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)
PRESENCE
Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)
2 other identifiers
interventional
344
3 countries
77
Brief Summary
A randomized placebo-controlled trial to evaluate the safety and efficacy of three doses of study drug LY3154207 treated for 12 weeks in participants with mild-to-moderate dementia associated with LBD (PDD or DLB).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2017
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2017
CompletedFirst Posted
Study publicly available on registry
October 10, 2017
CompletedStudy Start
First participant enrolled
November 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2020
CompletedResults Posted
Study results publicly available
July 23, 2021
CompletedJuly 23, 2021
July 1, 2021
2.7 years
October 4, 2017
July 2, 2021
July 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)
The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval.
Baseline, Week 12
Secondary Outcomes (19)
Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score
Baseline, Week 12
Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score
Baseline, Week 12
Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Baseline, Week 12
Change From Screening in the Montreal Cognitive Assessment (MoCA) Score
Screening (Baseline), Week 12
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score and Individual Item Scores
Baseline, Week 12
- +14 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants received placebo administered orally once a day (QD).
10 milligram (mg) LY3154207
EXPERIMENTALParticipants received 10 mg LY3154207 administered orally QD.
30 mg LY3154207
EXPERIMENTALParticipants received 30 mg LY3154207 administered orally QD.
75 mg LY3154207
EXPERIMENTALParticipants received 75 mg LY3154207 administered orally QD.
Interventions
Eligibility Criteria
You may qualify if:
- Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment.
- Meet diagnostic criteria for PD per MDS criteria or DLB per 4th Consensus Report of the DLB Consortium.
- Have a score on the MoCA of 10 - 23.
- Are Modified Hoehn and Yahr Stages 0 - 4.
- Have a blood pressure (BP) or pulse rate at screening and randomization, as determined by three sequential BP/pulse rate measurements in a seated position:
- Participants \<60 years old:
- A mean systolic BP less than or equal to 140 millimeters of mercury (mmHg), a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal 90 beats/minute in a seated position.
- Each of the 3 systolic BP measurement must be less than 180 mmHg
- Participants ≥60 years old:
- A mean systolic BP less than or equal to 150 mmHg, a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal to 90 beats/min in a seated position.
- Each of the 3 systolic BP measurement must be less than 180 mmHg
- If on anti-parkinsonian agents, participants must be on stable dosage for at least 3 weeks prior to screening, and should remain on stable doses during the course of the study.
- If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
- If on antidepressant medications, participants must be on stable dosage for at least 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
- If on clozapine, quetiapine, and pimavanserin to address drug induced or disease related psychosis, participants must be on stable dosage for 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
- +3 more criteria
You may not qualify if:
- Are women of childbearing potential.
- Have significant central nervous system or psychiatric disease, other than PD or DLB, that in the investigator's opinion may affect cognition or the ability to complete the study.
- Have a history in the last 6 months of transient ischemic attacks or ischemic stroke.
- Have a history of intra cerebral hemorrhage due to hypertension.
- Have a history of hypertensive encephalopathy.
- Have atypical or secondary parkinsonism due to drugs (e.g., antipsychotics) or disease (such as progressive supranuclear palsy, essential tremor, multiple system atrophy (e.g. striatonigral degeneration, olivopontocerebellar atrophy), or postencephalitic parkinsonism).
- Have a current implantable intracranial stimulator or history of intracranial ablation surgery (e.g., subthalamic, globus pallidus-internal segment \[GPi\]).
- Have a history of substance abuse within the past 1 year (drug categories defined by the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition \[DSM-5\], and/or substance dependence within the past 1 year, not including caffeine and nicotine.
- Have a serious or unstable medical illness, other than idiopathic LBD (PDD or DLB), including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality as determined by the investigator.
- Have a history in the last 6 months of exertional angina, unstable angina, myocardial infarction, and acute coronary syndrome.
- Have a history of heart failure of either New York Heart Association Class III or IV.
- A history of additional risk factors for Torsades de Pointes (TdP; \[e.g., chronic hypokalemia, family history of Long QT Syndrome\]).
- Participants with acute liver disease (e.g. acute viral hepatitis, alcoholic hepatitis); participants with a known chronic liver disease (e.g. hepatitis B, C, alcoholic liver disease, cirrhosis); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or higher than 2X upper limit of normal (ULN); total bilirubin (TBL) equal to or higher than 1.5X ULN; (except for participants with Gilbert's syndrome); or alkaline phosphatase (ALP) equal to or higher than 2X ULN.
- Participants have answered 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the Columbia Suicide Severity Rating Scale (C-SSRS)- Children's version, or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt).
