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CompletedNCT03305809PRESENCEUpdated Jul 23, 2021Results 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)

A Phase 2 interventional study of LY3154207 and Placebo in Lewy Body Dementia, sponsored by Eli Lilly and Company. Completed at 77 sites in 3 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-07-23.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
344
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Lewy Body Dementia

Keywords

  • Parkinson Disease Dementia
  • Parkinson Disease
  • Dopamine
  • Cognition
  • Lewy Body Dementia
  • Dementia with Lewy Bodies
03

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
344 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Participants received placebo administered orally once a day (QD).

    Drug: Placebo

  • Experimental
    10 milligram (mg) LY3154207

    Participants received 10 mg LY3154207 administered orally QD.

    Drug: LY3154207

  • Experimental
    30 mg LY3154207

    Participants received 30 mg LY3154207 administered orally QD.

    Drug: LY3154207

  • Experimental
    75 mg LY3154207

    Participants received 75 mg LY3154207 administered orally QD.

    Drug: LY3154207

Interventions

  • DrugLY3154207

    Administered orally.

  • DrugPlacebo

    Administered orally.

05

What researchers measure

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.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. 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).

    Time frame: Baseline, Week 12

  2. 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.

    Time frame: Baseline, Week 12

  3. 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.

    Time frame: Baseline, Week 12

  4. 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.

    Time frame: Screening (Baseline), Week 12

  5. 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.

    Time frame: Baseline, Week 12

  6. 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.

    Time frame: Baseline, Week 12

  7. 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).

    Time frame: Baseline, Week 12

  8. 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.

    Time frame: Baseline, Week 12

  9. 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.

    Time frame: Baseline, Week 12

  10. 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.

    Time frame: Baseline, Week 12

  11. 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).

    Time frame: Visit 3 (Day 1 stopping rules)

  12. 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.

    Time frame: Baseline, 8 Hours Post Dose

  13. 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.

    Time frame: Baseline, 8 Hours Post Dose

  14. 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.

    Time frame: Baseline, Week 12

  15. 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.

    Time frame: Baseline, Week 12

  16. 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.

    Time frame: Baseline, Week 12

  17. 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.

    Time frame: Baseline, Week 12

  18. 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 1. Mild 2. Moderate 3. 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.

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

  19. 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.

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

06

Results

Posted Jul 23, 2021

Participant flow

Participant flow — Overall Study
MilestonePlacebo10 Milligram (mg) LY315420730 mg LY315420775 mg LY3154207
Started86868587
Received at least one dose of study drug86868587
Completed79786660
Not completed781927
Withdrew: Adverse event2266
Withdrew: Death0011
Withdrew: Lost to follow-up1200
Withdrew: Sponsor decision1018
Withdrew: Physician decision0024
Withdrew: Progressive disease0010
Withdrew: Protocol violation1023
Withdrew: Withdrawal due to assessment committee decision0002
Withdrew: Withdrawal by subject2452
Withdrew: Withdrawal due to caregiver circumstances0011

Outcome measures

PrimaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)1.04 (-0.339 to 2.373)0.15 (-1.206 to 1.496)0.96 (-0.448 to 2.362)0.26 (-1.310 to 1.801)
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Posterior mean difference: -0.89 · 95% CI -2.776 to 0.969Analyses were conducted using a bayesian mixed-model repeated measures (MMRM), and posterior mean change difference is reported.
  • Placebo vs 30 mg LY3154207 · Posterior mean difference: -0.08 · 95% CI -1.996 to 1.879Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.
  • Placebo vs 75 mg LY3154207 · Posterior mean difference: -0.78 · 95% CI -2.873 to 1.277Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.
SecondaryChange 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).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Score on a scale
Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score
Score on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score4.0 ± 0.133.8 ± 0.123.3 ± 0.133.1 ± 0.15
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.273 · Mean difference (net): -0.2 · 95% CI -0.54 to 0.15
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = <0.001 · Mean difference (net): -0.7 · 95% CI -1.02 to -0.30
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = < 0.001 · Mean difference (net): -0.9 · 95% CI -1.29 to -0.53
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Units on a scale
Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score64.14 ± 48.681-6.57 ± 48.396-42.88 ± 49.804-59.58 ± 54.379
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.303 · Mean difference (net): -70.71 · 95% CI -205.53 to 64.11
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.125 · Median difference (net): -107.02 · 95% CI -244.09 to 30.06
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.091 · Mean difference (net): -123.72 · 95% CI -267.18 to 19.74
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)-0.71 ± 0.707-1.11 ± 0.691-1.42 ± 0.720-1.59 ± 0.799
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.686 · Mean difference (net): -0.40 · 95% CI -2.34 to 1.54
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.485 · Mean difference (net): -0.71 · 95% CI -2.70 to 1.28
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.406 · Mean difference (net): -0.89 · 95% CI -2.98 to 1.21
SecondaryChange 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.

