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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)

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ClinicalTrials.gov Identifier: NCT03305809
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 4, 2017
First Posted Date  ICMJE October 10, 2017
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE November 9, 2017
Estimated Primary Completion Date June 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
Change from Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) [ Time Frame: Baseline, Week 12 ]
Change from baseline in the CoA composite score of the CDR-CCB
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Change from Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the ADCS-CGIC score
  • Change from Baseline on the CDR-CCB Power of Attention (PoA) Composite Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the CDR-CCB PoA composite score
  • Change from Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog13) [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the 13-item ADAS-Cog13
  • Change from Screening in the Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Screening, Week 12 ]
    Change from Screening in the MoCA score
  • Change from Baseline in the Neuropsychiatric Inventory (NPI) Total Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the NPI total score
  • Change from Baseline in the Epworth Sleepiness Scale (ESS) Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the ESS score
  • Change from Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the MDS-UPDRS total score
  • Change from Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the PDAQ-15 total score
  • Change from Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in D-KEFS verbal fluency test score
  • Change from Baseline in Systolic Blood Pressure (SBP) to Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from baseline in SBP to week 12
  • Change from Baseline in SBP to 8 Hours Post Dose [ Time Frame: Baseline, 8 Hours Post Dose ]
    Change from baseline in SBP to 8 hours post dose
  • Change from Baseline in Pulse Rate to Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from baseline in pulse rate to week 12
  • Change from Baseline in Pulse Rate to 8 Hours Post Dose [ Time Frame: Baseline, 8 Hours Post Dose ]
    Change from baseline in pulse rate to 8 hours post dose
  • Change from Week 12 in the Physician Withdrawal Checklist (PWC)-20 Total Score [ Time Frame: Week 12, Follow-up (2 Days after Week 12 Visit) ]
    Change from week 12 in PWC-20 to Follow-up
  • Pharmacokinetics (PK): Steady-State Trough Plasma Concentrations of LY3154207 [ Time Frame: Week 12 ]
    PK: Steady-State Trough Plasma Concentrations of LY3154207
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • Change from Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the ADCS-CGIC score
  • Change from Baseline on the CDR-CCB Power of Attention (PoA) Composite Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the CDR-CCB PoA composite score
  • Change from Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog13) [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the 13-item ADAS-Cog13
  • Change from Screening in the Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Screening, Week 12 ]
    Change from Screening in the MoCA score
  • Change from Baseline in the Neuropsychiatric Inventory (NPI) Total Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the NPI total score
  • Change from Baseline in the Epworth Sleepiness Scale (ESS) Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the ESS score
  • Change from Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the MDS-UPDRS total score
  • Change from Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in the PDAQ-15 total score
  • Change from Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in D-KEFS verbal fluency test score
  • Change from Baseline in Systolic Blood Pressure (SBP) to Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from baseline in SBP to week 12
  • Change from Baseline in SBP to 8 Hours Post Dose [ Time Frame: Baseline, 8 Hours Post Dose ]
    Change from baseline in SBP to 8 hours post dose
  • Change from Baseline in Pulse Rate to Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from baseline in pulse rate to week 12
  • Change from Baseline in Pulse Rate to 8 Hours Post Dose [ Time Frame: Baseline, 8 Hours Post Dose ]
    Change from baseline in pulse rate to 8 hours post dose
  • Pharmacokinetics (PK): Steady-State Trough Plasma Concentrations of LY3154207 [ Time Frame: Week 12 ]
    PK: Steady-State Trough Plasma Concentrations of LY3154207
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lewy Body Dementia
Intervention  ICMJE
  • Drug: LY3154207
    Administered orally.
  • Drug: Placebo
    Administered orally.
Study Arms  ICMJE
  • Experimental: LY3154207 High Dose
    LY3154207 administered orally.
    Intervention: Drug: LY3154207
  • Experimental: LY3154207 Mid Dose
    LY3154207 administered orally.
    Intervention: Drug: LY3154207
  • Experimental: LY3154207 Low Dose
    LY3154207 administered orally.
    Intervention: Drug: LY3154207
  • Placebo Comparator: Placebo
    Placebo administered orally.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2017)
340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 22, 2020
Estimated Primary Completion Date June 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment.
  • Meet diagnostic criteria for PD per MDS criteria or DLB per 4th Consensus Report of the DLB Consortium.
  • Have a score on the MoCA of 10 - 23.
  • Are Modified Hoehn and Yahr Stages 0 - 4.
  • Have a blood pressure (BP) or pulse rate at screening and randomization, as determined by three sequential BP/pulse rate measurements in a seated position:

