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)

Lewy Body Dementia Clinical Trial

— PRESENCE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305809
• Other study ID #: 16261
• Secondary ID: I7S-MC-HBEH
• Status: Completed
• Phase: Phase 2
• Start date: November 9, 2017
• Est. completion date: July 10, 2020

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: July 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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:

1. 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.

2. Each of the 3 systolic BP measurement must be less than 180 mmHg

• Participants =60 years old:

1. 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.

2. 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.

• If on antihypertensive medications, participants must be on stable dosage for at least 3 weeks prior to screening.

• Men should use appropriate contraception.

• All participants must have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant to screening, baseline, day 7, day 42, day 84 and follow-up.

Exclusion Criteria:

• 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.

• Have used anticholinergics trihexyphenidyl and benztropine in the 4 weeks prior to screening and at any time during the course of the study.

• Have motor conditions for which the antiparkinsonian treatment is expected to change during the course of the study, as well as unpredictable motor fluctuations that in the investigator's opinion would interfere with administering assessments.

• Are taking any medications or food, herbal or dietary supplements that are inhibitors (e.g., ketoconazole, grapefruit juice), or strong/moderate inducers of cytochrome P450 3A4 (CYP3A4) (e.g., rifampicin) or are unable or unwilling to discontinue usage of them 4 weeks prior to first dose of study drug.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Lewy Body Dementia
• Lewy Body Disease
• Parkinson Disease

