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LY3154207 for Parkinson's Disease Dementia (PRESENCE)

Start: November 9, 2017
End: July 10, 2020
Enrollment: 340

What Is This Study About?

This trial will test multiple doses of the investigational drug LY3154207 in people with mild-to-moderate Parkinson's disease dementia.

Do I Qualify To Participate in This Study?

Minimum Age: 40 Years

Maximum Age: 85 Years

Must have:

  • Idiopathic Parkinsons's disease with at least 2 years of symptoms
  • Dementia as defined by a decline in cognitive function that has resulted in functional impairment
  • Montreal Cognitive Assessment score of 10 to 23
  • Modified Hoehn and Yahr Stages 1 to 4
  • Blood pressure or pulse rate at screening and randomization, as determined by three sequential measurements in a seated position:
    • Participants less than 60 years old: 140 mmHg or less mean systolic, 90 mmHg or less mean diastolic, and 90 or fewer beats/minute mean pulse rate
    • Participants 60 or older: 150 mmHg or less mean systolic, 90 mmHg or less mean diastolic, and 90 or fewer beats/minute mean pulse rate
    • All participants: Each of the three systolic measurements must be less than 180 mmHg
  • Use of anti-parkinsonian agents must be stable for at least 4 weeks
  • Use of medications affecting cognition (rivastigmine, galantamine, donepezil, memantine) or antidepressant medications must be stable for at least 8 weeks
  • Use of clozapine, quetiapine, and pimavanserin to address drug-induced or disease-related psychosis must be stable for 4 weeks
  • Use of anti-hypertensive medications must be stable for at least 3 months
  • Men should use appropriate contraception
  • Caregiver with at least 10 hours of contact per week who can attend visits

Must NOT have:

  • Women of childbearing potential
  • Significant central nervous system disease, other than Parkinson's, that may affect cognition or the ability to complete the study, including Alzheimer's disease and other dementias
  • Transient ischemic attacks or ischemic stroke in past 6 months
  • History of intracerebral hemorrhage due to hypertension
  • History of hypertensive encephalopathy
  • Atypical or secondary parkinsonism due to drugs (e.g., antipsychotics) or disease, such as progressive supranuclear palsy, essential tremor, multiple system atrophy, or postencephalitic parkinsonism
  • Current implantable intracranial stimulator or history of intracranial ablation surgery
  • Current or any previous diagnosis of bipolar disorder, schizophrenia, or other primary psychotic disorder
  • Poorly controlled psychosis (hallucinations or delusions) or any other psychiatric disorder that would interfere with the study or study results
  • Substance abuse dependence within the past year, not including caffeine and nicotine
  • Geriatric Depression Scale score greater than 6
  • Serious or unstable medical illness, other than idiopathic Parkinson's disease, including heart, liver, lung, blood, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or electrocardiogram abnormality
  • Exertional angina, unstable angina, heart attack, or acute coronary syndrome in past 6 months 
  • History of heart failure of either New York Heart Association Class III or IV
  • History of additional risk factors for torsades de pointes
  • Acute liver disease (e.g., acute viral hepatitis or alcoholic hepatitis); chronic liver disease (e.g., hepatitis B, C, alcoholic liver disease, or cirrhosis); alanine aminotransferase or aspartate aminotransferase equal to or higher than 2 times the upper limit of normal (ULN); total bilirubin equal to or higher than 1.5 times ULN (except for participants with Gilbert's syndrome); or alkaline phosphatase equal to or higher than 2 times ULN
  • Suicidal ideation or any suicide-related behaviors
  • Use of antipsychotic medications, with the exception of clozapine, quetiapine, and pimavanserin, in past 6 months
  • Use of trihexyphenidyl and benztropine in past 4 weeks
  • Motor conditions for which the antiparkinsonian treatment is expected to change during the course of the study, as well as unpredictable motor fluctuations that could interfere with study
  • Taking any medications or food, herbal, or dietary supplements that are inhibitors (e.g., ketoconazole or grapefruit juice) or strong/moderate inducers of CYP3A4 (e.g., rifampicin)
 

Who Is the General Study Contact?

