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PRESENCE

CompletedPhase 2Results posted

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)

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)

Asset

Mevidalen

Listed sites

77

Recruiting sites

-

Enrollment

344

actual

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•MoCA 10-23•Study partner/caregiver required•History of intracranial hemorrhage excluded

Primary endpoint

•The Continuity of Attention (CoA) Composite Score of the Cognitive Drug

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID16261
Secondary IDI7S-MC-HBEHEli Lilly and Company
NCT IDNCT03305809

Timeline

Milestones

Study first posted2017-10-10actual
Study start2017-11-09actual
Primary completion2020-07-10actual
Study completion2020-07-10actual
Last update posted2021-07-23actual
Results first posted2021-07-23actual

Assets

Drug assets

Mevidalen

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age40 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (40)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
12
Other clinical outcomes
8
Global cognition
6
Safety / tolerability / PK
4
Memory
2
Executive function / language
2
Function / daily living
2
Behavior / neuropsychiatric
2
Caregiver / quality of life
2

Global cognition

6 endpoints
Secondary/protocol endpoint

Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Screening in the Montreal Cognitive Assessment (MoCA) Score

Time frame:Screening (Baseline), Week 12

Montreal Cognitive Assessment (MoCA)

descriptive

Secondary/registry result

Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=69 Participants64.1448.681
10 mg LY3154207n=73 Participants-6.5748.396
30 mg LY3154207n=65 Participants-42.8849.804
75 mg LY3154207n=54 Participants-59.5854.379
Mean Difference (Net)-70.7195% CI-205.53 - 64.11p0.303Mixed Models Analysis
Median Difference (Net)-107.0295% CI-244.09 - 30.06p0.125Mixed Models Analysis
Mean Difference (Net)-123.7295% CI-267.18 - 19.74p0.091Mixed Models Analysis
Secondary/registry result

Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=68 Participants-0.710.707
10 mg LY3154207n=73 Participants-1.110.691
30 mg LY3154207n=67 Participants-1.420.720
75 mg LY3154207n=54 Participants-1.590.799
Mean Difference (Net)-0.4095% CI-2.34 - 1.54p0.686Mixed Models Analysis
Mean Difference (Net)-0.7195% CI-2.70 - 1.28p0.485Mixed Models Analysis
Mean Difference (Net)-0.8995% CI-2.98 - 1.21p0.406Mixed Models Analysis
Secondary/registry result

Change From Screening in the Montreal Cognitive Assessment (MoCA) Score

Time frame:Screening (Baseline), Week 12

Montreal Cognitive Assessment (MoCA)

descriptive

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=71 Participants0.900.432
10 mg LY3154207n=76 Participants1.340.423
30 mg LY3154207n=68 Participants1.120.448
75 mg LY3154207n=55 Participants1.840.496
Mean Difference (Net)0.4495% CI-0.74 - 1.63p0.464Mixed Models Analysis
Mean Difference (Net)0.2295% CI-1.00 - 1.45p0.720Mixed Models Analysis
Mean Difference (Net)0.9595% CI-0.34 - 2.24p0.149Mixed Models Analysis

Memory

2 endpoints
Primary/protocol endpoint

Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)

Time frame:Baseline, Week 12

change from baseline, improvement

Primary/registry result

Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleReported bounds
Placebon=69 Participants1.04--0.339 - 2.373
10 mg LY3154207n=74 Participants0.15--1.206 - 1.496
30 mg LY3154207n=65 Participants0.96--0.448 - 2.362
75 mg LY3154207n=54 Participants0.26--1.310 - 1.801
Posterior Mean Difference-0.8995% CI-2.776 - 0.969
Posterior Mean Difference-0.0895% CI-1.996 - 1.879
Posterior Mean Difference-0.7895% CI-2.873 - 1.277

