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| ID | Type | Description | Link |
|---|---|---|---|
| I7S-MC-HBEH | Other Identifier | Eli Lilly and Company |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo administered orally once a day (QD). |
|
| 10 milligram (mg) LY3154207 | Experimental | Participants received 10 mg LY3154207 administered orally QD. |
|
| 30 mg LY3154207 | Experimental | Participants received 30 mg LY3154207 administered orally QD. |
|
| 75 mg LY3154207 | Experimental | Participants received 75 mg LY3154207 administered orally QD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3154207 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) | The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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:
Participants ≥60 years old:
If on anti-parkinsonian agents, participants must be on stable dosage for at least 3 weeks prior to screening, and should remain on stable doses during the course of the study.
If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
If on antidepressant medications, participants must be on stable dosage for at least 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
If on clozapine, quetiapine, and pimavanserin to address drug induced or disease related psychosis, participants must be on stable dosage for 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
If on antihypertensive medications, participants must be on stable dosage for at least 3 weeks prior to screening.
Men should use appropriate contraception.
All participants must have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant to screening, baseline, day 7, day 42, day 84 and follow-up.
Exclusion Criteria:
Are women of childbearing potential.
Have significant central nervous system or psychiatric disease, other than PD or DLB, that in the investigator's opinion may affect cognition or the ability to complete the study.
Have a history in the last 6 months of transient ischemic attacks or ischemic stroke.
Have a history of intra cerebral hemorrhage due to hypertension.
Have a history of hypertensive encephalopathy.
Have atypical or secondary parkinsonism due to drugs (e.g., antipsychotics) or disease (such as progressive supranuclear palsy, essential tremor, multiple system atrophy (e.g. striatonigral degeneration, olivopontocerebellar atrophy), or postencephalitic parkinsonism).
Have a current implantable intracranial stimulator or history of intracranial ablation surgery (e.g., subthalamic, globus pallidus-internal segment [GPi]).
Have a history of substance abuse within the past 1 year (drug categories defined by the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition [DSM-5], and/or substance dependence within the past 1 year, not including caffeine and nicotine.
Have a serious or unstable medical illness, other than idiopathic LBD (PDD or DLB), including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality as determined by the investigator.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Barrow Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36905719 | Derived | Chen C, Kowahl NR, Rainaldi E, Burq M, Munsie LM, Battioui C, Wang J, Biglan K, Marks WJ Jr, Kapur R. Wrist-worn sensor-based measurements for drug effect detection with small samples in people with Lewy Body Dementia. Parkinsonism Relat Disord. 2023 Apr;109:105355. doi: 10.1016/j.parkreldis.2023.105355. Epub 2023 Mar 4. | |
| 33029934 |
| Label | URL |
|---|---|
| A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB) (PRESENCE) | View source |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo administered orally once a day (QD). |
| FG001 | 10 Milligram (mg) LY3154207 | Participants received 10 mg LY3154207 administered orally QD. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2019 | Jun 24, 2021 |
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| Placebo | Drug | Administered orally. |
|
| 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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
| 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. | Day 1: 1-3 hours post-dose; Day 7, Day 14 and Day 42: post-dose; Day 84: pre-dose |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Mayo Clinic of Scottsdale | Scottsdale | Arizona | 85259 | United States |
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States |
| University of Arizona Health Sciences | Tucson | Arizona | 85724 | United States |
| Parkinson'S & Movement Disorder Institute | Fountain Valley | California | 92708 | United States |
| University of CA, Irvine | Irvine | California | 92697 | United States |
| Collaborative Neuroscience Network - CNS | Long Beach | California | 90806 | United States |
| University of Southern California School of Medicine | Los Angeles | California | 90033 | United States |
| Pacific Neuroscience Medical Group | Oxnard | California | 93030 | United States |
| Stanford Neuroscience Health Center | Palo Alto | California | 94304 | United States |
| SC3 Research Group Inc Pasadena | Pasadena | California | 91105 | United States |
| SC3 Research Group Inc Reseda | Reseda | California | 91335 | United States |
| University of California, Davis - Health Systems | Sacramento | California | 95817 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Denver Neurological Research | Denver | Colorado | 80210 | United States |
| Rocky Mountain Movement Disorders Center | Englewood | Colorado | 80113 | United States |
| New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| Hartford Healthcare Chase Movement Disorders Center | Vernon | Connecticut | 06066 | United States |
