Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol



Status:Recruiting
Conditions:Alzheimer Disease, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:55 - 90
Updated:2/28/2019
Start Date:October 2016
End Date:October 2021
Contact:ADNI Central Phone Number
Email:adni3-participate@usc.edu
Phone:888-2-ADNI-95 (888-223-6495)

Use our guide to learn which trials are right for you!

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD.
ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been
combined public/private collaborations between academia and industry to determine the
relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker
characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the
study is to continue to discover, optimize, standardize, and validate clinical trial measures
and biomarkers used in AD research.

The overall goal of ADNI3 is to determine the relationships among the clinical, cognitive,
imaging, genetic and biochemical biomarker characteristics of the entire spectrum of
Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild
symptoms, to mild cognitive impairment (MCI), to dementia. ADNI3 continues the previously
funded AD Neuroimaging Initiative (ADNI1, ADNI-GO, and ADNI-2), and remains a public/private
collaboration between academia and industry to study biomarkers of AD. ADNI will continue to
inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome
measures that can be used in clinical trials, and help develop the most effective clinical
trial scenarios.

This is multi-center, a non-randomized, natural history, non-treatment study. 1,070-2,000
total participants will be enrolled across three cohorts: cognitively normal* (CN), mild
cognitive impairment (MCI) and mild Alzheimer's Disease (AD) dementia. Participants between
the ages of 55-90 (inclusive) will be enrolled at 59 sites in the United States and Canada.
Approximately, 700 - 800 will be rollover participants from previous ADNI studies, and 370 -
1200 will be newly enrolled. Clinical/cognitive, imaging, biomarker, and genetic
characteristics will be assessed across the three cohorts.

Participants will undergo longitudinal clinical and cognitive assessments, computerized
cognitive batteries, biomarker and genetic tests, PET (FDG, amyloid and tau) and MRI scans
and cerebral spinal fluid (CSF) collection for up to 5 years.

*currently recruiting non-Caucasian participants only for the cognitively normal cohort.

Inclusion Criteria (all CN participants):

1. Participant with or without subjective memory complaints, verified by a study partner,
beyond what one would expect for age

2. Normal memory function documented by scoring above education adjusted cutoffs on the
Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the
Wechsler Memory Scale -Revised (the maximum score is 25):

1. 9 for 16 or more years of education

2. 5 for 8-15 years of education

3. 3 for 0-7 years of education

3. Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for
participants with less than 8 years of education at the discretion of the Project
Director)

4. Clinical Dementia Rating = 0. Memory Box score must be 0

5. Cognitively normal, based on an absence of significant impairment in cognitive
functions or activities of daily living

6. Stability of Permitted Medications for at least 4 weeks:

1. Stable doses of antidepressants lacking significant anticholinergic side effects
(if they are currently adequately treated for depressive symptoms and do not have
a history of major depression within the past 1 years)

2. Estrogen replacement therapy is permissible

3. Gingko biloba is permissible, but discouraged

4. Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening.

Inclusion Criteria (all MCI participants):

1. Participant must express a subjective memory concern as reported by participant, or
recalled by study partner or clinician.

2. Abnormal memory function documented by scoring below education adjusted cutoffs on the
Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the
Wechsler Memory Scale -Revised (the maximum score is 25):

a. < 11 for 16 or more years of education b. ≤ 9 for 8-15 years of education c. ≤ 6
for 0-7 years of education

3. Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for
participants with less than 8 years of education at the discretion of the Project
Director)

4. Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5

5. General cognition and functional performance sufficiently preserved such that a
diagnosis of Alzheimer's disease cannot be made by the site physician at the time of
the Screening Visit

6. Stability of Permitted Medications for at least 4 weeks:

1. Stable doses of antidepressants lacking significant anticholinergic side effects
(if they are currently adequately treated for depressive symptoms and do not have
a history of major depression within the past 1 years)

2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks
prior to Screening Visit

3. Estrogen replacement therapy is permissible

4. Gingko biloba is permissible, but discouraged

5. Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening.

Inclusion Criteria (all AD participants):

1. Participant must express a subjective memory concern as reported by participant, or
recalled by study partner or clinician.n.

2. Abnormal memory function documented by scoring below education adjusted cutoffs on the
Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the
Wechsler Memory Scale -Revised (the maximum score is 25):

1. ≤ 8 for 16 or more years of education

2. ≤ 4 for 8-15 years of education

3. ≤ 2 for 0-7 years of education

3. Mini-Mental State Exam score between 20 and 24 inclusive (Exceptions for scores of 24
and 25 may be made for participants with less than 8 years of education at the
discretion of the Project Director)

4. Clinical Dementia Rating = 0.5 or 1.0

5. NINCDS (National Institute of Neurological and Communicative Disorders and Stroke)
-ADRDA (Alzheimer's Disease and Related Disorders Association) criteria for probable
AD

6. Stability of Permitted Medications for at least 4 weeks:

1. Stable doses of antidepressants lacking significant anticholinergic side effects
(if they are currently adequately treated for depressive symptoms and do not have
a history of major depression within the past 1 years)

2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks
prior to Screening Visit

3. Estrogen replacement therapy is permissible

4. Gingko biloba is permissible, but discouraged

5. Washout from psychoactive medication (e.g., excluded antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4
weeks prior to screening.