Executive function / language

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=71 Participants-0.190.280
10 mg LY3154207n=76 Participants0.440.271
30 mg LY3154207n=66 Participants0.880.292
75 mg LY3154207n=53 Participants0.300.325
Mean Difference (Net)0.6395% CI-0.13 - 1.40p0.105Mixed Models Analysis
Mean Difference (Net)1.0795% CI0.27 - 1.87p0.009Mixed Models Analysis
Mean Difference (Net)0.4995% CI-0.35 - 1.33p0.253Mixed Models Analysis

Function / daily living

2 endpoints
Secondary/protocol endpoint

Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=73 Participants-0.320.976
10 mg LY3154207n=77 Participants0.230.961
30 mg LY3154207n=67 Participants2.091.018
75 mg LY3154207n=55 Participants1.241.128
Mean Difference (Net)0.5695% CI-2.13 - 3.24p0.683Mixed Models Analysis
Mean Difference (Net)2.4195% CI-0.37 - 5.19p0.089Mixed Models Analysis
Mean Difference (Net)1.5695% CI-1.37 - 4.49p0.294Mixed Models Analysis

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score and Individual Item Scores

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score and Individual Item Scores

Time frame:Baseline, Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
PlaceboTotal Scoren=73 Participants-1.620.868
Delusionsn=73 Participants0.130.124
Hallucinationsn=73 Participants-0.090.131
Agitation/Aggressionn=71 Participants0.040.130
Depression/Dysphorian=73 Participants-0.220.155
Anxietyn=73 Participants-0.150.141
Elation/Euphorian=73 Participants0.140.069
Apathy/Indifferencen=73 Participants-0.360.191
Disinhibitionn=73 Participants-0.130.082
Irritability/Labilityn=73 Participants-0.190.130
Aberrant Motor Behaviorn=73 Participants-0.130.106
Sleep/Nighttime Behavior Disordersn=73 Participants-0.190.287
Appetite/Eating Disordersn=73 Participants-0.370.270
10 mg LY3154207Total Scoren=77 Participants-2.240.852
Delusionsn=77 Participants-0.040.121
Hallucinationsn=77 Participants-0.110.128
Agitation/Aggressionn=77 Participants-0.060.126
Depression/Dysphorian=77 Participants-0.160.151
Anxietyn=77 Participants-0.150.138
Elation/Euphorian=77 Participants0.030.068
Apathy/Indifferencen=77 Participants-0.810.186
Disinhibitionn=77 Participants-0.110.080
Irritability/Labilityn=77 Participants-0.430.127
Aberrant Motor Behaviorn=77 Participants0.030.103
Sleep/Nighttime Behavior Disordersn=77 Participants0.000.278
Appetite/Eating Disordersn=77 Participants-0.470.263
30 mg LY3154207Total Scoren=65 Participants-3.320.920
Delusionsn=66 Participants-0.250.130
Hallucinationsn=66 Participants-0.440.137
Agitation/Aggressionn=66 Participants-0.020.135
Depression/Dysphorian=66 Participants-0.330.164
Anxietyn=65 Participants0.070.149
Elation/Euphorian=65 Participants0.000.074
Apathy/Indifferencen=65 Participants-0.680.202
Disinhibitionn=65 Participants0.210.087
Irritability/Labilityn=65 Participants-0.250.137
Aberrant Motor Behaviorn=65 Participants-0.230.112
Sleep/Nighttime Behavior Disordersn=66 Participants-0.580.302
Appetite/Eating Disordersn=66 Participants-0.800.284
75 mg LY3154207Total Scoren=55 Participants-2.371.005
Delusionsn=54 Participants0.020.144
Hallucinationsn=55 Participants-0.380.151
Agitation/Aggressionn=55 Participants-0.200.148
Depression/Dysphorian=55 Participants-0.350.179
Anxietyn=55 Participants-0.220.163
Elation/Euphorian=55 Participants0.060.080
Apathy/Indifferencen=55 Participants-0.550.220
Disinhibitionn=55 Participants-0.090.095
Irritability/Labilityn=55 Participants0.020.150
Aberrant Motor Behaviorn=55 Participants-0.090.122
Sleep/Nighttime Behavior Disordersn=55 Participants-0.300.329
Appetite/Eating Disordersn=55 Participants-0.270.311
Mean Difference (Net)-0.6295% CI-3.01 - 1.76p0.607Mixed Models Analysis