| Christiana Care Health Service | Newark | Delaware | 19713 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| Visionary Investigators Network | Aventura | Florida | 33180 | United States |
| Parkinson's Disease and Movement Disorders | Boca Raton | Florida | 33486 | United States |
| Norman Fixel Institute for Neurological Diseases (FIND) | Gainesville | Florida | 32608 | United States |
| ClinCloud, LLC | Maitland | Florida | 32751 | United States |
| Visionary Investigators Network | Miami | Florida | 33133 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| VIN - Victor Faradji | Miami | Florida | 33176 | United States |
| Collier Neurologic Specialists | Naples | Florida | 34105 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | United States |
| Visionary Investigators Network -VIN-Margarita Almeida | Pembroke Pines | Florida | 33026 | United States |
| Axiom Research | Tampa | Florida | 33609 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Atlanta Center of Medical Research | Atlanta | Georgia | 30331 | United States |
| Central DuPage Hospital | Winfield | Illinois | 60190 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Josephson Wallack Munshower Neurology | Indianapolis | Indiana | 46256 | United States |
| University of Kansas School of Medicine | Kansas City | Kansas | 66160 | United States |
| Maine Neurology | Scarborough | Maine | 04074 | United States |
| New England Neurological Associates, PC | Methuen | Massachusetts | 01844 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| QUEST Research Institute | Farmington Hills | Michigan | 48334 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Cleveland Clinic of Las Vegas | Las Vegas | Nevada | 89106 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0001 | United States |
| The Cognitive and Research Center of NJ | Springfield | New Jersey | 07081 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| Dent Neurological Institute | Amherst | New York | 14226 | United States |
| Alzheimer's Disease and Memory Disorders Center | Buffalo | New York | 14203 | United States |
| Adirondack Medical Research | Glens Falls | New York | 12801 | United States |
| Parker Jewish Insititue for Heatlh Care and Rehabilition | New Hyde Park | New York | 11040 | United States |
| NYU Langone | New York | New York | 10016 | United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28207 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Penn State Univ. Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Neurology, PA | Dallas | Texas | 75214 | United States |
| Neurology Consultants of Dallas, PA | Dallas | Texas | 75243 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Houston Methodist Research Ins | Houston | Texas | 77030 | United States |
| Sentara Neurology Specialists | Virginia Beach | Virginia | 23456 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007-4209 | United States |
| Evergreen Professional Plaza | Kirkland | Washington | 98034 | United States |
| University of Wisconsin-Madison Hospital and Health Clinic | Madison | Wisconsin | 53705 | United States |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| Ottawa Hospital Research Institute | Ottawa | K1Y 4E9 | Canada |
| Cortex, PSC | Las Piedras | PR | 00771 | Puerto Rico |
| Instituto de Neurologia Dra. Ivonne Fraga | San Juan | PR | 00918 | Puerto Rico |
| University of Puerto Rico | San Juan | PR | 00936 | Puerto Rico |
| Santa Cruz Behavioral PSC | Bayamón | 00961-6911 | Puerto Rico |
| 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. |
| FG002 | 30 mg LY3154207 | Participants received 30 mg LY3154207 administered orally QD. |
| FG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo administered orally QD. |
| BG001 | 10 mg LY3154207 | Participants received 10 mg LY3154207 administered orally QD. |
| BG002 | 30 mg LY3154207 | Participants received 30 mg LY3154207 administered orally QD. |
| BG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) | The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval. | All randomized participants who received at least 1 dose of study drug, who had the baseline efficacy assessment and had at least 1 postdose efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score | The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating. A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). 1= Very much better 2= Much better 3= A little better 4= Same 5= A little worse 6= Much worse 7= Very much worse. Least squares (LS) means were calculated using mixed model repeated measures adjusting for treatment + visit + treatment*visit + age*acheifl + age + concomitant use of acetylcholinesterase inhibitor (AChEI). | All randomized participants who received at least one dose of study drug with baseline and post-baseline CGIC data. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score | The PoA is a composite score derived from the CDR-CCB that measures the intensity of concentration (ability to focus attention): the faster the responses, the more processes are being brought to bear upon the task. Power of attention is calculated from the sum of three cognitive function speed tests: simple reaction time, choice reaction time and the speed of detections in digit vigilance task. Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment Values are calculated by a computer and higher scores mean better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI. | All randomized participants who received at least one dose of study drug with baseline and post-baseline CDR-CCB PoA data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) | The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI. | All randomized participants who received at least one dose of study drug with baseline and post-baseline ADAS-Cog13 data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Screening in the Montreal Cognitive Assessment (MoCA) Score | The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale. The MoCA is divided into 7 subscores (maximum possible subscore): visuospatial/executive (5 points), naming (3 points), memory (5 points for delayed recall), attention (6 points), language (3 points), abstraction (2 points) and orientation to time and place (6 points). A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI. | All randomized participants who received at least one dose of study drug with baseline and post-baseline MoCA data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Screening (Baseline), Week 12 |
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| Secondary | Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score and Individual Item Scores | The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD),as well as other related dementing disorders.It assesses 12 behavioral disturbances,namely delusions,hallucinations,depression/dysphoria,anxiety,agitation/aggression,elation/euphoria,disinhibition,irritability/lability,apathy, aberrant motor activity, night-time behavior disturbances,and appetite/eating abnormalities.The frequency scored from 0 (never) to 4 (very frequently).The Severity scored from 0 (none) to 3 (marked).The domain score is obtained by multiplying frequency and severity scores.The total NPI score is sum total of all of individual domain scores (0-144).Higher score indiciates more abnormal behaviors.LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI. | All randomized participants who received at least one dose of study drug with baseline and post-baseline NPI score data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in the Epworth Sleepiness Scale (ESS) Score | The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI. | All randomized participants who received at least one dose of study drug with baseline and post-baseline ESS data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I-III) | Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for MDS-UPDRS MDS-UPDRS Part I (non-motor experiences of daily living) and Part II (motor experiences of daily living) scores, total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + levodopa equivalency dose (LED). | All randomized participants who received at least one dose of study drug with baseline and post-baseline MDS-UPDRS data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score | The PDAQ-15 is a 15-item measure of instrumental activities of daily living (IADL) that are impacted by cognitive impairment in participants with parkinson's disease dementia (PDD). The PDAQ-15 is derived from the original 50-item scale, which has demonstrated test-retest reliability, construct validity, sensitivity, and specificity to Parkinson's disease (PD) cognitive impairment and the questionnaire is completed by the caregiver. The score range is 0 to 60, with higher scores indicating better function. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI. | All randomized participants who received at least one dose of study drug with baseline and post-baseline PDAQ-15 data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score | The DKEFS verbal fluency category switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. Scales scores vary from 0 min to N/A max (no concrete maximum). Higher score = higher ability in language processing. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI. | All randomized participants who received at least one dose of study drug with baseline and post-baseline D-KEFS data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Exam) From Baseline to Week 12 | Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for Part II total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + LED dose. | All randomized participants who received at least one dose of study drug with baseline and post-baseline MDS-UPDRS data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 3 | Number of participants who met the potentially clinically significant vital signs criteria at 3 consecutive time points at visit 3 were reported. In the event of an unacceptable rate of participants meeting day 1 stopping rules at other doses, adjustments to doses may be made for subsequently randomized participants at the discretion of the internal assessment committee (IAC). | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Visit 3 (Day 1 stopping rules) |
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| Secondary | Change From Baseline in Clinic Blood Pressure (BP) to 8 Hours Post Dose | Systolic and diastolic blood pressure obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit. | All randomized participants who received at least one dose of study drug with baseline and post-baseline BP data. | Posted | Least Squares Mean | Standard Error | millimeter of mercury (mmHg) | Baseline, 8 Hours Post Dose |
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| Secondary | Change From Baseline in Pulse Rate to 8 Hours Post Dose | Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit. | All randomized participants who received at least one dose of study drug with baseline and post-baseline pulse rate data. | Posted | Least Squares Mean | Standard Error | beats/min | Baseline, 8 Hours Post Dose |
