A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia



Status:Terminated
Conditions:Alzheimer Disease, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 85
Updated:10/28/2018
Start Date:July 1, 2016
End Date:September 28, 2018

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A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

The main purpose of this study is to evaluate the efficacy of the study drug known as
lanabecestat in participants with mild Alzheimer's disease (AD) dementia.


Inclusion Criteria:

- Participant must meet the National Institute on Aging (NIA) and the Alzheimer's
Association (AA) (NIA-AA) criteria for probable AD dementia.

- MMSE score of 20 to 26 inclusive at screening visit.

- For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5
or 1, with the memory box score ≥0.5 at screening.

- Evidence of amyloid pathology.

- The participant must have a reliable study partner with whom he/she cohabits or has
regular contact.

Exclusion Criteria:

- Significant and/or current neurological disease affecting the central nervous system,
other than AD, that may affect cognition or ability to complete the study, including
but not limited to, other dementias, repetitive head trauma, serious infection of the
brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.

- Participants with any current primary psychiatric diagnosis other than AD if, in the
judgment of the investigator, the psychiatric disorder or symptom is likely to
confound interpretation of drug effect, affect cognitive assessment, or affect the
participant's ability to complete the study. Participants with history of
schizophrenia or other chronic psychosis are excluded.

- Within 1 year before the screening visit or between screening and randomization, any
of the following: myocardial infarction; moderate or severe congestive heart failure,
New York Heart Association class III or IV; hospitalization for, or symptoms of,
unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known
significant structural heart disease (such as, significant valvular disease,
hypertrophic cardiomyopathy); or hospitalization for arrhythmia.

- Congenital QT prolongation.

- Intermittent second- or third-degree atrioventricular (AV) heart block or AV
dissociation or history of ventricular tachycardia.

- A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at
screening (as determined at the investigational site).

- History of malignant cancer within the last 5 years.

- History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.

- Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula;
Cockcroft and Gault 1976) at screening.