- Have used antipsychotic medications, with the exception of clozapine, quetiapine, pimavanserin in the 6 months prior to screening and at any time during the course of the study.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Mayo Clinic of Scottsdale
Scottsdale, Arizona, 85259, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
University of Arizona Health Sciences
Tucson, Arizona, 85724, United States
Parkinson'S & Movement Disorder Institute
Fountain Valley, California, 92708, United States
University of CA, Irvine
Irvine, California, 92697, United States
Collaborative Neuroscience Network - CNS
Long Beach, California, 90806, United States
University of Southern California School of Medicine
Los Angeles, California, 90033, United States
Pacific Neuroscience Medical Group
Oxnard, California, 93030, United States
Stanford Neuroscience Health Center
Palo Alto, California, 94304, United States
SC3 Research Group Inc Pasadena
Pasadena, California, 91105, United States
SC3 Research Group Inc Reseda
Reseda, California, 91335, United States
University of California, Davis - Health Systems
Sacramento, California, 95817, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Denver Neurological Research
Denver, Colorado, 80210, United States
Rocky Mountain Movement Disorders Center
Englewood, Colorado, 80113, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Hartford Healthcare Chase Movement Disorders Center
Vernon, Connecticut, 06066, United States
Christiana Care Health Service
Newark, Delaware, 19713, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Visionary Investigators Network
Aventura, Florida, 33180, United States
Parkinson's Disease and Movement Disorders
Boca Raton, Florida, 33486, United States
Norman Fixel Institute for Neurological Diseases (FIND)
Gainesville, Florida, 32608, United States
ClinCloud, LLC
Maitland, Florida, 32751, United States
Visionary Investigators Network
Miami, Florida, 33133, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
VIN - Victor Faradji
Miami, Florida, 33176, United States
Collier Neurologic Specialists
Naples, Florida, 34105, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Compass Research
Orlando, Florida, 32806, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Visionary Investigators Network -VIN-Margarita Almeida
Pembroke Pines, Florida, 33026, United States
Axiom Research
Tampa, Florida, 33609, United States
Emory University
Atlanta, Georgia, 30329, United States
Atlanta Center of Medical Research
Atlanta, Georgia, 30331, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, 46256, United States
University of Kansas School of Medicine
Kansas City, Kansas, 66160, United States
Maine Neurology
Scarborough, Maine, 04074, United States
New England Neurological Associates, PC
Methuen, Massachusetts, 01844, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
QUEST Research Institute
Farmington Hills, Michigan, 48334, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Cleveland Clinic of Las Vegas
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
The Cognitive and Research Center of NJ
Springfield, New Jersey, 07081, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Dent Neurological Institute
Amherst, New York, 14226, United States
Alzheimer's Disease and Memory Disorders Center
Buffalo, New York, 14203, United States
Adirondack Medical Research
Glens Falls, New York, 12801, United States
Parker Jewish Insititue for Heatlh Care and Rehabilition
New Hyde Park, New York, 11040, United States
NYU Langone
New York, New York, 10016, United States
Carolinas Healthcare System
Charlotte, North Carolina, 28207, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Penn State Univ. Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Neurology, PA
Dallas, Texas, 75214, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75243, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist Research Ins
Houston, Texas, 77030, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007-4209, United States
Evergreen Professional Plaza
Kirkland, Washington, 98034, United States
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, 53705, United States
Toronto Memory Program
Toronto, Ontario, M3B 2S7, Canada
Ottawa Hospital Research Institute
Ottawa, K1Y 4E9, Canada
Cortex, PSC
Las Piedras, PR, 00771, Puerto Rico
Instituto de Neurologia Dra. Ivonne Fraga
San Juan, PR, 00918, Puerto Rico
University of Puerto Rico
San Juan, PR, 00936, Puerto Rico
Santa Cruz Behavioral PSC
Bayamón, 00961-6911, Puerto Rico
Related Publications (2)
Chen C, Kowahl NR, Rainaldi E, Burq M, Munsie LM, Battioui C, Wang J, Biglan K, Marks WJ Jr, Kapur R. Wrist-worn sensor-based measurements for drug effect detection with small samples in people with Lewy Body Dementia. Parkinsonism Relat Disord. 2023 Apr;109:105355. doi: 10.1016/j.parkreldis.2023.105355. Epub 2023 Mar 4.
PMID: 36905719DERIVEDWilbraham D, Biglan KM, Svensson KA, Tsai M, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator (D1PAM), in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Apr;10(4):393-403. doi: 10.1002/cpdd.874. Epub 2020 Oct 7.
PMID: 33029934DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2017
First Posted
October 10, 2017
Study Start
November 9, 2017
Primary Completion
July 10, 2020
Study Completion
July 10, 2020
Last Updated
July 23, 2021
Results First Posted
July 23, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.