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AZD3293 in Early Alzheimer's Disease (AMARANTH)

Active, not recruiting

This clinical trial will assess the efficacy and safety of AZD3293, compared with a placebo, as a possible treatment for early Alzheimer´s disease.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years Both No
September 2014
August 2019
1551

  • Gradual and progressive change in memory during the past 6 months or more reported by participant and study partner
  • Mini Mental State Examination Score of 21-28 inclusive at screening
  • Objective impairment in memory and functioning, as evaluated by memory test and functional measure performed at screening visit
  • Meets National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's disease or mild cognitive impairment (MCI) due to Alzheimer's

  • Significant neurological disease affecting the central nervous system, other than Alzheimer's, that may affect cognition or ability to complete the study, including but not limited to other dementias, serious brain infection, Parkinson´s disease, or epilepsy or recurrent seizures
  • History of clinically evident stroke or multiple strokes, based on history or imaging results
  • History of clinically important carotid or vertebrobasilar stenosis or plaque
  • History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
  • Major depression or any other psychiatric diagnosis that, in the judgment of the investigator, is likely to confuse study results or affect the participant's ability to complete the study
  • History of alcohol or drug abuse or dependence (except nicotine dependence) within the past 2 years
  • Within 1 year before the screening visit or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, NYHA class III or IV; hospitalization for or symptom of unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (for example, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
  • Congenital QT prolongation
  • History or presence of diabetes, unless disease and serum glucose levels are well controlled and actively managed
  • History of cancer within the last 5 years, with the exception of nonmetastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or nonprogressive prostate cancer
  • Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study; may include hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders

This Phase II-III study will test the hypothesis that AZD3293 is a disease-modifying treatment for people with early Alzheimer´s disease. Participants will be randomly assigned to take either the study drug or a placebo, a tablet taken once daily, for 2 years. Two different doses will be tested. AZD3293 is a BACE inhibitor, a type of drug that blocks the enzyme beta secretase. This enzyme is involved in the production of beta amyloid, a protein that accumulates into harmful plaques in the brain of people with Alzheimer's disease.

To be included in the study, participants will undergo either a positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid (CSF) sampling to document the presence of abnormal levels of beta amyloid. The study includes two substudies; participants who have a PET scan at screening will be included in the PET substudy, and those who have a lumbar puncture will be included in the CSF substudy.

For more information about this clinical trial, please contact Eli Lilly at 1-877-285-4559 or 1-317-615-4559. Refer to ClinicalTrial.gov number NCT02245737.

Name City State Zip Status Primary Contact
Banner Alzheimer's Institute
Phoenix Arizona 85006
602-839-6230
St Josephs Hospital and Medical Center
Phoenix Arizona 85013
602-406-4032
Banner Sun Health Research Institute
Sun City Arizona 85351
623-832-6530
Territory Neurology & Research Institute
Tucson Arizona 85704
520-388-5927
Positron Research International
Fremont California 94538
415-595-8687
Alliance Research Centers
Laguna Hills California 92653
949-680-3490
Senior Clinical Trials, Inc.
Laguna Hills California 92653
949-588-0909
Collaborative Neuroscience Network - CNS
Long Beach California 90806
866-669-4257
Pacific Research Network Inc
San Diego California 92103
619-294-4302
San Francisco Clinical Research Center
San Francisco California 94109

Mile High Research Center
Denver Colorado 80218
303-839-9900
Institute for Neurodegenerative Disorders
New Haven Connecticut 06510
203-401-4300
Georgetown University Medical Center
Washington District of Columbia 20057
202-687-7337
Howard University Hospital
Washington District of Columbia 20060
202-865-3776
Brain Matters Research
Delray Florida 33445
561-374-8461
Direct Helpers Medical Center
Hialeah Florida 33012
305-828-3555
Berma Research
Hialeah Florida 33016
305-456-7579
Galiz Research
Hialeah Florida 33016
305-820-3381
MaxBlue Institute
Hialeah Florida 33018
561-314-8524
Alzheimer's Research and Treatment Center
Lake Worth Florida 33449
561-209-2400
Miami Jewish Home and Hospital for the Aged
Miami Florida 33137
305-514-8503
Medical Research Center
Miami Florida 33144
305-846-7903
Unlimited Medical Research LLC
Miami Florida 33144

