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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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
Principal Investigator: James Scott
Phone: 386-676-6340
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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
Principal Investigator: Joohi Jimenez-Shahed
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
Phone: 305-631-6704
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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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Amherst, New York 14226
Principal Investigator: Horace Capote
Phone: 716-250-2000
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Kara Wyant
Phone: 734-936-7910
University of Michigan The University of Michigan was founded in 1817 as one of the...
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Principal Investigator: Robert Alan Riesenberg
Phone: 4048815800
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Atlantis, Florida 33462
Principal Investigator: Mark A Goldstein
Phone: 561-968-2933
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Samantha Holden
Phone: 303-724-8225
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Bellevue, Washington 98007
Principal Investigator: Arifulla Khan
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Boca Raton, Florida 33486
Principal Investigator: Stuart H Isaacson
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Buffalo, New York 14203
Principal Investigator: Kinga Gyorgyi Szigeti
Phone: 7168884722
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Federico Rodriguez-Porcel
Phone: 843-792-7262
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28203
Principal Investigator: Sanjay Iyer
Phone: 704-446-1900
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Chesterfield, Missouri 63141
Principal Investigator: Siddharth Kaul
Phone: 636-220-1200
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Jennifer Goldman
Phone: 480-256-6444
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Dallas, Texas 75231
Principal Investigator: Nirav Pavasia
Phone: 214-750-9977
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Dallas, Texas 75214
Principal Investigator: Waleed El Feky
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Denver, Colorado 80210
Principal Investigator: Adam J Wolff
Phone: 303-715-9024
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Englewood, Colorado 80113
Principal Investigator: Rajeev Kumar
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Farmington Hills, Michigan 48334
Principal Investigator: Aaron L Ellenbogen
Phone: 248-957-8940
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Fountain Valley, California 92708
Principal Investigator: DANIEL D TRUONG
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92 Broad Street
Glens Falls, New York 12801
Principal Investigator: Andrew W Garner
Phone: 518-798-9401
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Hershey, Pennsylvania 17033
Principal Investigator: Thyagarajan Subramanian
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Houston, Texas 77030
Principal Investigator: WILLIAM ONDO
Phone: 713-790-3311
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Jared Brosch
Phone: 317-963-7415
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Indianapolis, Indiana 46256
Principal Investigator: Kristi George
Phone: 317-537-6060
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Irvine, California 92697
949-824-5011
Principal Investigator: Neal Hermanowicz
Phone: 714-456-7720
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Kansas City, Kansas 66160
Principal Investigator: Rajesh B Pahwa
Phone: 913-588-7159
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Kirkland, Washington 98034
Principal Investigator: Pinky Agarwal
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Las Vegas, Nevada 89102
Principal Investigator: Zoltran Mari
Phone: 702-483-6049
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Stephen Lee
Phone: 603-650-4646
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Long Beach, California 90806
Principal Investigator: Omid Omidvar
Phone: 562-304-1742
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Los Angeles, California 90033
Principal Investigator: Daniel Togasaki
Phone: 323-442-5791
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Madison, Wisconsin 53705
Principal Investigator: Kathleen Shannon
Phone: 608-262-7003
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Maitland, Florida 32751
Principal Investigator: Alicia Cabrera
Phone: 407-636-4031
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354 Merrimack Street
Methuen, Massachusetts 01844
Principal Investigator: Marc Shay
Phone: 978-687-2321
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8940 North Kendall Drive
Miami, Florida 33176
Principal Investigator: Victor Faradji
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Naples, Florida 34102
Principal Investigator: John D. Campbell
Phone: 239-262-8971
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New York, New York 10016
Principal Investigator: Andrew Feigin
Phone: 718-834-0070
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
Principal Investigator: Justin Martello
Phone: 302-623-3017
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Oxnard, California
Principal Investigator: James Sutton
Phone: 805-278-4148
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Palo Alto, California 94304
Principal Investigator: Melaine Lising
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Pasadena, California 91105
Principal Investigator: Richard Shubin
Phone: 818-332-7986
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Pembroke Pines, Florida 33026
Principal Investigator: Margarita Almeida El-Ramey
Phone: 9548740201
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Jay Schneider
Phone: 215-503-0370
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
Principal Investigator: Nabila Dahodwala
Phone: 215-829-5254
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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Phoenix, Arizona 85013
Principal Investigator: Ryan Walsh
Phone: 602-406-8284
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Reseda, California 91335
Principal Investigator: Robert Hutchman
Phone: 818-654-9700
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Sacramento, California 95817
Principal Investigator: Lin Zhang
Phone: 916-734-6523
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Susan R Criswell
Phone: 314-362-6908
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Scarborough, Maine 04074
Principal Investigator: Michael Kleinman
Phone: 207-883-1414
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
Principal Investigator: Shyamai Mehta
Phone: 480-301-6328
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Springfield, New Jersey 07081
Principal Investigator: ROGER KURLAN
Phone: 973-850-4622
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Stamford, Connecticut 06905
Principal Investigator: Peter J McAllister
Phone: 203-914-1903
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Sun City, Arizona 85351
Principal Investigator: David Shprecher
Phone: 623-832-6500
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Tampa, Florida 33609
Principal Investigator: SUSAN STEEN
Phone: 813-353-9613
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Toms River, New Jersey 08755
Principal Investigator: Ashok Patel
Phone: 732-244-2299
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1 Valleybrook Drive
Toronto, Ontario M3B 2S7
Principal Investigator: Sharon Cohen
Phone: 4163869761
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1295 North Martin Avenue
Tucson, Arizona 85724
Principal Investigator: Scott Sherman
Phone: 520-626-6524
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Vernon, Connecticut 06066
Principal Investigator: J. Antonelle de Marcaida
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Virginia Beach, Virginia 23456
Principal Investigator: Karen Thomas
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Fernando Pagan
Phone: 202-444-6087
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Willow Grove, Pennsylvania 19090
Principal Investigator: David C Weisman
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Winfield, Illinois 60190
Principal Investigator: Zoran Grujic
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Mustafa Siddiqui
Phone: 336-716-8694
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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