Total Score

Mean Difference (Net)-1.7095% CI-4.19 - 0.79p0.180Mixed Models Analysis

Total Score

Mean Difference (Net)-0.7595% CI-3.36 - 1.86p0.572Mixed Models Analysis

Total Score

Mean Difference (Net)-0.1795% CI-0.51 - 0.17p0.320Mixed Models Analysis

Delusions

Mean Difference (Net)-0.3895% CI-0.73 - -0.02p0.037Mixed Models Analysis

Delusions

Mean Difference (Net)-0.1195% CI-0.49 - 0.26p0.558Mixed Models Analysis

Delusions

Mean Difference (Net)-0.0295% CI-0.38 - 0.34p0.924Mixed Models Analysis

Hallucinations

Mean Difference (Net)-0.3695% CI-0.73 - 0.02p0.061Mixed Models Analysis

Hallucinations

Mean Difference (Net)-0.2995% CI-0.68 - 0.10p0.148Mixed Models Analysis

Hallucinations

Mean Difference (Net)-0.1195% CI-0.46 - 0.25p0.552Mixed Models Analysis

Agitation/Aggression

Mean Difference (Net)-0.0695% CI-0.43 - 0.31p0.735Mixed Models Analysis

Agitation/Aggression

Mean Difference (Net)-0.2495% CI-0.63 - 0.15p0.224Mixed Models Analysis

Agitation/Aggression

Mean Difference (Net)0.0695% CI-0.37 - 0.48p0.783Mixed Models Analysis

Depression/Dysphoria

Mean Difference (Net)-0.1195% CI-0.55 - 0.34p0.640Mixed Models Analysis

Depression/Dysphoria

Mean Difference (Net)-0.1395% CI-0.59 - 0.34p0.592Mixed Models Analysis

Depression/Dysphoria

Mean Difference (Net)0.0095% CI-0.39 - 0.39p0.993Mixed Models Analysis

Anxiety

Mean Difference (Net)0.2295% CI-0.19 - 0.62p0.290Mixed Models Analysis

Anxiety

Mean Difference (Net)-0.0895% CI-0.50 - 0.35p0.722Mixed Models Analysis

Anxiety

Mean Difference (Net)-0.1195% CI-0.30 - 0.08p0.246Mixed Models Analysis

Elation/Euphoria

Mean Difference (Net)-0.1495% CI-0.34 - 0.06p0.175Mixed Models Analysis

Elation/Euphoria

Mean Difference (Net)-0.0795% CI-0.28 - 0.13p0.482Mixed Models Analysis

Elation/Euphoria

Mean Difference (Net)-0.4595% CI-0.97 - 0.07p0.091Mixed Models Analysis

Apathy/Indifference

Mean Difference (Net)-0.3295% CI-0.87 - 0.23p0.248Mixed Models Analysis

Apathy/Indifference

Mean Difference (Net)-0.1995% CI-0.76 - 0.38p0.516Mixed Models Analysis

Apathy/Indifference

Mean Difference (Net)0.0295% CI-0.21 - 0.24p0.875Mixed Models Analysis

Disinhibition

Mean Difference (Net)0.3495% CI0.10 - 0.57p0.005Mixed Models Analysis

Disinhibition

Mean Difference (Net)0.0495% CI-0.21 - 0.28p0.761Mixed Models Analysis

Disinhibition

Mean Difference (Net)-0.2495% CI-0.60 - 0.12p0.183Mixed Models Analysis

Irritability/Lability

Mean Difference (Net)-0.0695% CI-0.43 - 0.31p0.765Mixed Models Analysis

Irritability/Lability

Mean Difference (Net)0.2195% CI-0.18 - 0.61p0.279Mixed Models Analysis

Irritability/Lability

Mean Difference (Net)0.1795% CI-0.12 - 0.46p0.252Mixed Models Analysis

Aberrant Motor Behavior

Mean Difference (Net)-0.1095% CI-0.40 - 0.20p0.526Mixed Models Analysis

Aberrant Motor Behavior

Mean Difference (Net)0.0495% CI-0.28 - 0.36p0.800Mixed Models Analysis