Allied Biomedical Research Institute, Inc.
Miami Florida 33155
305-643-8400
Advance Medical Research Institute
Miami Florida 33174
305-554-6198
New Horizon Research Center
Miami Florida 33175
305-226-3933
JDH Medical Group, LLC
Miami Florida 33186
305-961-1671
Compass Research
Orlando Florida 32162
407-426-9299
IMIC, Inc.
Palmetto Florida 33157
786-310-7477
Suncoast Neuroscience Associates
Saint Petersburg Florida 33713
727-202-2623
Roskamp Institute
Sarasota Florida 34243
941-256-8018
Infinity Clinical Research . LLC
Sunrise Florida 33351
954-475-8171
Olympian Clinical Research
Tampa Florida 33609
813-879-6040
Stedman Clinical Trials
Tampa Florida 33613
813-971-8311
Compass Research
The Villages Florida 32162
407-426-9299
Premiere Research Institute at Palm Beach Neurology
West Palm Beach Florida 33407
561-845-0500
The Multiple Sclerosis Center of Atlanta
Atlanta Georgia 30327
404-351-0205
Atlanta Center of Medical Research
Atlanta Georgia 30331
404-881-5800
Carmen Research
Smyrna Georgia 30080
770-333-0093
University of Chicago Medical Center
Chicago Illinois 60637
773-834-3470
Alexian Brothers Medical Center
Elk Grove Village Illinois 60007
847-593-8553
Community Clinical Research Center
Anderson Indiana 46011
317-963-7402
Indiana University Health
Indianapolis Indiana 46202
317-274-8393
ActivMed Practices and Research, Inc
Methuen Massachusetts 01844
978-655-7155
Boston Center for Memory
Newton Massachusetts 02459
617-699-6927
Springfield Neurology Associates
Springfield Massachusetts 01104
413-781-5045
Hattiesburg Clinic
Hattiesburg Mississippi 39401
601-268-5620
Millennium Psychiatric Associates, LLV
St. Louis Missouri 63141
314-298-0001
St. Louis Clinical Trials, LC
St. Louis Missouri 63141
314-558-4334
Memory Enhancement Center of America, Inc.
Eatontown New Jersey 07724
732-263-0101
AdvanceMed Research
Lawrenceville New Jersey 08648
609-895-0735
Alzheimer's Research Company
Manchester New Jersey 08759
732-657-6100
The Cognitive and Research Center of NJ
Springfield New Jersey 07081
973-850-4622
Bio Behavioral Health
Toms River New Jersey 08755
732-244-2299
Advanced Memory Research Institute of New Jersey
Toms River New Jersey 08755
732-341-9500
Neurology Specialists of Monmouth County
West Long Branch New Jersey 07764
732-935-1850
Integrative Clinical Trials, LLC
Brooklyn New York 11229
718-444-7774
SPRI Clinical Trials, LLC
Brooklyn New York 11235
718-616-2250
Alzheimer's Disease and Memory Disorders Center
Buffalo New York 14203
716-888-4722
Empire Neurology, PC
Latham New York 12110
518-785-1000
Clinilabs, Inc (New York)
New York New York 10019
646-215-6459
Columbia University Medical Center
New York New York 10032
212-305-9194
University of Rochester
Rochester New York 14620
585-760-6560
Alzheimer's Memory Center
Charlotte North Carolina 28270
704-364-4000
Valley Medical Research
Centerville Ohio 45459
937-208-8298
Christ Hospital
Cincinnati Ohio 45219
513-585-1777
The Ohio State University
Columbus Ohio 43210
513-558-4050
The Corvallis Clinic P.C.
Corvallis Oregon 97330
541-754-1398
Lehigh Valley Hospital
Allentown Pennsylvania 18103
610-402-9008
Rhode Island Mood & Memory Research Institute
East Providence Rhode Island 02914
401-435-8950
Roper St. Francis Healthcare
Charleston South Carolina 29401
843-724-2302
Radiant Research
Greer South Carolina 29650
864-877-9239
Alzheimers Research and Clinical Programs
North Charleston South Carolina 29406
843-724-2302
Quillen College of Medicine, East TN State University
Johnson City Tennessee 37604
423-439-2211
Senior Adults Specialty Research Inc
Austin Texas 78757
512-407-8628
Texas Neurology, PA
Dallas Texas 75214
801-288-0607
Texas Health Physicians Group
Dallas Texas 75231
214-345-4449
Medical Group of Texas
Ft Worth Texas 76104
817-348-8292
University of Texas Health Services Center - Houston
Houston Texas 77054
713-486-0500
University of Utah School of Medicine
Salt Lake City Utah 84108
801-585-6546
The Memory Clinic
Bennington Vermont 05201
802-447-1409
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AstraZeneca

Name Phone Email
Eli Lilly 1-877-285-4559

NCT02245737

A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)