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| Secondary | Change From Baseline In-clinic BP to Week 12 | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit. | All randomized participants who received at least one dose of study drug with baseline and post-baseline BP data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, Week 12 |
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| Secondary | Change From Baseline in Pulse Rate to Week 12 | Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit. | All randomized participants who received at least one dose of study drug with baseline and post-baseline pulse rate data. | Posted | Least Squares Mean | Standard Error | beats/min | Baseline, Week 12 |
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| Secondary | Change in Home Blood Pressure Measurement (HBPM), for SBP, DBP From Baseline to Week 12 | Systolic and diastolic blood pressure obtained from ABPM was evaluated. Participants followed a standardized measurement protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit. | All randomized participants who received at least one dose of study drug with baseline and post-baseline BP data. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, Week 12 |
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| Secondary | Change in HBPM for Pulse Rate From Baseline to Week 12 | Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to week 12 and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit. | All randomized participants who received at least one dose of study drug with baseline and post-baseline pulse rate data. | Posted | Least Squares Mean | Standard Error | beats/min | Baseline, Week 12 |
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| Secondary | Change From Baseline in the Physician Withdrawal Checklist (PWC)-20 Total Score From Week 12 to In-Clinic Follow-up Visit | The Penn PWC-20 is a 20-item checklist originally developed to assess the severity of withdrawal symptoms in anxiolytic medication discontinuation. To determine a change in the Intensity of Discontinuation symptoms, the PWC-20 administered by a trained clinician/rater to assess the intensity of discontinuation symptoms. The assessment has 20 items evaluated to detect withdrawal symptoms. Symptoms are rated on a scale of 0-3. 0. Not present
| All randomized participants who received at least one dose of study drug with baseline and post-baseline PWC-20 data. | Posted | Least Squares Mean | Standard Error | Units on a scale | Week 12, Follow-up (2 Weeks after Week 12) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Steady-State Trough Plasma Concentrations of LY3154207 | Trough measurements of LY3154207 concentration in plasma at Day 1, Day 7, Day 14, Day 42 and Day 84 was evaluated. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1: 1-3 hours post-dose; Day 7, Day 14 and Day 42: post-dose; Day 84: pre-dose |
|
|
Up To 4 Months
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo administered orally QD. | 0 | 86 | 3 | 86 | 20 | 86 |
| EG001 | 10 mg LY3154207 | Participants received 10 mg LY3154207 administered orally QD. | 0 | 86 | 5 | 86 | 26 | 86 |
| EG002 | 30 mg LY3154207 | Participants received 30 mg LY3154207 administered orally QD. | 1 | 85 | 3 | 85 | 30 | 85 |
| EG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. | 1 | 87 | 10 | 87 | 43 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster meningoencephalitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hemianaesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertensive encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2021 | Jun 24, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707472 | LY3154207 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Puerto Rico |
|
| United States |
|
| Posterior Mean Difference |
| -0.08 |
| 2-Sided |
| 95 |
| -1.996 |
| 1.879 |
Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported. |
| Superiority |
| Posterior Mean Difference | -0.78 | 2-Sided | 95 | -2.873 | 1.277 | Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported. | Superiority |
| OG002 |
| 30 mg LY3154207 |
Participants received 30 mg LY3154207 administered orally QD. |
| OG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
| OG002 |
| 30 mg LY3154207 |
Participants received 30 mg LY3154207 administered orally QD. |
| OG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
Participants received 30 mg LY3154207 administered orally QD.
| OG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
Participants received 30 mg LY3154207 administered orally QD.
| OG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
| OG002 | 30 mg LY3154207 | Participants received 30 mg LY3154207 administered orally QD. |
| OG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
| OG002 | 30 mg LY3154207 | Participants received 30 mg LY3154207 administered orally QD. |
| OG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
Participants received 30 mg LY3154207 administered orally QD.
| OG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
| OG003 |
| 75 mg LY3154207 |
Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
| 30 mg LY3154207 |
Participants received 30 mg LY3154207 administered orally QD. |
| OG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
|
|
|
Participants received 75 mg LY3154207 administered orally QD.
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Participants received 75 mg LY3154207 administered orally QD.
|
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|
| 30 mg LY3154207 |
Participants received 30 mg LY3154207 administered orally QD. |
| OG003 | 75 mg LY3154207 | Participants received 75 mg LY3154207 administered orally QD. |
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