AzTrials
AzTrials

Lewy Body DementiaPhase 2PRESENCENCT03305809

A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)

A Phase 2 study testing LY3154207 in people with Lewy Body Dementia, run by Eli Lilly and Company at 77 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A randomized placebo-controlled trial to evaluate the safety and efficacy of three doses of study drug LY3154207 treated for 12 weeks in participants with mild-to-moderate dementia associated with LBD (PDD or DLB). Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Lewy Body Dementia
What is being tested?
LY3154207
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
344 participants
Where
77 sitesin 3 countries
Study dates
9 Nov 2017to 10 Jul 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 18Show fewer
  • A mean systolic BP less than or equal to 140 millimeters of mercury (mmHg), a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal 90 beats/minute in a seated position.
  • Each of the 3 systolic BP measurement must be less than 180 mmHg
  • Participants ≥60 years old:
  • A mean systolic BP less than or equal to 150 mmHg, a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal to 90 beats/min in a seated position.
  • Each of the 3 systolic BP measurement must be less than 180 mmHg
  • If on anti-parkinsonian agents, participants must be on stable dosage for at least 3 weeks prior to screening, and should remain on stable doses during the course of the study.
  • If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
  • If on antidepressant medications, participants must be on stable dosage for at least 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
  • If on clozapine, quetiapine, and pimavanserin to address drug induced or disease related psychosis, participants must be on stable dosage for 3 weeks prior to screening and should remain at a stable dosage during the course of the study.
  • If on antihypertensive medications, participants must be on stable dosage for at least 3 weeks prior to screening.
  • Men should use appropriate contraception.
  • All participants must have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant to screening, baseline, day 7, day 42, day 84 and follow-up.

Who cannot join

  • 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).
Show all 18Show fewer
  • Have a current implantable intracranial stimulator or history of intracranial ablation surgery (e.g., subthalamic, globus pallidus-internal segment [GPi]).
  • Have a history of substance abuse within the past 1 year (drug categories defined by the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition [DSM-5], and/or substance dependence within the past 1 year, not including caffeine and nicotine.
  • Have a serious or unstable medical illness, other than idiopathic LBD (PDD or DLB), including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality as determined by the investigator.
  • Have a history in the last 6 months of exertional angina, unstable angina, myocardial infarction, and acute coronary syndrome.
  • Have a history of heart failure of either New York Heart Association Class III or IV.
  • A history of additional risk factors for Torsades de Pointes (TdP; [e.g., chronic hypokalemia, family history of Long QT Syndrome]).
  • Participants with acute liver disease (e.g. acute viral hepatitis, alcoholic hepatitis); participants with a known chronic liver disease (e.g. hepatitis B, C, alcoholic liver disease, cirrhosis); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or higher than 2X upper limit of normal (ULN); total bilirubin (TBL) equal to or higher than 1.5X ULN; (except for participants with Gilbert's syndrome); or alkaline phosphatase (ALP) equal to or higher than 2X ULN.
  • Participants have answered 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the Columbia Suicide Severity Rating Scale (C-SSRS)- Children's version, or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt).
  • Have used antipsychotic medications, with the exception of clozapine, quetiapine, pimavanserin in the 6 months prior to screening and at any time during the course of the study.
  • Have used anticholinergics trihexyphenidyl and benztropine in the 4 weeks prior to screening and at any time during the course of the study.
  • Have motor conditions for which the antiparkinsonian treatment is expected to change during the course of the study, as well as unpredictable motor fluctuations that in the investigator's opinion would interfere with administering assessments.
  • Are taking any medications or food, herbal or dietary supplements that are inhibitors (e.g., ketoconazole, grapefruit juice), or strong/moderate inducers of cytochrome P450 3A4 (CYP3A4) (e.g., rifampicin) or are unable or unwilling to discontinue usage of them 4 weeks prior to first dose of study drug.

Trial locations and contacts

77 sites in 3 countries.

77 sites in 3 countries

United States71 sites

  • Dent Neurological Institute

    Amherst, New York, 14226

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30329

  • Atlanta Center of Medical Research

    Atlanta, Georgia, 30331

  • JEM Research Institute

    Atlantis, Florida, 33462

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Visionary Investigators Network

    Aventura, Florida, 33180

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007-4209

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233

  • Parkinson's Disease and Movement Disorders

    Boca Raton, Florida, 33486

  • Alzheimer's Disease and Memory Disorders Center

    Buffalo, New York, 14203

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Healthcare System

    Charlotte, North Carolina, 28207

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Texas Neurology, PA

    Dallas, Texas, 75214

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75243

  • Denver Neurological Research

    Denver, Colorado, 80210

  • Rocky Mountain Movement Disorders Center

    Englewood, Colorado, 80113

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

  • Parkinson'S & Movement Disorder Institute

    Fountain Valley, California, 92708

  • Norman Fixel Institute for Neurological Diseases (FIND)