- Currently enrolled in any other clinical trial involving an investigational product or
any other type of medical research judged not to be scientifically or medically
compatible with this study.
We found this trial at
91
sites
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Allan Levey
Phone: 404-727-7220
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
2178
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Atlanta, GA
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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
Principal Investigator: Janice Knebl
Phone: 817-735-2193
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Fort Worth, TX
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
Principal Investigator: Perminder Bhatia
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Fresno, CA
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Principal Investigator: Erin Doty
Phone: 904-730-0101
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Jacksonville, FL
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: B BAUMEL
Phone: 305-243-9068
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Principal Investigator: Craig Curtis
Phone: 407-426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Orlando, FL
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4235 Kings Highway
Port Charlotte, Florida 33952
Principal Investigator: Ramon Gil
Phone: 941-743-4987
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Brian Ott
Phone: 401-444-6440
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Sarasota, Florida 34232
Principal Investigator: Mauricio Concha
Phone: 941-330-1864
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
Principal Investigator: Michael Badruddoja
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1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
Principal Investigator: Paul Murphy
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Principal Investigator: Robert Riesenberg
Phone: 404-881-5800
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 Goldstein
Phone: 561-968-2933
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Principal Investigator: John Morgan
Phone: 706-721-2798
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Avon, Indiana
Principal Investigator: Mark Benson
Phone: 317-745-8000
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Avon, IN
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Clifford Singer
Phone: 207-973-9043
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Principal Investigator: Robert Stern
Phone: 617-638-5678
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Calgary, Alberta
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Carlsbad, California 92011
Principal Investigator: BENJAMIN FRISHBERG
Phone: 760-732-0557
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: David Clark
Phone: 843-792-3221
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28211
Principal Investigator: Oleg Tcheremissine
Phone: 704-446-7504
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Clearwater, Florida 33756
Principal Investigator: Diana Pollock
Phone: 727-443-3295
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Cleveland, Ohio 44122
Principal Investigator: Mary Manning
Phone: 212-682-0320
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Clinton, Utah 84015
Principal Investigator: Tyler Dixon
Phone: 801-614-5501
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Columbus, Georgia 31909
Principal Investigator: Jonathan Liss
Phone: 706-653-8455
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Columbus, Ohio 43210
Principal Investigator: Douglas Scharre
Phone: 614-293-8531
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Corvallis, Oregon 97330
Principal Investigator: Weijia Wang
Phone: 541-754-1150
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Costa Mesa, California 92626
Principal Investigator: Roginelli Yu
Phone: 714-668-1500
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Danbury, Connecticut 06810
Principal Investigator: Samuel Markind
Phone: 203-748-2551
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Delray Beach, Florida 33445
Principal Investigator: Mark Brody
Phone: 561-374-8461
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Delray Beach, Florida 33446
Principal Investigator: Robert Cohen
Phone: 561-496-7200
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East Lansing, Michigan 48824
Principal Investigator: Andrea Bozoki
Phone: 517-884-2482
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East Providence, Rhode Island 02914
Principal Investigator: John Stoukides
Phone: 401-435-8950
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Fairway, Kansas 66205
Principal Investigator: Jeffrey Burns
Phone: 913-588-0555
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Fort Myers, Florida 33912
Principal Investigator: Frederick Schaerf
Phone: 239-939-7777
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Fullerton, California 92835
Principal Investigator: Johnson Moon
Phone: 714-879-7200
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Greer, South Carolina
Principal Investigator: William Ellison
Phone: 864-877-9239
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Hattiesburg, Mississippi 39401
Principal Investigator: Ronald Schwartz
Phone: 601-268-5620
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Hialeah, Florida 33012
Principal Investigator: Jose Cardona
Phone: 305-827-3335
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Hollywood, Florida 33021
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Honolulu, Hawaii 96817
Principal Investigator: Kore Liow
Phone: 808-261-4476
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Indianapolis, Indiana 46256
Principal Investigator: KRISTI GEORGE
Phone: 317-537-6060
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Jacksonville, Florida 32216
Principal Investigator: Neil Graff-Radford
Phone: 904-953-7103
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Jenkintown, Pennsylvania 19046
Principal Investigator: Marvin Kalafer
Phone: 215-884-1700
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Jonesboro, Arkansas 72401
Principal Investigator: Kenneth Chan
Phone: 870-934-1006
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Kingsport, Tennessee 37660
Principal Investigator: David Morin
Phone: 423-578-1546
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Las Vegas, Nevada 89113
Principal Investigator: Bharat Mocherla
Phone: 310-993-9118
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Lexington, Kentucky 40513
Principal Investigator: Gregory Anderson
Phone: 859-685-0684
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166 Pasadena Drive
Lexington, Kentucky 40503
Principal Investigator: Greg Cooper
Phone: 859-260-4330
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Madison, Wisconsin 53715
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Meridian, Idaho 83642
Principal Investigator: Mark Turner
Phone: 208-377-8653
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Merritt Island, Florida 32955
Principal Investigator: Gregory Kirk
Phone: 321-848-0770
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Miami, Florida 33155
Principal Investigator: Michael Pfeffer
Phone: 305-643-8400
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Muncie, Indiana 47304
Principal Investigator: Jonathan Condit
Phone: 801-365-1032
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: CHRIS VAN DYCK
Phone: 203-764-8100
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, Connecticut 06510
Principal Investigator: David Russell
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New York, New York 10021
Principal Investigator: Melanie Shulman
Phone: 212-263-5845
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Norristown, Pennsylvania 19401
Principal Investigator: Robert Pearlstein
Phone: 610-270-9571
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Norwalk, Connecticut 06851
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Oklahoma City, Oklahoma 73116
Principal Investigator: Willis Holloway
Phone: 405-603-8068
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Principal Investigator: Carl Griffin
Phone: 405-602-3939
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Oxnard, California
Principal Investigator: James Sutton
Phone: 805-278-4148
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Phoenix, Arizona 85004
Principal Investigator: Stephen Flitman
Phone: 602-274-9500
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: Marwan Sabbagh
Phone: 602-406-4784
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Plymouth, Massachusetts 02360
Principal Investigator: Donald Marks
Phone: 508-746-5060
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Pompano Beach, Florida 33064
Principal Investigator: Jose De La Gandara
Phone: 954-786-7331
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Port Royal, South Carolina 29935
Principal Investigator: Paul Mazzeo
Phone: 843-522-1420
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Portland, Oregon 97210
Principal Investigator: Scott Losk
Phone: 503-972-9833
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345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Principal Investigator: Stephen Salloway
Phone: 401-455-6403
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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Raleigh, North Carolina 27607
Principal Investigator: Bradley Robottom
Phone: 919-782-3456
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1040 North Mason Road
Saint Louis, Missouri 63141
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San Antonio, Texas 78238
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San Diego, California 92103
Principal Investigator: D BRANDON
Phone: 619-291-2321
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San Diego, California 92103
Principal Investigator: Stephen Thein
Phone: 619-294-4302
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San Diego, California 92123
Principal Investigator: MICHAEL PLOPPER
Phone: 858-836-8355
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Santa Ana, California 92705
Principal Investigator: John Duffy
Phone: 714-542-3008
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Santa Clarita, California 91321
Principal Investigator: Surisham Dhillon
Phone: 661-388-0430
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Scarborough, Maine 04074
Principal Investigator: Eric Dinnerstein
Phone: 207-883-1414
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Scottsdale, Arizona 85258
Principal Investigator: Constantine Moschonas
Phone: 480-614-0707
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Scottsdale, Arizona 85260
Principal Investigator: Dennis Swearingen
Phone: 480-718-9241
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Shaker Heights, Ohio 44122
Principal Investigator: Deborah Gould
Phone: 216-526-1843
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Sherman Oaks, California 91403
Principal Investigator: THOMASSHIOVITZ THOMAS SHIOVITZ
Phone: 818-990-2671
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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: Sanjiv Sharma
Phone: 732-341-9500
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Topeka, Kansas 66606
Principal Investigator: Scott Teeter
Phone: 785-368-0744
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Valencia, California 91355
Principal Investigator: Mehdi Meratee
Phone: 661-388-0397
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West Long Branch, New Jersey 07764
Principal Investigator: Noah Gilson
Phone: 732-935-1850
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Winchester, Massachusetts 01890
Principal Investigator: Anil Nair
Phone: 617-639-5006
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
Principal Investigator: Giles Crowell
Phone: 336-794-8165
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Principal Investigator: Kaycee Sink
Phone: 336-713-8558
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