Aberrant Motor Behavior

Mean Difference (Net)0.2095% CI-0.59 - 0.98p0.623Mixed Models Analysis

Sleep/Nighttime Behavior Disorders

Mean Difference (Net)-0.3995% CI-1.21 - 0.44p0.354Mixed Models Analysis

Sleep/Nighttime Behavior Disorders

Mean Difference (Net)-0.1195% CI-0.97 - 0.75p0.809Mixed Models Analysis

Sleep/Nighttime Behavior Disorders

Mean Difference (Net)-0.1095% CI-0.84 - 0.64p0.790Mixed Models Analysis

Appetite/Eating Disorders

Mean Difference (Net)-0.4295% CI-1.20 - 0.35p0.280Mixed Models Analysis

Appetite/Eating Disorders

Mean Difference (Net)0.1195% CI-0.70 - 0.92p0.797Mixed Models Analysis

Appetite/Eating Disorders

Caregiver / quality of life

2 endpoints
Secondary/protocol endpoint

Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scaleStandard error
Placebon=73 Participants4.00.13
10 mg LY3154207n=77 Participants3.80.12
30 mg LY3154207n=69 Participants3.30.13
75 mg LY3154207n=55 Participants3.10.15
Mean Difference (Net)-0.295% CI-0.54 - 0.15p0.273Mixed Models Analysis
Mean Difference (Net)-0.795% CI-1.02 - -0.30p<0.001Mixed Models Analysis
Mean Difference (Net)-0.995% CI-1.29 - -0.53p< 0.001Mixed Models Analysis

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 3

Time frame:Visit 3 (Day 1 stopping rules)

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Steady-State Trough Plasma Concentrations of LY3154207

Time frame:Day 1: 1-3 hours post-dose; Day 7, Day 14 and Day 42: post-dose; Day 84: pre-dose

concentration, descriptive

Secondary/registry result

Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 3

Time frame:Visit 3 (Day 1 stopping rules)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebon=86 Participants0-
10 mg LY3154207n=86 Participants0-
30 mg LY3154207n=65 Participants1-
75 mg LY3154207n=87 Participants1-
Secondary/registry result

Pharmacokinetics (PK): Steady-State Trough Plasma Concentrations of LY3154207

Time frame:Day 1: 1-3 hours post-dose; Day 7, Day 14 and Day 42: post-dose; Day 84: pre-dose

concentration, descriptive

Posted result

GroupValue (mean), nanogram per milliliter (ng/mL)Standard deviation
10 mg LY3154207Day 1n=86 Participants34.9528.82
Day 7n=80 Participants50.5338.20
Day 14n=81 Participants45.8533.61
Day 42n=74 Participants44.2533.93
Day 84n=68 Participants25.0130.43
30 mg LY3154207Day 1n=77 Participants89.3688.03
Day 7n=77 Participants123.61100.89
Day 14n=71 Participants129.2489.24
Day 42n=66 Participants149.22122.01
Day 84n=63 Participants59.3958.20
75 mg LY3154207Day 1n=81 Participants223.30208.63
Day 7n=70 Participants297.35242.47
Day 14n=69 Participants321.65253.11
Day 42n=61 Participants333.40257.74
Day 84n=56 Participants126.53197.67

Other clinical outcomes

8 endpoints
Secondary/protocol endpoint

Change From Baseline in the Epworth Sleepiness Scale (ESS) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Clinic Blood Pressure (BP) to 8 Hours Post Dose