Intervention

Drug:
• LY3154207
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa
Canada	Toronto Memory Program	Toronto	Ontario
Puerto Rico	Santa Cruz Behavioral PSC	Bayamón
Puerto Rico	Cortex, PSC	Las Piedras
Puerto Rico	Instituto de Neurologia Dra. Ivonne Fraga	San Juan
Puerto Rico	University of Puerto Rico	San Juan
United States	Dent Neurological Institute	Amherst	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Atlanta Center of Medical Research	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	JEM Research Institute	Atlantis	Florida
United States	University of Colorado Hospital	Aurora	Colorado
United States	Visionary Investigators Network	Aventura	Florida
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorders	Boca Raton	Florida
United States	Alzheimer's Disease and Memory Disorders Center	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Healthcare System	Charlotte	North Carolina
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Neurology Consultants of Dallas, PA	Dallas	Texas
United States	Texas Neurology, PA	Dallas	Texas
United States	Denver Neurological Research	Denver	Colorado
United States	Rocky Mountain Movement Disorders Center	Englewood	Colorado
United States	QUEST Research Institute	Farmington Hills	Michigan
United States	Parkinson'S & Movement Disorder Institute	Fountain Valley	California
United States	Norman Fixel Institute for Neurological Diseases (FIND)	Gainesville	Florida
United States	Adirondack Medical Research	Glens Falls	New York
United States	Penn State Univ. Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist Research Ins	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Josephson Wallack Munshower Neurology	Indianapolis	Indiana
United States	University of CA, Irvine	Irvine	California
United States	University of Kansas School of Medicine	Kansas City	Kansas
United States	Evergreen Professional Plaza	Kirkland	Washington
United States	Cleveland Clinic of Las Vegas	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Collaborative Neuroscience Network - CNS	Long Beach	California
United States	University of Southern California School of Medicine	Los Angeles	California
United States	University of Wisconsin-Madison Hospital and Health Clinic	Madison	Wisconsin
United States	ClinCloud, LLC	Maitland	Florida
United States	New England Neurological Associates, PC	Methuen	Massachusetts
United States	Suncoast Research Group, LLC	Miami	Florida
United States	VIN - Victor Faradji	Miami	Florida
United States	Visionary Investigators Network	Miami	Florida
United States	Collier Neurologic Specialists	Naples	Florida
United States	Parker Jewish Insititue for Heatlh Care and Rehabilition	New Hyde Park	New York
United States	NYU Langone	New York	New York
United States	Christiana Care Health Service	Newark	Delaware
United States	Renstar Medical Research	Ocala	Florida
United States	Compass Research	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	Pacific Neuroscience Medical Group	Oxnard	California
United States	Stanford Neuroscience Health Center	Palo Alto	California
United States	SC3 Research Group Inc Pasadena	Pasadena	California
United States	Visionary Investigators Network -VIN-Margarita Almeida	Pembroke Pines	Florida
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	SC3 Research Group Inc Reseda	Reseda	California
United States	University of California, Davis - Health Systems	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Maine Neurology	Scarborough	Maine
United States	Mayo Clinic of Scottsdale	Scottsdale	Arizona
United States	The Cognitive and Research Center of NJ	Springfield	New Jersey
United States	New England Institute for Clinical Research	Stamford	Connecticut
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Axiom Research	Tampa	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	University of Arizona Health Sciences	Tucson	Arizona
United States	Hartford Healthcare Chase Movement Disorders Center	Vernon	Connecticut
United States	Sentara Neurology Specialists	Virginia Beach	Virginia
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Abington Neurological Associates	Willow Grove	Pennsylvania
United States	Central DuPage Hospital	Winfield	Illinois
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score	The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating. A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). 1= Very much better 2= Much better 3= A little better 4= Same 5= A little worse 6= Much worse 7= Very much worse. Least squares (LS) means were calculated using mixed model repeated measures adjusting for treatment + visit + treatment*visit + age*acheifl + age + concomitant use of acetylcholinesterase inhibitor (AChEI).	Baseline, Week 12
Secondary	Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score	The PoA is a composite score derived from the CDR-CCB that measures the intensity of concentration (ability to focus attention): the faster the responses, the more processes are being brought to bear upon the task. Power of attention is calculated from the sum of three cognitive function speed tests: simple reaction time, choice reaction time and the speed of detections in digit vigilance task. Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment Values are calculated by a computer and higher scores mean better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.	Baseline, Week 12
Secondary	Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)	The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.	Baseline, Week 12
Secondary	Change From Screening in the Montreal Cognitive Assessment (MoCA) Score	The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale. The MoCA is divided into 7 subscores (maximum possible subscore): visuospatial/executive (5 points), naming (3 points), memory (5 points for delayed recall), attention (6 points), language (3 points), abstraction (2 points) and orientation to time and place (6 points). A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.	Screening (Baseline), Week 12
Secondary	Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score and Individual Item Scores	The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD),as well as other related dementing disorders.It assesses 12 behavioral disturbances,namely delusions,hallucinations,depression/dysphoria,anxiety,agitation/aggression,elation/euphoria,disinhibition,irritability/lability,apathy, aberrant motor activity, night-time behavior disturbances,and appetite/eating abnormalities.The frequency scored from 0 (never) to 4 (very frequently).The Severity scored from 0 (none) to 3 (marked).The domain score is obtained by multiplying frequency and severity scores.The total NPI score is sum total of all of individual domain scores (0-144).Higher score indiciates more abnormal behaviors.LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.	Baseline, Week 12
Secondary	Change From Baseline in the Epworth Sleepiness Scale (ESS) Score	The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.	Baseline, Week 12
Secondary	Change From Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I-III)	Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for MDS-UPDRS MDS-UPDRS Part I (non-motor experiences of daily living) and Part II (motor experiences of daily living) scores, total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + levodopa equivalency dose (LED).	Baseline, Week 12
Secondary	Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score	The PDAQ-15 is a 15-item measure of instrumental activities of daily living (IADL) that are impacted by cognitive impairment in participants with parkinson's disease dementia (PDD). The PDAQ-15 is derived from the original 50-item scale, which has demonstrated test-retest reliability, construct validity, sensitivity, and specificity to Parkinson's disease (PD) cognitive impairment and the questionnaire is completed by the caregiver. The score range is 0 to 60, with higher scores indicating better function. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.	Baseline, Week 12
Secondary	Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score	The DKEFS verbal fluency category switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. Scales scores vary from 0 min to N/A max (no concrete maximum). Higher score = higher ability in language processing. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.	Baseline, Week 12
Secondary	Change in MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Exam) From Baseline to Week 12	Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for Part II total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + LED dose.	Baseline, Week 12
Secondary	Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 3	Number of participants who met the potentially clinically significant vital signs criteria at 3 consecutive time points at visit 3 were reported. In the event of an unacceptable rate of participants meeting day 1 stopping rules at other doses, adjustments to doses may be made for subsequently randomized participants at the discretion of the internal assessment committee (IAC).	Visit 3 (Day 1 stopping rules)
Secondary	Change From Baseline in Clinic Blood Pressure (BP) to 8 Hours Post Dose	Systolic and diastolic blood pressure obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.	Baseline, 8 Hours Post Dose
Secondary	Change From Baseline in Pulse Rate to 8 Hours Post Dose	Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.	Baseline, 8 Hours Post Dose
Secondary	Change From Baseline In-clinic BP to Week 12	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.	Baseline, Week 12
Secondary	Change From Baseline in Pulse Rate to Week 12	Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.	Baseline, Week 12
Secondary	Change in Home Blood Pressure Measurement (HBPM), for SBP, DBP From Baseline to Week 12	Systolic and diastolic blood pressure obtained from ABPM was evaluated. Participants followed a standardized measurement protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.	Baseline, Week 12
Secondary	Change in HBPM for Pulse Rate From Baseline to Week 12	Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to week 12 and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.	Baseline, Week 12
Secondary	Change From Baseline in the Physician Withdrawal Checklist (PWC)-20 Total Score From Week 12 to In-Clinic Follow-up Visit	The Penn PWC-20 is a 20-item checklist originally developed to assess the severity of withdrawal symptoms in anxiolytic medication discontinuation. To determine a change in the Intensity of Discontinuation symptoms, the PWC-20 administered by a trained clinician/rater to assess the intensity of discontinuation symptoms. The assessment has 20 items evaluated to detect withdrawal symptoms. Symptoms are rated on a scale of 0-3.; 0. Not present; Mild; Moderate; Severe Total scores range from 0 to 60 with higher scores indicating more severe symptoms.Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.	Week 12, Follow-up (2 Weeks after Week 12)
Secondary	Pharmacokinetics (PK): Steady-State Trough Plasma Concentrations of LY3154207	Trough measurements of LY3154207 concentration in plasma at Day 1, Day 7, Day 14, Day 42 and Day 84 was evaluated.	Day 1: 1-3 hours post-dose; Day 7, Day 14 and Day 42: post-dose; Day 84: pre-dose

External Links

•   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)