Summary

for people ages 40-85 (full criteria)
at Irvine, California and other locations
study started
estimated completion

Description

Summary

A randomized placebo-controlled trial in individuals with Parkinson's disease dementia to evaluate the safety and efficacy of three doses of study drug LY3154207 in participants with mild-to-moderate Parkinson's disease dementia treated for 12 weeks.

Official Title

Effect of LY3154207 on Cognition in Mild-to-Moderate Parkinson's Disease Dementia (PDD)

Keywords

Parkinson's Disease DementiaParkinson disease dementiaParkinson diseaseDopamineCognitionDementiaLY3154207LY3154207 Mid Dose

Eligibility

You can join if…

Open to people ages 40-85

  • Have Idiopathic Parkinsons's Disease (PD) per MDS criteria with at least 2 years of PD symptoms.
  • Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment.
  • Have a score on the MoCA of 10 - 23.
  • Are Modified Hoehn and Yahr Stages 1 - 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:
  • 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 4 weeks prior to baseline.
  • If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 8 weeks prior to baseline.
  • If on antidepressant medications, participants must be on stable dosage for at least 8 weeks prior to baseline.
  • If on Clozapine, quetiapine and pimavanserin to address drug-induced or disease-related psychosis, participants must be on stable dosage for 4 weeks prior to baseline.
  • If on anti-hypertensive medications, participants must be on stable dosage for at least 3 months 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.

You CAN'T join if...

  • Are women of childbearing potential.
  • Have significant central nervous system disease, other than PD, that may affect cognition or the ability to complete the study, including but not limited to, other dementias (e.g., Alzheimer's disease).
  • 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 current or any previous diagnosis of bipolar disorder, schizophrenia, or other primary psychotic disorder.
  • Have poorly controlled psychosis (hallucinations or delusions) that in the opinion of the investigator would interfere with the subject's ability to be compliant with the study protocol.
  • Have any other psychiatric disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol.
  • 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 Geriatric Depression Scale - Short Form (GDS-S) score of >6 at screening.
  • Have a serious or unstable medical illness, other than idiopathic PD, 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.
  • Have used trihexyphenidyl and benztropine in the 4 weeks prior to screening.
  • 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 currently taking any medications or food, herbal or dietary supplements that are inhibitors (e.g., ketoconazole, grapefruit juice) or strong/moderate inducers of CYP3A4 (e.g. rifampicin).

Locations

  • University of California, Irvineaccepting new patients
    IrvineCalifornia92697United States
  • Parkinson'S & Movement Disorder Instituteaccepting new patients
    Fountain ValleyCalifornia92708United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LY3154207 in Participants With Parkinson's Disease Dementia (PRESENCE)
ID
NCT03305809
Phase
Phase 2
Study Type
Interventional
Last Updated