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 | 
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.
			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
    sites
	
									8940 North Kendall Drive
Miami, Florida 33176
	
			
					Miami, Florida 33176
Principal Investigator: Victor Faradji
			
						
										Phone: 305-595-4041
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									201 Dowman Dr
Atlanta, Georgia 30303
	
			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
	
			Birmingham, Alabama 35233
(205) 934-4011  
							 
					Principal Investigator: Amy Amara
			
						
										Phone: 205-934-2402
					
		University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...  
  
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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
	
			Houston, Texas 77030
(713) 798-4951 
							 
					Principal Investigator: Joohi Jimenez-Shahed
			
						
										Phone: 713-798-7438
					
		Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...  
  
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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
	
			
					Miami, Florida 33144
Principal Investigator: Bruno Gallo
			
						
										Phone: 305-631-6704
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									104 SE 1st Avenue
Ocala, Florida 34471
	
			Ocala, Florida 34471
352-629-5800
							 
					Principal Investigator: Anette V. Nieves
			
						
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									100 West Gore St # 202
Orlando, Florida 32806
	
			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
	
			
					Ormond Beach, Florida 32174
Principal Investigator: James Scott
			
						
										Phone: 386-676-6340
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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
	
			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
	
			Atlanta, Georgia 30308
(404) 881-5800
							 
					Principal Investigator: Robert Alan Riesenberg
			
						
										Phone: 4048815800
					
		Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...  
  
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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
	
			Aurora, Colorado 80045
720-848-0000
							 
					Principal Investigator: Samantha Holden
			
						
										Phone: 303-724-8225
					
		University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...  
  
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								Bellevue, Washington 98007			
	
			
					Principal Investigator: Arifulla Khan
			
						
										Phone: 425-453-0404
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								Boca Raton, Florida 33486			
	
			
					Principal Investigator: Stuart H Isaacson
			
						
										Phone: 561-392-1818
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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
	
			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
	
			Chicago, Illinois 60612
(312) 942-5000 
							 
					Principal Investigator: Jennifer Goldman
			
						
										Phone: 480-256-6444
					
		Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...  
  
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								Dallas, Texas 75231			
	
			
					Principal Investigator: Nirav Pavasia
			
						
										Phone: 214-750-9977
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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
			
						
										Phone: 303-357-5445
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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
			
						
										Phone: 714-378-5062
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									92 Broad Street
Glens Falls, New York 12801
	
			
					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
			
						
										Phone: 717-531-7670
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									340 W 10th St #6200
Indianapolis, Indiana 46202
	
			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
			
						
										Phone: 425-899-5385
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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
	
			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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									354 Merrimack Street
Methuen, Massachusetts 01844
	
			
					Methuen, Massachusetts 01844
Principal Investigator: Marc Shay
			
						
										Phone: 978-687-2321
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								Naples, Florida 34102			
	
			
					Principal Investigator: John D. Campbell
			
						
										Phone: 239-262-8971
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									4701 Ogletown-Stanton Road
Newark, Delaware 19713
	
			
					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
			
						
										Phone: 650-723-6469
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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
	
			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
	
			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
	
			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
	
			Scottsdale, Arizona 85259
(480) 515-6296
							 
					Principal Investigator: Shyamai Mehta
			
						
										Phone: 480-301-6328
					
		Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...  
  
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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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								Toms River, New Jersey 08755			
	
			
					Principal Investigator: Ashok Patel
			
						
										Phone: 732-244-2299
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									1 Valleybrook Drive
Toronto, Ontario M3B 2S7
	
			
					Toronto, Ontario M3B 2S7
Principal Investigator: Sharon Cohen
			
						
										Phone: 4163869761
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									1295 North Martin Avenue
Tucson, Arizona 85724
	
			
					Tucson, Arizona 85724
Principal Investigator: Scott Sherman
			
						
										Phone: 520-626-6524
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								Vernon, Connecticut 06066			
	
			
					Principal Investigator: J. Antonelle de Marcaida
			
						
										Phone: 860-870-6385
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								Virginia Beach, Virginia 23456			
	
			
					Principal Investigator: Karen Thomas
			
						
										Phone: 757-507-0600
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									3800 Reservoir Rd NW
Washington, District of Columbia 20007
	
			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
			
						
										Phone: 215-957-9250
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								Winfield, Illinois 60190			
	
			
					Principal Investigator: Zoran Grujic
			
						
										Phone: 630-933-4056
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									1 Medical Center Blvd
Winston-Salem, North Carolina 27157
	
			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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