Time frame:Baseline, 8 Hours Post Dose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline In-clinic BP to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Home Blood Pressure Measurement (HBPM), for SBP, DBP From Baseline to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Epworth Sleepiness Scale (ESS) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=73 Participants-0.330.437
10 mg LY3154207n=77 Participants-1.040.426
30 mg LY3154207n=67 Participants-1.210.452
75 mg LY3154207n=55 Participants-1.920.500
Mean Difference (Net)-0.7195% CI-1.91 - 0.49p0.247Mixed Models Analysis
Mean Difference (Net)-0.8895% CI-2.12 - 0.36p0.164Mixed Models Analysis
Mean Difference (Net)-1.5995% CI-2.90 - -0.29p0.017Mixed Models Analysis
Secondary/registry result

Change From Baseline in Clinic Blood Pressure (BP) to 8 Hours Post Dose

Time frame:Baseline, 8 Hours Post Dose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), millimeter of mercury (mmHg)Standard error
PlaceboSitting Systolic Blood Pressuren=81 Participants9.81.90
Sitting Diastolic Blood Pressuren=81 Participants4.60.99
10 mg LY3154207Sitting Systolic Blood Pressuren=82 Participants10.11.89
Sitting Diastolic Blood Pressuren=82 Participants4.90.98
30 mg LY3154207Sitting Systolic Blood Pressuren=79 Participants10.41.92
Sitting Diastolic Blood Pressuren=79 Participants5.51.00
75 mg LY3154207Sitting Systolic Blood Pressuren=85 Participants19.21.87
Sitting Diastolic Blood Pressuren=85 Participants8.10.97
Mean Difference (Net)0.395% CI-4.92 - 5.61p0.898Mixed Models Analysis

Sitting Systolic Blood Pressure

Mean Difference (Net)0.695% CI-4.71 - 5.94p0.821Mixed Models Analysis

Sitting Systolic Blood Pressure

Mean Difference (Net)9.495% CI4.11 - 14.61p<0.001Mixed Models Analysis

Sitting Systolic Blood Pressure

Mean Difference (Net)0.395% CI-2.40 - 3.08p0.805Mixed Models Analysis

Sitting Diastolic Blood Pressure

Mean Difference (Net)0.995% CI-1.85 - 3.69p0.513Mixed Models Analysis

Sitting Diastolic Blood Pressure

Mean Difference (Net)3.695% CI0.83 - 6.28p0.011Mixed Models Analysis

Sitting Diastolic Blood Pressure

Secondary/registry result

Change From Baseline In-clinic BP to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), millimeters of mercury (mmHg)Standard error
PlaceboSitting Systolic Blood Pressuren=74 Participants-1.21.22
Sitting Diastolic Blood Pressuren=74 Participants-0.90.71
10 mg LY3154207Sitting Systolic Blood Pressuren=77 Participants0.51.19
Sitting Diastolic Blood Pressuren=77 Participants-1.00.70
30 mg LY3154207Sitting Systolic Blood Pressuren=65 Participants0.11.29
Sitting Diastolic Blood Pressuren=65 Participants-0.20.75
75 mg LY3154207Sitting Systolic Blood Pressuren=56 Participants3.01.38
Sitting Diastolic Blood Pressuren=56 Participants0.30.80
Mean Difference (Net)1.695% CI-1.72 - 4.99p0.339Mixed Models Analysis