Time frame:
Screening (Baseline), Week 12
Reported as:
Least squares mean · Units on a scale
Change From Screening in the Montreal Cognitive Assessment (MoCA) Score
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Screening in the Montreal Cognitive Assessment (MoCA) Score0.90 ± 0.4321.34 ± 0.4231.12 ± 0.4481.84 ± 0.496
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.464 · Mean difference (net): 0.44 · 95% CI -0.74 to 1.63
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.720 · Mean difference (net): 0.22 · 95% CI -1.00 to 1.45
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.149 · Mean difference (net): 0.95 · 95% CI -0.34 to 2.24
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score and Individual Item Scores
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Total Score-1.62 ± 0.868-2.24 ± 0.852-3.32 ± 0.920-2.37 ± 1.005
Delusions0.13 ± 0.124-0.04 ± 0.121-0.25 ± 0.1300.02 ± 0.144
Hallucinations-0.09 ± 0.131-0.11 ± 0.128-0.44 ± 0.137-0.38 ± 0.151
Agitation/Aggression0.04 ± 0.130-0.06 ± 0.126-0.02 ± 0.135-0.20 ± 0.148
Depression/Dysphoria-0.22 ± 0.155-0.16 ± 0.151-0.33 ± 0.164-0.35 ± 0.179
Anxiety-0.15 ± 0.141-0.15 ± 0.1380.07 ± 0.149-0.22 ± 0.163
Elation/Euphoria0.14 ± 0.0690.03 ± 0.0680.00 ± 0.0740.06 ± 0.080
Apathy/Indifference-0.36 ± 0.191-0.81 ± 0.186-0.68 ± 0.202-0.55 ± 0.220
Disinhibition-0.13 ± 0.082-0.11 ± 0.0800.21 ± 0.087-0.09 ± 0.095
Irritability/Lability-0.19 ± 0.130-0.43 ± 0.127-0.25 ± 0.1370.02 ± 0.150
Aberrant Motor Behavior-0.13 ± 0.1060.03 ± 0.103-0.23 ± 0.112-0.09 ± 0.122
Sleep/Nighttime Behavior Disorders-0.19 ± 0.2870.00 ± 0.278-0.58 ± 0.302-0.30 ± 0.329
Appetite/Eating Disorders-0.37 ± 0.270-0.47 ± 0.263-0.80 ± 0.284-0.27 ± 0.311
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.607 · Mean difference (net): -0.62 · 95% CI -3.01 to 1.76
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.180 · Mean difference (net): -1.70 · 95% CI -4.19 to 0.79
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.572 · Mean difference (net): -0.75 · 95% CI -3.36 to 1.86
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.320 · Mean difference (net): -0.17 · 95% CI -0.51 to 0.17
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.037 · Mean difference (net): -0.38 · 95% CI -0.73 to -0.02
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.558 · Mean difference (net): -0.11 · 95% CI -0.49 to 0.26
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.924 · Mean difference (net): -0.02 · 95% CI -0.38 to 0.34
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.061 · Mean difference (net): -0.36 · 95% CI -0.73 to 0.02
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.148 · Mean difference (net): -0.29 · 95% CI -0.68 to 0.10
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.552 · Mean difference (net): -0.11 · 95% CI -0.46 to 0.25
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.735 · Mean difference (net): -0.06 · 95% CI -0.43 to 0.31
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.224 · Mean difference (net): -0.24 · 95% CI -0.63 to 0.15
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.783 · Mean difference (net): 0.06 · 95% CI -0.37 to 0.48
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.640 · Mean difference (net): -0.11 · 95% CI -0.55 to 0.34
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.592 · Mean difference (net): -0.13 · 95% CI -0.59 to 0.34
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.993 · Mean difference (net): 0.00 · 95% CI -0.39 to 0.39
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.290 · Mean difference (net): 0.22 · 95% CI -0.19 to 0.62
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.722 · Mean difference (net): -0.08 · 95% CI -0.50 to 0.35
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.246 · Mean difference (net): -0.11 · 95% CI -0.30 to 0.08
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.175 · Mean difference (net): -0.14 · 95% CI -0.34 to 0.06
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.482 · Mean difference (net): -0.07 · 95% CI -0.28 to 0.13
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.091 · Mean difference (net): -0.45 · 95% CI -0.97 to 0.07
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.248 · Mean difference (net): -0.32 · 95% CI -0.87 to 0.23
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.516 · Mean difference (net): -0.19 · 95% CI -0.76 to 0.38
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.875 · Mean difference (net): 0.02 · 95% CI -0.21 to 0.24
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.005 · Mean difference (net): 0.34 · 95% CI 0.10 to 0.57
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.761 · Mean difference (net): 0.04 · 95% CI -0.21 to 0.28
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.183 · Mean difference (net): -0.24 · 95% CI -0.60 to 0.12
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.765 · Mean difference (net): -0.06 · 95% CI -0.43 to 0.31
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.279 · Mean difference (net): 0.21 · 95% CI -0.18 to 0.61
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.252 · Mean difference (net): 0.17 · 95% CI -0.12 to 0.46
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.526 · Mean difference (net): -0.10 · 95% CI -0.40 to 0.20
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.800 · Mean difference (net): 0.04 · 95% CI -0.28 to 0.36
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.623 · Mean difference (net): 0.20 · 95% CI -0.59 to 0.98
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.354 · Mean difference (net): -0.39 · 95% CI -1.21 to 0.44
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.809 · Mean difference (net): -0.11 · 95% CI -0.97 to 0.75
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.790 · Mean difference (net): -0.10 · 95% CI -0.84 to 0.64
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.280 · Mean difference (net): -0.42 · 95% CI -1.20 to 0.35
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.797 · Mean difference (net): 0.11 · 95% CI -0.70 to 0.92
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Epworth Sleepiness Scale (ESS) Score
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline in the Epworth Sleepiness Scale (ESS) Score-0.33 ± 0.437-1.04 ± 0.426-1.21 ± 0.452-1.92 ± 0.500
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.247 · Mean difference (net): -0.71 · 95% CI -1.91 to 0.49
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.164 · Mean difference (net): -0.88 · 95% CI -2.12 to 0.36
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.017 · Mean difference (net): -1.59 · 95% CI -2.90 to -0.29
SecondaryChange 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).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I-III)
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I-III)-0.18 ± 2.112-6.58 ± 1.941-7.56 ± 2.084-10.77 ± 2.287
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.026 · Mean difference (net): -6.41 · 95% CI -12.04 to -0.77
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.014 · Mean difference (net): -7.39 · 95% CI -13.24 to -1.53
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = <0.001 · Mean difference (net): -10.60 · 95% CI -16.72 to -4.48
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score-0.32 ± 0.9760.23 ± 0.9612.09 ± 1.0181.24 ± 1.128
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.683 · Mean difference (net): 0.56 · 95% CI -2.13 to 3.24
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.089 · Mean difference (net): 2.41 · 95% CI -0.37 to 5.19
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.294 · Mean difference (net): 1.56 · 95% CI -1.37 to 4.49
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Units on a scale
Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score-0.19 ± 0.2800.44 ± 0.2710.88 ± 0.2920.30 ± 0.325
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.105 · Mean difference (net): 0.63 · 95% CI -0.13 to 1.40
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.009 · Mean difference (net): 1.07 · 95% CI 0.27 to 1.87
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.253 · Mean difference (net): 0.49 · 95% CI -0.35 to 1.33
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · Units on a scale
Change in MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Exam) From Baseline to Week 12
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Motor Experiences of Daily Living0.28 ± 0.656-1.45 ± 0.649-2.08 ± 0.700-3.22 ± 0.779
Motor Exam-0.12 ± 1.343-3.39 ± 1.240-3.40 ± 1.331-4.35 ± 1.434
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.061 · Mean difference (net): -1.74 · 95% CI -3.56 to 0.08
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.014 · Mean difference (net): -2.37 · 95% CI -4.26 to -0.47
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = <0.001 · Mean difference (net): -3.50 · 95% CI -5.50 to -1.51
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.074 · Mean difference (net): -3.27 · 95% CI -6.86 to 0.32
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.085 · Mean difference (net): -3.27 · 95% CI -7.00 to 0.45
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.032 · Mean difference (net): -4.23 · 95% CI -8.09 to -0.37
SecondaryNumber 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).

