Phase
Condition
N/ATreatment
Seltorexant
Placebo
Clinical Study ID
Ages 55-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has received a diagnosis of probable Alzheimer Disease (AD) (Diagnosticand Statistical Manual of Mental Disorders-5 [DSM-5]) with the followingcharacteristics at screening: Clinical Dementia Rating (CDR) global score greaterthan or equal to (>=) 1; Mini-Mental State Examination (MMSE) total score of 10 to 24 (inclusive)
Participant meets the criteria of a syndrome diagnosis of agitation based onInternational Psychogeriatric Association (IPA) consensus clinical and researchdefinition of agitation in cognitive disorders for at least 2 weeks before screening
Participant meets the criteria of Neuropsychiatric Inventory (NPI-12)Agitation/Aggression (A/A) domain score >= 4 with frequency score >= 2 at screeningand baseline with no more than 35 percent (%) of improvement in NPI-12 A/A domainscore from the screening to baseline assessments
Female participants must be postmenopausal before study entry (amenorrhea for atleast 12 months)
Body Mass Index (BMI) within the range 18-40 kilograms per square meter (kg/m^2) (inclusive)
Exclusion
Exclusion Criteria:
Participant fulfils diagnostic criteria for non-Alzheimer's Dementia: example,Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), and post-strokedementia, based on clinical history. (Participants may be included with mixedAD/vascular dementia)
Participant has a clinically significant acute illness within 7 days prior to studyintervention administration
Participants with a history of delirium within 30 days prior to or during screening
Participant with a cause of agitation that is not secondary to dementia (such aspain) or significant history of aggression prior to dementia based on investigatorjudgment
Participants who are not stable on concomitant medications or take prohibitedmedications
Study Design
Connect with a study center
Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
Kharkiv, 61068
UkraineSite Not Available
Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)
Kyiv, 02192
UkraineSite Not Available
Onyx Clinical Research
Peoria, Arizona 85381
United StatesSite Not Available
Medical Advancement Center of Arizona
Phoenix, Arizona 85051
United StatesSite Not Available
Medical Advancement Center of Arizona
Tempe, Arizona 85283
United StatesSite Not Available
Advanced Research Center Inc
Anaheim, California 92805
United StatesSite Not Available
Sunwise Clinical Research
Lafayette, California 94549
United StatesSite Not Available
Luminous Clinical Research
Homestead, Florida 33030
United StatesSite Not Available
Allied Biomedical Research Institute (ABRI), Inc
Miami, Florida 33155-4630
United StatesSite Not Available
Biovision Medical
Miami, Florida 33184
United StatesSite Not Available
Entrust Clinical Research
Miami, Florida 33156
United StatesSite Not Available
Florida International Research Center (FIRC)
Miami, Florida 33173
United StatesSite Not Available
Global Medical Institutes
Miami, Florida 33125
United StatesSite Not Available
IMIC Inc
Miami, Florida 33176
United StatesSite Not Available
IMIC, Inc.
Miami, Florida 33176
United StatesSite Not Available
Office of Emilio Mantero-Atienza, MD
Miami, Florida 33135
United StatesSite Not Available
P&S Research, LLC
Miami, Florida 33175
United StatesSite Not Available
Quantix Research
Miami, Florida 33155
United StatesSite Not Available
South Florida Research Center Inc.
Miami Springs, Florida 33166
United StatesSite Not Available
Neurology Associates of Ormond Beach
Ormond Beach, Florida 32174
United StatesSite Not Available
IMIC, Inc.
Palmetto Bay, Florida 33157
United StatesSite Not Available
Accel Clinical Research
Saint Petersburg, Florida 33709
United StatesSite Not Available
Intercoastal Medical Group
Sarasota, Florida 34239
United StatesSite Not Available
Accel Clinical Research
Seminole, Florida 33777
United StatesSite Not Available
Meridien Research
Tampa, Florida 33634
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesSite Not Available
NeuroTrials Research Inc
Atlanta, Georgia 30328
United StatesSite Not Available
Sonar Clinical Research
Atlanta, Georgia 30315
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40506
United StatesSite Not Available
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Boston Clinical Trials
Boston, Massachusetts 02131
United StatesSite Not Available
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
United StatesSite Not Available
Onyx Clinical Research
Flint, Michigan 48532
United StatesSite Not Available
Mid Hudson Medical Research
New Windsor, New York 12572
United StatesSite Not Available
Richmond Behavioral Associates
Staten Island, New York 10312
United StatesSite Not Available
Stony Brook University Medical Center
Stony Brook, New York 11794
United StatesSite Not Available
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Gill Neuroscience
Cypress, Texas 77429
United StatesSite Not Available
Wasatch Clinical Research
Salt Lake City, Utah 84107
United StatesSite Not Available
Memory Clinic Inc
Bennington, Vermont 05201
United StatesSite Not Available
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