For more information about this study or study sites, please contact Eli Lilly and Company at 877-285-4559 (toll-free), 317-615-4559, or clinicaltrials.gov@lilly.com

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Alabama
University of Alabama Birmingham
Birmingham, AL 35233
Arizona
Barrow Neurological Institute
Phoenix, AZ 85013
Mayo Clinic of Scottsdale
Scottsdale, AZ 85259
Banner Sun Health Research Institute
Sun City, AZ 85351
University of Arizona Health Sciences
Tucson, AZ 85724
California
Parkinson'S & Movement Disorder Institute
Fountain Valley, CA 92708
University of CA, Irvine
Irvine, CA 92697
Collaborative Neuroscience Network - CNS
Long Beach, CA 90806
University of Southern California School of Medicine
Los Angeles, CA 90033
Pacific Neuroscience Medical Group
Oxnard, CA 93030
Stanford Neuroscience Health Center
Palo Alto, CA 94304
SC3 Research Group Inc Pasadena
Pasadena, CA 91105
SC3 Research Group Inc Reseda
Reseda, CA 91335
University of California, Davis - Health Systems
Sacramento, CA 95817
Colorado
University of Colorado Hospital
Aurora, CO 80045
Denver Neurological Research
Denver, CO 80210
Rocky Mountain Movement Disorders Center
Englewood, CO 80113
Connecticut
New England Institute for Clinical Research
Stamford, CT 06905
Hartford Healthcare Chase Movement Disorders Center
Vernon, CT 06066
Delaware
Christiana Care Health Service
Newark, DE 19713
District of Columbia
Georgetown University Hospital
Washington, DC 20007
Florida
JEM Research Institute
Atlantis, FL 33462
Visionary Investigators Network
Aventura, FL 33180
Parkinson's Disease and Movement Disorders
Boca Raton, FL 33486
Norman Fixel Institute for Neurological Diseases (FIND)
Gainesville, FL 32608
ClinCloud, LLC
Maitland, FL 32751
Visionary Investigators Network
Miami, FL 33133
Suncoast Research Group, LLC
Miami, FL 33135
VIN - Victor Faradji
Miami, FL 33176
Collier Neurologic Specialists
Naples, FL 34105
Renstar Medical Research
Ocala, FL 34470
Compass Research
Orlando, FL 32806
Neurology Associates of Ormond Beach
Ormond Beach, FL 32174
Visionary Investigators Network -VIN-Margarita Almeida
Pembroke Pines, FL 33026
Axiom Research
Tampa, FL 33609
Georgia
Emory University
Atlanta, GA 30329
Atlanta Center of Medical Research
Atlanta, GA 30331
Illinois
Central DuPage Hospital
Winfield, IL 60190
Indiana
Indiana University School of Medicine
Indianapolis, IN 46202
Josephson Wallack Munshower Neurology
Indianapolis, IN 46256
Kansas
University of Kansas School of Medicine
Kansas City, KS 66160
Maine
Maine Neurology
Scarborough, ME 04074
Massachusetts
New England Neurological Associates, PC
Methuen, MA 01844
Michigan
University of Michigan
Ann Arbor, MI 48109
QUEST Research Institute
Farmington Hills, MI 48334
Missouri
Clinical Research Professionals
Chesterfield, MO 63005
Washington University School of Medicine
Saint Louis, MO 63110
Nevada
Cleveland Clinic of Las Vegas
Las Vegas, NV 89106
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, NH 03756-0001
New Jersey
The Cognitive and Research Center of NJ
Springfield, NJ 07081
Bio Behavioral Health
Toms River, NJ 08755
New York
Dent Neurological Institute
Amherst, NY 14226
Alzheimer's Disease and Memory Disorders Center
Buffalo, NY 14203
Adirondack Medical Research
Glens Falls, NY 12801
Parker Jewish Insititue for Heatlh Care and Rehabilition
New Hyde Park, NY 11040
NYU Langone
New York, NY 10016
North Carolina
Carolinas Healthcare System
Charlotte, NC 28207
Wake Forest University Health Sciences
Winston-Salem, NC 27157
Pennsylvania
Penn State Univ. Milton S. Hershey Medical Center
Hershey, PA 17033
Pennsylvania Hospital
Philadelphia, PA 19107
Thomas Jefferson University
Philadelphia, PA 19107
Abington Neurological Associates
Willow Grove, PA 19090
South Carolina
Medical University of South Carolina
Charleston, SC 29425
Texas
Texas Neurology, PA
Dallas, TX 75214
Neurology Consultants of Dallas, PA
Dallas, TX 75243
Baylor College of Medicine
Houston, TX 77030
Houston Methodist Research Ins
Houston, TX 77030
Virginia
Sentara Neurology Specialists
Virginia Beach, VA 23456
Washington
Northwest Clinical Research Center
Bellevue, WA 98007-4209
Evergreen Professional Plaza
Kirkland, WA 98034
Wisconsin
University of Wisconsin-Madison Hospital and Health Clinic
Madison, WI 53705

Who Sponsors This Study?

Lead: Eli Lilly and Company

Source: ClinicalTrials.gov ID: NCT03305809