Time frame:
Visit 3 (Day 1 stopping rules)
Reported as:
Count of participants · Participants
Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 3
ParticipantsPlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 30011
SecondaryChange 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.

Time frame:
Baseline, 8 Hours Post Dose
Reported as:
Least squares mean · millimeter of mercury (mmHg)
Change From Baseline in Clinic Blood Pressure (BP) to 8 Hours Post Dose
millimeter of mercury (mmHg)Placebo10 mg LY315420730 mg LY315420775 mg LY3154207
Sitting Systolic Blood Pressure9.8 ± 1.9010.1 ± 1.8910.4 ± 1.9219.2 ± 1.87
Sitting Diastolic Blood Pressure4.6 ± 0.994.9 ± 0.985.5 ± 1.008.1 ± 0.97
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.898 · Mean difference (net): 0.3 · 95% CI -4.92 to 5.61
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.821 · Mean difference (net): 0.6 · 95% CI -4.71 to 5.94
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = <0.001 · Mean difference (net): 9.4 · 95% CI 4.11 to 14.61
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.805 · Mean difference (net): 0.3 · 95% CI -2.40 to 3.08
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.513 · Mean difference (net): 0.9 · 95% CI -1.85 to 3.69
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.011 · Mean difference (net): 3.6 · 95% CI 0.83 to 6.28
SecondaryChange 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.

Time frame:
Baseline, 8 Hours Post Dose
Reported as:
Least squares mean · beats/min
Change From Baseline in Pulse Rate to 8 Hours Post Dose
beats/minPlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline in Pulse Rate to 8 Hours Post Dose-2.2 ± 0.940.2 ± 0.951.3 ± 0.956.4 ± 0.93
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.065 · Mean difference (net): 2.5 · 95% CI -0.16 to 5.08
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.008 · Mean difference (net): 3.6 · 95% CI 0.93 to 6.21
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = <0.001 · Mean difference (net): 8.7 · 95% CI 6.06 to 11.27
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · millimeters of mercury (mmHg)
Change From Baseline In-clinic BP to Week 12
millimeters of mercury (mmHg)Placebo10 mg LY315420730 mg LY315420775 mg LY3154207
Sitting Systolic Blood Pressure-1.2 ± 1.220.5 ± 1.190.1 ± 1.293.0 ± 1.38
Sitting Diastolic Blood Pressure-0.9 ± 0.71-1.0 ± 0.70-0.2 ± 0.750.3 ± 0.80
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.339 · Mean difference (net): 1.6 · 95% CI -1.72 to 4.99
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.486 · Mean difference (net): 1.2 · 95% CI -2.26 to 4.73
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.024 · Mean difference (net): 4.2 · 95% CI 0.56 to 7.81
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.935 · Mean difference (net): -0.1 · 95% CI -2.04 to 1.88
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.505 · Mean difference (net): 0.7 · 95% CI -1.34 to 2.72
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.266 · Mean difference (net): 1.22 · 95% CI -0.91 to 3.30
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · beats/min
Change From Baseline in Pulse Rate to Week 12
beats/minPlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change From Baseline in Pulse Rate to Week 12-0.2 ± 0.670.3 ± 0.661.5 ± 0.712.6 ± 0.75
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.550 · Mean difference (net): 0.6 · 95% CI -1.28 to 2.41
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.069 · Mean difference (net): 1.8 · 95% CI -0.14 to 3.68
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.005 · Mean difference (net): 2.9 · 95% CI 0.89 to 4.83
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · mmHg
Change in Home Blood Pressure Measurement (HBPM), for SBP, DBP From Baseline to Week 12
mmHgPlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Sitting Systolic Blood Pressure-1.1 ± 2.52-8.2 ± 2.402.0 ± 2.58-2.2 ± 2.62
Sitting Diastolic Blood Pressure1.5 ± 1.50-2.8 ± 1.451.0 ± 1.55-0.8 ± 1.58
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.045 · Mean difference (net): -7.0 · 95% CI -13.92 to -0.15
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.390 · Mean difference (net): 3.1 · 95% CI -4.05 to 10.32
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.768 · Mean difference (net): -1.1 · 95% CI -8.32 to 6.16
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.041 · Mean difference (net): -4.3 · 95% CI -8.48 to -0.17
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.802 · Mean difference (net): -0.5 · 95% CI -4.81 to 3.72
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.284 · Mean difference (net): -2.4 · 95% CI -6.67 to 1.97
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · beats/min
Change in HBPM for Pulse Rate From Baseline to Week 12
beats/minPlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Change in HBPM for Pulse Rate From Baseline to Week 121.4 ± 1.521.4 ± 1.470.7 ± 1.590.8 ± 1.62
Statistical analysis
  • Placebo vs 10 mg LY3154207 · Mixed Models Analysis · p = 0.996 · Mean difference (net): 0.0 · 95% CI -4.17 to 4.19
  • Placebo vs 30 mg LY3154207 · Mixed Models Analysis · p = 0.767 · Mean difference (net): -0.7 · 95% CI -4.99 to 3.69
  • Placebo vs 75 mg LY3154207 · Mixed Models Analysis · p = 0.791 · Mean difference (net): -0.6 · 95% CI -4.96 to 3.79
SecondaryChange 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 1. Mild 2. Moderate 3. 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.

Time frame:
Week 12, Follow-up (2 Weeks after Week 12)
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Physician Withdrawal Checklist (PWC)-20 Total Score From Week 12 to In-Clinic Follow-up Visit
Units on a scalePlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
Week 12-1.51 ± 0.670-0.53 ± 0.690-0.47 ± 0.7010.05 ± 0.811
Follow-up-1.27 ± 0.8440.12 ± 0.8770.13 ± 0.9043.32 ± 1.040
Statistical analysis
  • Placebo vs 10 mg LY3154207 · ANCOVA · p = 0.312 · Mean difference (net): 0.98 · 95% CI -0.93 to 2.88
  • Placebo vs 30 mg LY3154207 · ANCOVA · p = 0.289 · Mean difference (net): 1.03 · 95% CI -0.89 to 2.95
  • Placebo vs 75 mg LY3154207 · ANCOVA · p = 0.141 · Mean difference (net): 1.56 · 95% CI -0.53 to 3.65
  • 10 mg LY3154207 vs 30 mg LY3154207 · ANCOVA · p = 0.954 · Mean difference (net): 0.06 · 95% CI -1.89 to 2.01
  • 10 mg LY3154207 vs 75 mg LY3154207 · ANCOVA · p = 0.584 · Mean difference (net): 0.59 · 95% CI -1.53 to 2.70
  • 30 mg LY3154207 vs 75 mg LY3154207 · ANCOVA · p = 0.623 · Mean difference (net): 0.53 · 95% CI -1.59 to 2.65
  • Placebo vs 10 mg LY3154207 · ANCOVA · p = 0.256 · Mean difference (net): 1.39 · 95% CI -1.02 to 3.79
  • Placebo vs 30 mg LY3154207 · ANCOVA · p = 0.258 · Mean difference (net): 1.41 · 95% CI -1.04 to 3.86
  • Placebo vs 75 mg LY3154207 · ANCOVA · p = <0.001 · Mean difference (net): 4.59 · 95% CI 1.93 to 7.25
  • 10 mg LY3154207 vs 30 mg LY3154207 · ANCOVA · p = 0.988 · Mean difference (net): 0.02 · 95% CI -2.47 to 2.51
  • 10 mg LY3154207 vs 75 mg LY3154207 · ANCOVA · p = 0.020 · Mean difference (net): 3.20 · 95% CI 0.51 to 5.90
  • 30 mg LY3154207 vs 75 mg LY3154207 · ANCOVA · p = 0.022 · Mean difference (net): 3.18 · 95% CI 0.46 to 5.91
SecondaryPharmacokinetics (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.