Sitting Systolic Blood Pressure

Mean Difference (Net)1.295% CI-2.26 - 4.73p0.486Mixed Models Analysis

Sitting Systolic Blood Pressure

Mean Difference (Net)4.295% CI0.56 - 7.81p0.024Mixed Models Analysis

Sitting Systolic Blood Pressure

Mean Difference (Net)-0.195% CI-2.04 - 1.88p0.935Mixed Models Analysis

Sitting Diastolic Blood Pressure

Mean Difference (Net)0.795% CI-1.34 - 2.72p0.505Mixed Models Analysis

Sitting Diastolic Blood Pressure

Mean Difference (Net)1.2295% CI-0.91 - 3.30p0.266Mixed Models Analysis

Sitting Diastolic Blood Pressure

Secondary/registry result

Change in Home Blood Pressure Measurement (HBPM), for SBP, DBP From Baseline to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mmHgStandard error
PlaceboSitting Systolic Blood Pressuren=48 Participants-1.12.52
Sitting Diastolic Blood Pressuren=48 Participants1.51.50
10 mg LY3154207Sitting Systolic Blood Pressuren=51 Participants-8.22.40
Sitting Diastolic Blood Pressuren=51 Participants-2.81.45
30 mg LY3154207Sitting Systolic Blood Pressuren=41 Participants2.02.58
Sitting Diastolic Blood Pressuren=41 Participants1.01.55
75 mg LY3154207Sitting Systolic Blood Pressuren=41 Participants-2.22.62
Sitting Diastolic Blood Pressuren=41 Participants-0.81.58
Mean Difference (Net)-7.095% CI-13.92 - -0.15p0.045Mixed Models Analysis

Sitting Systolic Blood Pressure

Mean Difference (Net)3.195% CI-4.05 - 10.32p0.390Mixed Models Analysis

Sitting Systolic Blood Pressure

Mean Difference (Net)-1.195% CI-8.32 - 6.16p0.768Mixed Models Analysis

Sitting Systolic Blood Pressure

Mean Difference (Net)-4.395% CI-8.48 - -0.17p0.041Mixed Models Analysis

Sitting Diastolic Blood Pressure

Mean Difference (Net)-0.595% CI-4.81 - 3.72p0.802Mixed Models Analysis

Sitting Diastolic Blood Pressure

Mean Difference (Net)-2.495% CI-6.67 - 1.97p0.284Mixed Models Analysis

Sitting Diastolic Blood Pressure

Other (unclassified)

12 endpoints
Secondary/protocol endpoint/low confidence

Change From Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I-III)

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Exam) From Baseline to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Pulse Rate to 8 Hours Post Dose

Time frame:Baseline, 8 Hours Post Dose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Pulse Rate to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in HBPM for Pulse Rate From Baseline to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in the Physician Withdrawal Checklist (PWC)-20 Total Score From Week 12 to In-Clinic Follow-up Visit

Time frame:Week 12, Follow-up (2 Weeks after Week 12)

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I-III)

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
Placebon=56 Participants-0.182.112
10 mg LY3154207n=70 Participants-6.581.941
30 mg LY3154207n=61 Participants-7.562.084
75 mg LY3154207n=50 Participants-10.772.287
Mean Difference (Net)-6.4195% CI-12.04 - -0.77p0.026Mixed Models Analysis
Mean Difference (Net)-7.3995% CI-13.24 - -1.53p0.014Mixed Models Analysis
Mean Difference (Net)-10.6095% CI-16.72 - -4.48p<0.001Mixed Models Analysis
Secondary/registry result/low confidence

Change in MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Exam) From Baseline to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
PlaceboMotor Experiences of Daily Livingn=73 Participants0.280.656
Motor Examn=57 Participants-0.121.343
10 mg LY3154207Motor Experiences of Daily Livingn=77 Participants-1.450.649
Motor Examn=71 Participants-3.391.240
30 mg LY3154207Motor Experiences of Daily Livingn=69 Participants-2.080.700
Motor Examn=61 Participants-3.401.331
75 mg LY3154207Motor Experiences of Daily Livingn=53 Participants-3.220.779
Motor Examn=52 Participants-4.351.434
Mean Difference (Net)-1.7495% CI-3.56 - 0.08p0.061Mixed Models Analysis

Motor Experiences of Daily Living

Mean Difference (Net)-2.3795% CI-4.26 - -0.47p0.014Mixed Models Analysis

Motor Experiences of Daily Living

Mean Difference (Net)-3.5095% CI-5.50 - -1.51p<0.001Mixed Models Analysis

Motor Experiences of Daily Living

Mean Difference (Net)-3.2795% CI-6.86 - 0.32p0.074Mixed Models Analysis

Motor Exam

Mean Difference (Net)-3.2795% CI-7.00 - 0.45p0.085Mixed Models Analysis

Motor Exam

Mean Difference (Net)-4.2395% CI-8.09 - -0.37p0.032Mixed Models Analysis

Motor Exam

Secondary/registry result/low confidence

Change From Baseline in Pulse Rate to 8 Hours Post Dose

Time frame:Baseline, 8 Hours Post Dose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), beats/minStandard error
Placebon=81 Participants-2.20.94
10 mg LY3154207n=82 Participants0.20.95
30 mg LY3154207n=79 Participants1.30.95
75 mg LY3154207n=85 Participants6.40.93
Mean Difference (Net)2.595% CI-0.16 - 5.08p0.065Mixed Models Analysis
Mean Difference (Net)3.695% CI0.93 - 6.21p0.008Mixed Models Analysis
Mean Difference (Net)8.795% CI6.06 - 11.27p<0.001Mixed Models Analysis
Secondary/registry result/low confidence

Change From Baseline in Pulse Rate to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), beats/minStandard error
Placebon=74 Participants-0.20.67
10 mg LY3154207n=77 Participants0.30.66
30 mg LY3154207n=65 Participants1.50.71
75 mg LY3154207n=56 Participants2.60.75
Mean Difference (Net)0.695% CI-1.28 - 2.41p0.550Mixed Models Analysis
Mean Difference (Net)1.895% CI-0.14 - 3.68p0.069Mixed Models Analysis
Mean Difference (Net)2.995% CI0.89 - 4.83p0.005Mixed Models Analysis
Secondary/registry result/low confidence

Change in HBPM for Pulse Rate From Baseline to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), beats/minStandard error
Placebon=48 Participants1.41.52
10 mg LY3154207n=51 Participants1.41.47
30 mg LY3154207n=41 Participants0.71.59
75 mg LY3154207n=41 Participants0.81.62
Mean Difference (Net)0.095% CI-4.17 - 4.19p0.996Mixed Models Analysis
Mean Difference (Net)-0.795% CI-4.99 - 3.69p0.767Mixed Models Analysis
Mean Difference (Net)-0.695% CI-4.96 - 3.79p0.791Mixed Models Analysis
Secondary/registry result/low confidence

Change From Baseline in the Physician Withdrawal Checklist (PWC)-20 Total Score From Week 12 to In-Clinic Follow-up Visit

Time frame:Week 12, Follow-up (2 Weeks after Week 12)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Units on a scaleStandard error
PlaceboWeek 12n=35 Participants-1.510.670
Follow-upn=35 Participants-1.270.844
10 mg LY3154207Week 12n=33 Participants-0.530.690
Follow-upn=33 Participants0.120.877
30 mg LY3154207Week 12n=32 Participants-0.470.701
Follow-upn=32 Participants0.130.904
75 mg LY3154207Week 12n=24 Participants0.050.811
Follow-upn=24 Participants3.321.040
Mean Difference (Net)0.9895% CI-0.93 - 2.88p0.312ANCOVA

Week 12

Mean Difference (Net)1.0395% CI-0.89 - 2.95p0.289ANCOVA

Week 12

Mean Difference (Net)1.5695% CI-0.53 - 3.65p0.141ANCOVA

Week 12

Mean Difference (Net)0.0695% CI-1.89 - 2.01p0.954ANCOVA

Week 12

Mean Difference (Net)0.5995% CI-1.53 - 2.70p0.584ANCOVA
Mean Difference (Net)0.5395% CI-1.59 - 2.65p0.623ANCOVA

Week 12

Mean Difference (Net)1.3995% CI-1.02 - 3.79p0.256ANCOVA

Follow-up

Mean Difference (Net)1.4195% CI-1.04 - 3.86p0.258ANCOVA

Follow-up

Mean Difference (Net)4.5995% CI1.93 - 7.25p<0.001ANCOVA

Follow-up

Mean Difference (Net)0.0295% CI-2.47 - 2.51p0.988ANCOVA

Follow-up

Mean Difference (Net)3.2095% CI0.51 - 5.90p0.020ANCOVA

Follow-up

Mean Difference (Net)3.1895% CI0.46 - 5.91p0.022ANCOVA

Follow-up

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.