045 West Chandler Boulevard
Chandler, Arizona 85226
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Chapel Hill, North Carolina 27599
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Charlottesville, Virginia 22903
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8198 Walnut Hill Lane
Dallas, Texas 75231
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Fountain Valley, California 72708
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Indianapolis, Indiana 46202
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The Villages, Florida 32162
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54500
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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