    Gainesville, Florida, 32608

  • Adirondack Medical Research

    Glens Falls, New York, 12801

  • Penn State Univ. Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Research Ins

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Josephson Wallack Munshower Neurology

    Indianapolis, Indiana, 46256

  • University of CA, Irvine

    Irvine, California, 92697

  • University of Kansas School of Medicine

    Kansas City, Kansas, 66160

  • Evergreen Professional Plaza

    Kirkland, Washington, 98034

  • Cleveland Clinic of Las Vegas

    Las Vegas, Nevada, 89106

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0001

  • Collaborative Neuroscience Network - CNS

    Long Beach, California, 90806

  • University of Southern California School of Medicine

    Los Angeles, California, 90033

  • University of Wisconsin-Madison Hospital and Health Clinic

    Madison, Wisconsin, 53705

  • ClinCloud, LLC

    Maitland, Florida, 32751

  • New England Neurological Associates, PC

    Methuen, Massachusetts, 01844

  • Visionary Investigators Network

    Miami, Florida, 33133

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • VIN - Victor Faradji

    Miami, Florida, 33176

  • Collier Neurologic Specialists

    Naples, Florida, 34105

  • Parker Jewish Insititue for Heatlh Care and Rehabilition

    New Hyde Park, New York, 11040

  • NYU Langone

    New York, New York, 10016

  • Christiana Care Health Service

    Newark, Delaware, 19713

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Compass Research

    Orlando, Florida, 32806

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • Stanford Neuroscience Health Center

    Palo Alto, California, 94304

  • SC3 Research Group Inc Pasadena

    Pasadena, California, 91105

  • Visionary Investigators Network -VIN-Margarita Almeida

    Pembroke Pines, Florida, 33026

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • SC3 Research Group Inc Reseda

    Reseda, California, 91335

  • University of California, Davis - Health Systems

    Sacramento, California, 95817

  • Maine Neurology

    Scarborough, Maine, 04074

  • Mayo Clinic of Scottsdale

    Scottsdale, Arizona, 85259

  • The Cognitive and Research Center of NJ

    Springfield, New Jersey, 07081

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Axiom Research

    Tampa, Florida, 33609

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • University of Arizona Health Sciences

    Tucson, Arizona, 85724

  • Hartford Healthcare Chase Movement Disorders Center

    Vernon, Connecticut, 06066

  • Sentara Neurology Specialists

    Virginia Beach, Virginia, 23456

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Puerto Rico4 sites

  • Santa Cruz Behavioral PSC

    Bayamón, 00961-6911

  • Cortex, PSC

    Las Piedras, PR, 00771

  • Instituto de Neurologia Dra. Ivonne Fraga

    San Juan, PR, 00918

  • University of Puerto Rico

    San Juan, PR, 00936

Other trials in Puerto Rico

Canada2 sites

  • Ottawa Hospital Research Institute

    Ottawa, K1Y 4E9

  • Toronto Memory Program

    Toronto, Ontario, M3B 2S7

Other trials in Canada

About this study

Official title: Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)

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).

Being tested
LY3154207, Placebo
Keywords
Parkinson Disease Dementia, Parkinson Disease, Dopamine, Cognition, Lewy Body Dementia, Dementia with Lewy Bodies
Medical subject headings
Lewy Body Disease, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3154207Drug

    Administered orally.

  • PlaceboDrug

    Administered orally.

Study groups in NCT03305809
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo administered orally once a day (QD).
Receives: Drug: Placebo
10 milligram (mg) LY3154207ExperimentalParticipants received 10 mg LY3154207 administered orally QD.
Receives: Drug: LY3154207
30 mg LY3154207ExperimentalParticipants received 30 mg LY3154207 administered orally QD.
Receives: Drug: LY3154207
75 mg LY3154207ExperimentalParticipants received 75 mg LY3154207 administered orally QD.
Receives: Drug: LY3154207

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval.

    Measured: Baseline, Week 12

Secondary outcomes (19)

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

    The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating. A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). 1= Very much better 2= Much better 3= A little better 4= Same 5= A little worse 6= Much worse 7= Very much worse. Least squares (LS) means were calculated using mixed model repeated measures adjusting for treatment + visit + treatment*visit + age*acheifl + age + concomitant use of acetylcholinesterase inhibitor (AChEI).

    Measured: Baseline, Week 12

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

    The PoA is a composite score derived from the CDR-CCB that measures the intensity of concentration (ability to focus attention): the faster the responses, the more processes are being brought to bear upon the task. Power of attention is calculated from the sum of three cognitive function speed tests: simple reaction time, choice reaction time and the speed of detections in digit vigilance task. Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment Values are calculated by a computer and higher scores mean better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.