    • Participants <60 years old:

      1. A mean systolic BP less than or equal to 140 millimeters of mercury (mmHg), a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal 90 beats/minute in a seated position.
      2. Each of the 3 systolic BP measurement must be less than 180 mmHg
    • Participants ≥60 years old:

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

Exclusion Criteria:

  • Are women of childbearing potential.
  • Have significant central nervous system or psychiatric disease, other than PD or DLB, that in the investigator's opinion may affect cognition or the ability to complete the study.
  • Have a history in the last 6 months of transient ischemic attacks or ischemic stroke.
  • Have a history of intra cerebral hemorrhage due to hypertension.
  • Have a history of hypertensive encephalopathy.
  • Have atypical or secondary parkinsonism due to drugs (e.g., antipsychotics) or disease (such as progressive supranuclear palsy, essential tremor, multiple system atrophy (e.g. striatonigral degeneration, olivopontocerebellar atrophy), or postencephalitic parkinsonism).
  • Have a current implantable intracranial stimulator or history of intracranial ablation surgery (e.g., subthalamic, globus pallidus-internal segment [GPi]).
  • Have a history of substance abuse within the past 1 year (drug categories defined by the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition [DSM-5], and/or substance dependence within the past 1 year, not including caffeine and nicotine.
  • Have a serious or unstable medical illness, other than idiopathic LBD (PDD or DLB), including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality as determined by the investigator.

    • Have a history in the last 6 months of exertional angina, unstable angina, myocardial infarction, and acute coronary syndrome.
    • Have a history of heart failure of either New York Heart Association Class III or IV.
    • A history of additional risk factors for Torsades de Pointes (TdP; [e.g., chronic hypokalemia, family history of Long QT Syndrome]).
  • Participants with acute liver disease (e.g. acute viral hepatitis, alcoholic hepatitis); participants with a known chronic liver disease (e.g. hepatitis B, C, alcoholic liver disease, cirrhosis); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or higher than 2X upper limit of normal (ULN); total bilirubin (TBL) equal to or higher than 1.5X ULN; (except for participants with Gilbert's syndrome); or alkaline phosphatase (ALP) equal to or higher than 2X ULN.
  • Participants have answered 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the Columbia Suicide Severity Rating Scale (C-SSRS)- Children's version, or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt).
  • Have used antipsychotic medications, with the exception of clozapine, quetiapine, pimavanserin in the 6 months prior to screening and at any time during the course of the study.
  • Have used anticholinergics trihexyphenidyl and benztropine in the 4 weeks prior to screening and at any time during the course of the study.
  • Have motor conditions for which the antiparkinsonian treatment is expected to change during the course of the study, as well as unpredictable motor fluctuations that in the investigator's opinion would interfere with administering assessments.
  • Are taking any medications or food, herbal or dietary supplements that are inhibitors (e.g., ketoconazole, grapefruit juice), or strong/moderate inducers of cytochrome P450 3A4 (CYP3A4) (e.g., rifampicin) or are unable or unwilling to discontinue usage of them 4 weeks prior to first dose of study drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT03305809
Other Study ID Numbers  ICMJE 16261
I7S-MC-HBEH ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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
PRS Account Eli Lilly and Company
Verification Date February 1, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP