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
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Among 110 studies in Lewy Body Disease with a site in United States — 32 open to participants now, 40 under way, 1 of them phase 3. Lewy Body Disease · United States.
Among the 110 studies in Lewy Body Disease with a site in United States, this one is the 17th largest by enrollment of the 78 interventional ones that give a count, is one of 5 that started in 2017, is one of 21 in phase 2, and was the 31st registered.
239 studies on the registry are indexed under Lewy Body Disease; 88 are open to participants now.
Browse Lewy Body Disease studies →32 of the 110 studies in Lewy Body Disease with a site in United States are open now. Recruiting first, the newest first:
University of Washington · Sites in United States
Ages 18+
NYU Langone Health · Sites in United States
Ages 18–90 · Healthy volunteers
Eli Lilly and Company · Sites in United States, Japan, Korea, Republic of and 1 more country
Ages 55–85
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Sites in United States
Ages 18+
University of Pennsylvania · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 63 Lewy Body Disease studies recruiting now, 41 (65%) set no upper age limit and none (0%) stop at 75 or younger; 10 take children under 18; 31 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
110 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 24 · Phase 3 4 · Phase 4 8
First in 2002; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 344 is above the median of 89 across 152 interventional studies indexed under Lewy Body Disease.
Median enrollment 86 across the 78 interventional studies, 225 across the 31 observational. Of the 66 that completed or were terminated, 33 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 110 have an industry lead sponsor. The 10 most frequent:
Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
Eli Lilly and Company has 3 studies filed under Lewy Body Disease — fewer than ten, so there is no comparison to draw.
13 of the studies in Lewy Body Disease with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06098612Massachusetts General HospitalPET Imaging Evaluation of [11C]SY08 | 2026-11 |
| NCT01799915NYU Langone HealthNatural History Study of Synucleinopathies | 2026-12-30 |
| NCT03233646Duke UniversityRetinal Imaging in Neurodegenerative Disease | 2026-12-31 |
| NCT03702907Georgetown UniversityDC Longitudinal Study on Aging and Specimen Bank | 2027-01 |
| NCT04246437Daniel Claassen[18F]F-DOPA Imaging in Patients With Autonomic Failure | 2027-02-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 110 studies in Lewy Body Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Participants ≥60 years old:
Exclusion Criteria:
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 laboratory or (ECG) abnormality as determined by the investigator.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received placebo administered orally once a day (QD).
Drug: Placebo
Participants received 10 mg LY3154207 administered orally QD.
Drug: LY3154207
Participants received 30 mg LY3154207 administered orally QD.
Drug: LY3154207
Participants received 75 mg LY3154207 administered orally QD.
Drug: LY3154207
Administered orally.
Administered orally.
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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)
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
| Milestone | Placebo | 10 Milligram (mg) LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Started | 86 | 86 | 85 | 87 |
| Received at least one dose of study drug | 86 | 86 | 85 | 87 |
| Completed | 79 | 78 | 66 | 60 |
| Not completed | 7 | 8 | 19 | 27 |
| Withdrew: Adverse event | 2 | 2 | 6 | 6 |
| Withdrew: Death | 0 | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 2 | 0 | 0 |
| Withdrew: Sponsor decision | 1 | 0 | 1 | 8 |
| Withdrew: Physician decision | 0 | 0 | 2 | 4 |
| Withdrew: Progressive disease | 0 | 0 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 2 | 3 |
| Withdrew: Withdrawal due to assessment committee decision | 0 | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 2 | 4 | 5 | 2 |
| Withdrew: Withdrawal due to caregiver circumstances | 0 | 0 | 1 | 1 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 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) |
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).