Inclusion Criteria Specific to Newly Enrolled Participants

1. Geriatric Depression Scale score less than 6.

2. Age between 55-90 years (inclusive).

3. Study partner who has frequent contact with the participant (i.e., minimum average of
10 hours per week) and is available to accompany the participant to all clinic visits
for the duration of the protocol.

4. Visual and auditory acuity adequate for neuropsychological testing.

5. Good general health with no diseases expected to interfere with the study.

6. Participant is not pregnant, lactating, or of childbearing potential (i.e. women must
be two years post-menopausal or surgically sterile).

7. Willing and able to participate in a longitudinal imaging study.

8. Modified Hachinski Ischemic Score less than or equal to 4.

9. Completed six grades of education or has a good work history (sufficient to exclude
mental retardation).

10. Must speak English or Spanish fluently.

11. Willing to undergo repeated MRIs (3Tesla) and at least two PET scans

12. Agrees to collection of blood for genomic analysis (including GWAS (genome-wide
association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and
biospecimen banking.

13. Agrees to collection of blood for biomarker testing.

14. Agrees to at least one lumbar puncture for the collection of CSF.

15. Agrees to share genomic data and biomarker samples. Inclusion Criteria Specific to
Rollover Participants"

The following additional inclusion criteria apply to all diagnostic categories for rollover
participants only:

1. Must have been enrolled and followed in ADNI-1, ADNI-GO, or ADNI-2 for at least one
year.

2. Willing and able to continue to participate in an ongoing longitudinal study. A
reduced battery of tests is allowable if the participant is not able/willing to
complete the full battery.

Exclusion Criteria (all CN participants):

1. Any significant neurologic disease, such as Parkinson's disease, multi-infarct
dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor,
progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple
sclerosis, or history of significant head trauma followed by persistent neurologic
deficits or known structural brain abnormalities

Exclusion Criteria (all MCI participants):

1. Any significant neurologic disease other than suspected incipient Alzheimer's disease,
such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure
hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural
hematoma, multiple sclerosis, or history of significant head trauma followed by persistent
neurologic deficits or known structural brain abnormalities.

Exclusion Criteria (all AD participants):

1. Any significant neurologic disease other than Alzheimer's disease, such as Parkinson's
disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain
tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple
sclerosis, or history of significant head trauma followed by persistent neurologic deficits
or known structural brain abnormalities.

Exclusion Criteria (all participants):

The following additional exclusion criteria apply to all diagnostic categories:

1. Screening/Baseline MRI brain scan with evidence of infection, infarction, or other
focal lesions or multiple lacunes or lacunes in a critical memory structure

2. Subjects that have any contraindications for MRI studies, including the presence of
cardiac pacemakers, or metal fragments or foreign objects in the eyes, skin or body.

3. Major depression, bipolar disorder as described in DSM-IV within the past 1 year.
Psychotic features, agitation or behavioral problems within the last 3 months that
could lead to difficulty complying with the protocol.

4. Currently treated with medication for obsessive-compulsive disorder or attention
deficit disorder.

5. History of schizophrenia (DSM IV criteria).

6. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV
criteria).

7. Any significant systemic illness or unstable medical condition, which could lead to
difficulty complying with the protocol.

8. Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that
might interfere with the study. A low B12 is exclusionary, unless follow-up labs
(homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not
physiologically significant.

9. Residence in a skilled nursing facility.

10. Current use of specific psychoactive medications (e.g., certain antidepressants,
neuroleptics, chronic anxiolytics or sedative hypnotics). Current use of warfarin or
other anticoagulants such as dabigatran, rivaroxaban and apixaban (exclusionary for
lumbar puncture).

11. Current use of any other exclusionary medications

12. Investigational agents are prohibited one month prior to entry and for the duration of
the trial.

13. Participation in clinical studies involving neuropsychological measures being
collected more than one time per year.

Exclusion Criteria Specific to AV-1451 PET:

The following criteria are exclusionary only for the AV-1451 scanning portion of the study:

1. History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with
sudden death) or taking medications known to prolong the QT interval. A list of
restricted medications will be provided.