    Measured: Baseline, Week 12

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

    The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.

    Measured: Baseline, Week 12

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

    The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale. The MoCA is divided into 7 subscores (maximum possible subscore): visuospatial/executive (5 points), naming (3 points), memory (5 points for delayed recall), attention (6 points), language (3 points), abstraction (2 points) and orientation to time and place (6 points). A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.

    Measured: Screening (Baseline), Week 12

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

    The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD),as well as other related dementing disorders.It assesses 12 behavioral disturbances,namely delusions,hallucinations,depression/dysphoria,anxiety,agitation/aggression,elation/euphoria,disinhibition,irritability/lability,apathy, aberrant motor activity, night-time behavior disturbances,and appetite/eating abnormalities.The frequency scored from 0 (never) to 4 (very frequently).The Severity scored from 0 (none) to 3 (marked).The domain score is obtained by multiplying frequency and severity scores.The total NPI score is sum total of all of individual domain scores (0-144).Higher score indiciates more abnormal behaviors.LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.

    Measured: Baseline, Week 12

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

    The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.

    Measured: Baseline, Week 12

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

    Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for MDS-UPDRS MDS-UPDRS Part I (non-motor experiences of daily living) and Part II (motor experiences of daily living) scores, total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + levodopa equivalency dose (LED).

    Measured: Baseline, Week 12

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

    The PDAQ-15 is a 15-item measure of instrumental activities of daily living (IADL) that are impacted by cognitive impairment in participants with parkinson's disease dementia (PDD). The PDAQ-15 is derived from the original 50-item scale, which has demonstrated test-retest reliability, construct validity, sensitivity, and specificity to Parkinson's disease (PD) cognitive impairment and the questionnaire is completed by the caregiver. The score range is 0 to 60, with higher scores indicating better function. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.

    Measured: Baseline, Week 12

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

    The DKEFS verbal fluency category switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. Scales scores vary from 0 min to N/A max (no concrete maximum). Higher score = higher ability in language processing. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.

    Measured: Baseline, Week 12

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

    Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for Part II total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + LED dose.

    Measured: Baseline, Week 12

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

    Number of participants who met the potentially clinically significant vital signs criteria at 3 consecutive time points at visit 3 were reported. In the event of an unacceptable rate of participants meeting day 1 stopping rules at other doses, adjustments to doses may be made for subsequently randomized participants at the discretion of the internal assessment committee (IAC).

    Measured: Visit 3 (Day 1 stopping rules)

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

    Systolic and diastolic blood pressure obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.

    Measured: Baseline, 8 Hours Post Dose

  13. Change From Baseline in Pulse Rate to 8 Hours Post Dose

    Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.

    Measured: Baseline, 8 Hours Post Dose

  14. Change From Baseline In-clinic BP to Week 12

    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.

    Measured: Baseline, Week 12

  15. Change From Baseline in Pulse Rate to Week 12

    Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.

    Measured: Baseline, Week 12

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

    Systolic and diastolic blood pressure obtained from ABPM was evaluated. Participants followed a standardized measurement protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.

    Measured: Baseline, Week 12

  17. Change in HBPM for Pulse Rate From Baseline to Week 12

    Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to week 12 and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.

    Measured: Baseline, Week 12

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

    The Penn PWC-20 is a 20-item checklist originally developed to assess the severity of withdrawal symptoms in anxiolytic medication discontinuation. To determine a change in the Intensity of Discontinuation symptoms, the PWC-20 administered by a trained clinician/rater to assess the intensity of discontinuation symptoms. The assessment has 20 items evaluated to detect withdrawal symptoms. Symptoms are rated on a scale of 0-3.

    1. Not present
    2. Mild
    3. Moderate
    4. 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.

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

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

    Trough measurements of LY3154207 concentration in plasma at Day 1, Day 7, Day 14, Day 42 and Day 84 was evaluated.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2017
  2. Study start9 Nov 2017
  3. Primary completion10 Jul 2020
  4. Study completion10 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03305809
Sponsor's protocol ID
16261
Other IDs
I7S-MC-HBEH
Acronym
PRESENCE
Status last verified
Jul 2021
First submitted
4 Oct 2017
Last updated
23 Jul 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 36905719

  • Wilbraham D, Biglan KM, Svensson KA, Tsai M, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator (D1PAM), in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Apr;10(4):393-403. doi: 10.1002/cpdd.874. Epub 2020 Oct 7.

    PubMed 33029934

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3154207 in people with Lewy Body Dementia, run by Eli Lilly and Company at 77 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Puerto Rico, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03305809, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in