A Study of LY3154207 in Participants With Parkinson's Disease Dementia



Status:Recruiting
Conditions:Parkinsons Disease, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - 85
Updated:4/5/2019
Start Date:November 9, 2017
End Date:December 6, 2019
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:Clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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

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.


Inclusion Criteria:

- 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:

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 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.

Exclusion Criteria:

- 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).
We found this trial at
71
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Phoenix, Arizona 85013
Principal Investigator: Ryan Walsh
Phone: 602-406-8284
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Marian Evatt
Phone: 404-778-7777
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Amy Amara
Phone: 205-934-2402
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Gainesville, Florida 32611
(352) 392-3261
Principal Investigator: Adolfo Ramirez-Zamora
Phone: 352-294-5400
University of Florida Gainesville UF has a long history of established programs in international education,...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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Phone: 713-798-7438
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Iowa City, Iowa 52242
Principal Investigator: Nadakumar Narayanan
Phone: 319-356-4757
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2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: Bruno Gallo
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
Principal Investigator: Anette V. Nieves
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Principal Investigator: Ira J Goodman
Phone: 407-210-1320
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
Principal Investigator: James Scott
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Amherst, New York 14226
Principal Investigator: Horace Capote
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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Phone: 734-936-7910
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811 Juniper St NE
Atlanta, Georgia 30308
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Phone: 4048815800
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Atlantis, Florida 33462
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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Phone: 303-724-8225
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Bellevue, Washington 98007
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Boca Raton, Florida 33486
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Buffalo, New York 14203
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28203
Principal Investigator: Sanjay Iyer
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Chesterfield, Missouri 63141
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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Phone: 480-256-6444
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Dallas, Texas 75231
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Dallas, Texas 75214
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Principal Investigator: Adam J Wolff
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Farmington Hills, Michigan 48334
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Fountain Valley, California 92708
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92 Broad Street
Glens Falls, New York 12801
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
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Phone: 317-963-7415
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Indianapolis, Indiana 46256
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Phone: 317-537-6060
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Irvine, California 92697
949-824-5011
Principal Investigator: Neal Hermanowicz
Phone: 714-456-7720
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Kansas City, Kansas 66160
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Kirkland, Washington 98034
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Las Vegas, Nevada 89102
Principal Investigator: Zoltran Mari
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Stephen Lee
Phone: 603-650-4646
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Long Beach, California 90806
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Los Angeles, California 90033
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Madison, Wisconsin 53705
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Maitland, Florida 32751
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354 Merrimack Street
Methuen, Massachusetts 01844
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8940 North Kendall Drive
Miami, Florida 33176
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Naples, Florida 34102
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New York, New York 10016
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4701 Ogletown-Stanton Road
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
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Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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Reseda, California 91335
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Sacramento, California 95817
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Scarborough, Maine 04074
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
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Stamford, Connecticut 06905
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Sun City, Arizona 85351
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Toms River, New Jersey 08755
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1 Valleybrook Drive
Toronto, Ontario M3B 2S7
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1295 North Martin Avenue
Tucson, Arizona 85724
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Vernon, Connecticut 06066
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Virginia Beach, Virginia 23456
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Fernando Pagan
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Winfield, Illinois 60190
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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