2. Have an ECG obtained prior to the AV-1451 PET scan that in the opinion of the
investigator is clinically significant with regard to the subject's participation in
the study. Bazett's corrected QT (QTcB) interval must be evaluated and must not exceed
458 msec in males, or 474 msec in females.
We found this trial at
55
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Allan Levey, MD, PhD
Phone: 404-712-0195
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Marilyn Albert, PhD
Phone: 443-287-0381
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: David Geldmacher, MD
Phone: 205-996-3679
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Gad Marshall, MD
Phone: 617-732-8085
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: Ron Killiany, PhD
Phone: 617-414-1077
Boston University School of Medicine A leader in medical education and research, Boston University School...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Joseph Kass, MD
Phone: 713-798-5328
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Martin Farlow, MD
Phone: 317-963-7426
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Delwyn Miller, MD
Phone: 319-353-5158
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Lon Schneider, MD
Phone: 323-442-7600
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Maryam Beigi, MD
Phone: 310-794-6191
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Paul Newhouse, MD
Phone: 615-875-0955
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Yaakov Stern, PhD
Phone: 212-342-0522
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-692-2721
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Lisa Silbert, MD, MCR
Phone: 503-494-0976
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Brian Ott, MD
Phone: 401-606-4664
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Anton Portseinsson, MD
Phone: 585-760-6569
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: David Hart, MD
Phone: 518-264-1130
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Ann Arbor, Michigan 48105
Principal Investigator: Judith Heidebrink, MD
Phone: 734-232-1199
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Beachwood, Ohio 44122
Principal Investigator: Alan Lerner, MD
Phone: 216-464-6474
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Buffalo, New York 14226
Principal Investigator: Horacio Capote, MD
Phone: 716-558-3492
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Charleston, South Carolina 29401
Principal Investigator: Abigail OConnell, MS APRN FNP-C
Phone: 843-724-2214
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Emily Rogalski, PhD
Phone: 312-503-2486
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Raj Shah, MD
Phone: 312-942-6596
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Douglas Scharre, MD
Phone: 614-293-6882
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Dallas, Texas 75390
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Phone: 214-648-9331
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Murali Doraiswamy, MBBS
Phone: 919-681-3986
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Fairway, Kansas 66205
Principal Investigator: Jeffrey Burns, MD, MS
Phone: 913-945-6792
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Houston, Texas 77030
Principal Investigator: Joseph Masdeu, MD, PhD
Phone: 713-441-9484
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Irvine, California 92697
949-824-5011
Principal Investigator: Gaby Thai, MD
Phone: 949-824-3250
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Jacksonville, Florida 32216
Principal Investigator: Neill Graff-Radford, MD
Phone: 904-953-3234
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: James Brewer, MD, PhD
Phone: 858-249-1329
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Las Vegas, Nevada 89106
Principal Investigator: Charles Bernick, MD, MPH
Phone: 702-701-7967
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Charles Smith, MD
Phone: 859-323-2737
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Long Beach, California 90822
Principal Investigator: Steven Potkin, MD
Phone: 562-826-8000
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Sterling Johnson, PhD
Phone: 608-262-4760
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Miami Beach, Florida 33140
Principal Investigator: Duara Ranjan, MD
Phone: 305-674-2121
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Christopher van Dyck, MD
Phone: 203-764-6797
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New York, New York 10021
Principal Investigator: Martin Sadowski, MD, PhD
Phone: 212-263-0771
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New York, New York 10029
Principal Investigator: Hillel Grossman, MD
Phone: 212-659-5621
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Orangeburg, New York 10962
Principal Investigator: Nunzio Pomara, MD
Phone: 845-398-6532
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3801 Miranda Avenue
Palo Alto, California 94304
Principal Investigator: Jerome Yesavage, MD
Phone: 650-493-5000
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: David Wolk, MD
Phone: 215-662-4379
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Phoenix, Arizona 85006
Principal Investigator: Allison Perrin, MD
Phone: 602-839-4617
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Phoenix, Arizona 85013
Principal Investigator: Jiong Shi, MD, PhD
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Providence, Rhode Island 02906
Principal Investigator: Stephen Salloway, MD, MS
Phone: 401-455-6403
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Ronald Peterson, MD, PhD
Phone: 507-293-4866
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Saint Louis, Missouri 63110
Principal Investigator: Beau Ances, MD
Phone: 314-286-2429
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San Francisco, California 94143
Principal Investigator: Howard Rosen, MD
Phone: 415-514-8745
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Sun City, Arizona 85351
Principal Investigator: Edward Zamrini, MD
Phone: 623-832-6527
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Tampa, Florida 33613
Principal Investigator: Amanda Smith, MD
Phone: 813-396-0637
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Vancouver, British Columbia
Principal Investigator: Robin Hsiung, MD
Phone: 604-822-7990
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Walnut Creek, California 94598
Principal Investigator: John Olichney, MD
Phone: 925-357-6914
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Washington, District of Columbia 20060
Principal Investigator: Thomas Obisesan, MD
Phone: 202-865-7895
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Principal Investigator: Brigid Reynolds, RN, MSN, NP
Phone: 202-687-3355
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Jeff Williamson, MD
Phone: 336-713-8477
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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