Time frame:
Day 1: 1-3 hours post-dose; Day 7, Day 14 and Day 42: post-dose; Day 84: pre-dose
Reported as:
Mean · nanogram per milliliter (ng/mL)
Pharmacokinetics (PK): Steady-State Trough Plasma Concentrations of LY3154207
nanogram per milliliter (ng/mL)10 mg LY315420730 mg LY315420775 mg LY3154207
Day 134.95 ± 28.8289.36 ± 88.03223.30 ± 208.63
Day 750.53 ± 38.20123.61 ± 100.89297.35 ± 242.47
Day 1445.85 ± 33.61129.24 ± 89.24321.65 ± 253.11
Day 4244.25 ± 33.93149.22 ± 122.01333.40 ± 257.74
Day 8425.01 ± 30.4359.39 ± 58.20126.53 ± 197.67

Adverse events

Collected over Up To 4 Months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/86 (0%)3/86 (3.5%)20/86 (23.3%)
10 mg LY31542070/86 (0%)5/86 (5.8%)26/86 (30.2%)
30 mg LY31542071/85 (1.2%)3/85 (3.5%)30/85 (35.3%)
75 mg LY31542071/87 (1.1%)10/87 (11.5%)43/87 (49.4%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventPlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
PancreatitisGastrointestinal disorders0/860/861/850/87
Septic shockInfections and infestations0/860/861/850/87
FallInjury, poisoning and procedural complications0/860/861/850/87
RhabdomyolysisMusculoskeletal and connective tissue disorders0/860/861/850/87
Angina pectorisCardiac disorders1/860/860/850/87
ConstipationGastrointestinal disorders0/861/860/850/87
OesophagitisGastrointestinal disorders1/860/860/850/87
Herpes zoster meningoencephalitisInfections and infestations0/861/860/850/87
Pseudomonas infectionInfections and infestations1/860/860/850/87
HyperammonaemiaMetabolism and nutrition disorders0/861/860/850/87
Most frequent other events
Showing 10 of 11
Most frequent other events
EventPlacebo10 mg LY315420730 mg LY315420775 mg LY3154207
FallInjury, poisoning and procedural complications4/8612/866/8512/87
FatigueGeneral disorders4/862/861/859/87
DizzinessNervous system disorders4/864/866/859/87
HallucinationPsychiatric disorders4/862/865/859/87
HeadacheNervous system disorders1/862/868/857/87
NauseaGastrointestinal disorders3/862/867/858/87
VomitingGastrointestinal disorders3/860/862/857/87
DiarrhoeaGastrointestinal disorders1/862/865/852/87
Urinary tract infectionInfections and infestations2/865/861/850/87
DyskinesiaNervous system disorders2/862/863/855/87

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)Placebo10 mg LY315420730 mg LY315420775 mg LY3154207Total
Mean73.00 ± 7.0272.50 ± 6.7071.90 ± 7.3573.00 ± 5.2172.60 ± 6.60
Sex: Female, Male
Sex: Female, Male(Participants)Placebo10 mg LY315420730 mg LY315420775 mg LY3154207Total
Female1613151559
Male70737072285
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo10 mg LY315420730 mg LY315420775 mg LY3154207Total
Hispanic or Latino8591133
Not Hispanic or Latino77817675309
Unknown or Not Reported10012
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo10 mg LY315420730 mg LY315420775 mg LY3154207Total
American Indian or Alaska Native11002
Asian21104
Native Hawaiian or Other Pacific Islander00000
Black or African American432211
White79818185326
More than one race00101
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)Placebo10 mg LY315420730 mg LY315420775 mg LY3154207Total
Canada323210
Puerto Rico524415
United States78827881319
07

Study locations

77 sites
  • 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, 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
    Saint 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
  • Santa Cruz Behavioral PSC
    Bayamón, 00961-6911, Puerto Rico
  • Cortex, PSC
    Las Piedras, 00771, Puerto Rico
  • Instituto de Neurologia Dra. Ivonne Fraga
    San Juan, 00918, Puerto Rico
  • University of Puerto Rico
    San Juan, 00936, Puerto Rico
08

References and documents

Publications

  • Wilbraham 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. PubMed 33029934 ↗

Study documents

  • Study protocol · Jan 25, 2019
  • Statistical analysis plan · Feb 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

09

Registry details

Key details

Study ID
NCT03305809
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 10, 2017
Start date
Nov 9, 2017
Primary completion
Jul 10, 2020
Completion
Jul 10, 2020
Results posted
Jul 23, 2021
Last update
Jul 23, 2021

Study contacts

Call 1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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