| Score on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score | 4.0 ± 0.13 | 3.8 ± 0.12 | 3.3 ± 0.13 | 3.1 ± 0.15 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score | 64.14 ± 48.681 | -6.57 ± 48.396 | -42.88 ± 49.804 | -59.58 ± 54.379 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 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 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Change From Screening in the Montreal Cognitive Assessment (MoCA) Score | 0.90 ± 0.432 | 1.34 ± 0.423 | 1.12 ± 0.448 | 1.84 ± 0.496 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Total Score | -1.62 ± 0.868 | -2.24 ± 0.852 | -3.32 ± 0.920 | -2.37 ± 1.005 |
| Delusions | 0.13 ± 0.124 | -0.04 ± 0.121 | -0.25 ± 0.130 | 0.02 ± 0.144 |
| Hallucinations | -0.09 ± 0.131 | -0.11 ± 0.128 | -0.44 ± 0.137 | -0.38 ± 0.151 |
| Agitation/Aggression | 0.04 ± 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 ± 0.138 | 0.07 ± 0.149 | -0.22 ± 0.163 |
| Elation/Euphoria | 0.14 ± 0.069 | 0.03 ± 0.068 | 0.00 ± 0.074 | 0.06 ± 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 ± 0.080 | 0.21 ± 0.087 | -0.09 ± 0.095 |
| Irritability/Lability | -0.19 ± 0.130 | -0.43 ± 0.127 | -0.25 ± 0.137 | 0.02 ± 0.150 |
| Aberrant Motor Behavior | -0.13 ± 0.106 | 0.03 ± 0.103 | -0.23 ± 0.112 | -0.09 ± 0.122 |
| Sleep/Nighttime Behavior Disorders | -0.19 ± 0.287 | 0.00 ± 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 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 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 |
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).
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 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 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score | -0.32 ± 0.976 | 0.23 ± 0.961 | 2.09 ± 1.018 | 1.24 ± 1.128 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score | -0.19 ± 0.280 | 0.44 ± 0.271 | 0.88 ± 0.292 | 0.30 ± 0.325 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Motor Experiences of Daily Living | 0.28 ± 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 |
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).
| Participants | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 3 | 0 | 0 | 1 | 1 |
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.
| millimeter of mercury (mmHg) | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Sitting Systolic Blood Pressure | 9.8 ± 1.90 | 10.1 ± 1.89 | 10.4 ± 1.92 | 19.2 ± 1.87 |
| Sitting Diastolic Blood Pressure | 4.6 ± 0.99 | 4.9 ± 0.98 | 5.5 ± 1.00 | 8.1 ± 0.97 |
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.
| beats/min | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Change From Baseline in Pulse Rate to 8 Hours Post Dose | -2.2 ± 0.94 | 0.2 ± 0.95 | 1.3 ± 0.95 | 6.4 ± 0.93 |
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.
| millimeters of mercury (mmHg) | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Sitting Systolic Blood Pressure | -1.2 ± 1.22 | 0.5 ± 1.19 | 0.1 ± 1.29 | 3.0 ± 1.38 |
| Sitting Diastolic Blood Pressure | -0.9 ± 0.71 | -1.0 ± 0.70 | -0.2 ± 0.75 | 0.3 ± 0.80 |
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.
| beats/min | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Change From Baseline in Pulse Rate to Week 12 | -0.2 ± 0.67 | 0.3 ± 0.66 | 1.5 ± 0.71 | 2.6 ± 0.75 |
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.
| mmHg | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Sitting Systolic Blood Pressure | -1.1 ± 2.52 | -8.2 ± 2.40 | 2.0 ± 2.58 | -2.2 ± 2.62 |
| Sitting Diastolic Blood Pressure | 1.5 ± 1.50 | -2.8 ± 1.45 | 1.0 ± 1.55 | -0.8 ± 1.58 |
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.
| beats/min | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Change in HBPM for Pulse Rate From Baseline to Week 12 | 1.4 ± 1.52 | 1.4 ± 1.47 | 0.7 ± 1.59 | 0.8 ± 1.62 |
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.
| Units on a scale | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| Week 12 | -1.51 ± 0.670 | -0.53 ± 0.690 | -0.47 ± 0.701 | 0.05 ± 0.811 |
| Follow-up | -1.27 ± 0.844 | 0.12 ± 0.877 | 0.13 ± 0.904 | 3.32 ± 1.040 |
Trough measurements of LY3154207 concentration in plasma at Day 1, Day 7, Day 14, Day 42 and Day 84 was evaluated.
| nanogram per milliliter (ng/mL) | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|
| Day 1 | 34.95 ± 28.82 | 89.36 ± 88.03 | 223.30 ± 208.63 |
| Day 7 | 50.53 ± 38.20 | 123.61 ± 100.89 | 297.35 ± 242.47 |
| Day 14 | 45.85 ± 33.61 | 129.24 ± 89.24 | 321.65 ± 253.11 |
| Day 42 | 44.25 ± 33.93 | 149.22 ± 122.01 | 333.40 ± 257.74 |
| Day 84 | 25.01 ± 30.43 | 59.39 ± 58.20 | 126.53 ± 197.67 |
Collected over Up To 4 Months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/86 (0%) | 3/86 (3.5%) | 20/86 (23.3%) |
| 10 mg LY3154207 | 0/86 (0%) | 5/86 (5.8%) | 26/86 (30.2%) |
| 30 mg LY3154207 | 1/85 (1.2%) | 3/85 (3.5%) | 30/85 (35.3%) |
| 75 mg LY3154207 | 1/87 (1.1%) | 10/87 (11.5%) | 43/87 (49.4%) |
| Event | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| PancreatitisGastrointestinal disorders | 0/86 | 0/86 | 1/85 | 0/87 |
| Septic shockInfections and infestations | 0/86 | 0/86 | 1/85 | 0/87 |
| FallInjury, poisoning and procedural complications | 0/86 | 0/86 | 1/85 | 0/87 |
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 0/86 | 0/86 | 1/85 | 0/87 |
| Angina pectorisCardiac disorders | 1/86 | 0/86 | 0/85 | 0/87 |
| ConstipationGastrointestinal disorders | 0/86 | 1/86 | 0/85 | 0/87 |
| OesophagitisGastrointestinal disorders | 1/86 | 0/86 | 0/85 | 0/87 |
| Herpes zoster meningoencephalitisInfections and infestations | 0/86 | 1/86 | 0/85 | 0/87 |
| Pseudomonas infectionInfections and infestations | 1/86 | 0/86 | 0/85 | 0/87 |
| HyperammonaemiaMetabolism and nutrition disorders | 0/86 | 1/86 | 0/85 | 0/87 |
| Event | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 |
|---|---|---|---|---|
| FallInjury, poisoning and procedural complications | 4/86 | 12/86 | 6/85 | 12/87 |
| FatigueGeneral disorders | 4/86 | 2/86 | 1/85 | 9/87 |
| DizzinessNervous system disorders | 4/86 | 4/86 | 6/85 | 9/87 |
| HallucinationPsychiatric disorders | 4/86 | 2/86 | 5/85 | 9/87 |
| HeadacheNervous system disorders | 1/86 | 2/86 | 8/85 | 7/87 |
| NauseaGastrointestinal disorders | 3/86 | 2/86 | 7/85 | 8/87 |
| VomitingGastrointestinal disorders | 3/86 | 0/86 | 2/85 | 7/87 |
| DiarrhoeaGastrointestinal disorders | 1/86 | 2/86 | 5/85 | 2/87 |
| Urinary tract infectionInfections and infestations | 2/86 | 5/86 | 1/85 | 0/87 |
| DyskinesiaNervous system disorders | 2/86 | 2/86 | 3/85 | 5/87 |
All randomized participants.
| Age, Continuous(years) | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 | Total |
|---|---|---|---|---|---|
| Mean | 73.00 ± 7.02 | 72.50 ± 6.70 | 71.90 ± 7.35 | 73.00 ± 5.21 | 72.60 ± 6.60 |
| Sex: Female, Male(Participants) | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 | Total |
|---|---|---|---|---|---|
| Female | 16 | 13 | 15 | 15 | 59 |
| Male | 70 | 73 | 70 | 72 | 285 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 8 | 5 | 9 | 11 | 33 |
| Not Hispanic or Latino | 77 | 81 | 76 | 75 | 309 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 0 | 2 |
| Asian | 2 | 1 | 1 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 2 | 2 | 11 |
| White | 79 | 81 | 81 | 85 | 326 |
| More than one race | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | 10 mg LY3154207 | 30 mg LY3154207 | 75 mg LY3154207 | Total |
|---|---|---|---|---|---|
| Canada | 3 | 2 | 3 | 2 | 10 |
| Puerto Rico | 5 | 2 | 4 | 4 | 15 |
| United States | 78 | 82 | 78 | 81 | 319 |
PDFs hosted by the registry, ClinicalTrials.gov.
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, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Nov 2017 to primary completion in Jul 2020, 32 months.
Results were first posted in Jul 2021, 1 year after primary completion.
Of 24 phase 2 interventional studies under Lewy Body Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 32 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: LY3154207