Clinical trial NCT05307692: A Study of Seltorexant in Participants With Probable Alzheimer's Disease
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, and Clinical Efficacy of Seltorexant (JNJ-42847922) on Behavioral and Psychological Symptoms of Dementia in Patients With Probable Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 88
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of seltorexant versus placebo on the sum of Agitation and Aggression domain scores (A plus A) of the Neuropsychiatric Inventory-Clinician rating (NPI-C) in participants with probable Alzheimer's Disease (AD) with clinically significant agitation/aggression.


Eligibility criteria: Inclusion Criteria:

* Participant has received a diagnosis of probable Alzheimer Disease (AD) (Diagnostic and Statistical Manual of Mental Disorders-5 \[DSM-5\]) with the following characteristics at screening: Clinical Dementia Rating (CDR) global score greater than 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 on International Psychogeriatric Association (IPA) consensus clinical and research definition 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 screening and baseline with no more than 35 percent (%) of improvement in NPI-12 A/A domain score from the screening to baseline assessments
* Female participants must be postmenopausal before study entry (amenorrhea for at least 12 months)
* Body Mass Index (BMI) within the range 18-40 kilograms per square meter (kg/m\^2) (inclusive)

Exclusion Criteria:

* Participant fulfils diagnostic criteria for non-Alzheimer's Dementia: example, Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), and post-stroke dementia, based on clinical history. (Participants may be included with mixed AD/vascular dementia)
* Participant has a clinically significant acute illness within 7 days prior to study intervention 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 as pain) or significant history of aggression prior to dementia based on investigator judgment
* Participants who are not stable on concomitant medications or take prohibited medications

Primary outcomes:
measure: Change From Baseline in Neuropsychiatric Inventory Clinician Version (NPI-C) Sum of Agitation and Aggression Domain Scores (NPI-C A+A) at Day 43: Analyzed Under Estimand 1
timeFrame: Baseline (Day 1) and Day 43
measure: Change From Baseline in NPI-C A+A at Day 43: Analyzed Under Estimand 2
timeFrame: Baseline (Day 1) and Day 43
Secondary outcomes:
measure: Change From Baseline in Cohen-Mansfield Agitation Inventory- Community Version (CMAI-C) Total Score at Day 43
timeFrame: Baseline (Day 1) and Day 43
measure: Change From Baseline in Sleep Disorder Inventory (SDI) Average Total Score at Day 43
timeFrame: Baseline and Day 43
measure: Observed Plasma Concentrations of Seltorexant and Its Metabolite (M12)
timeFrame: Either Day 15 (8 and 14 hours post dose on night of Day 14) or Day 43 (8 and 14 hours post dose on night of Day 42)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Medical Advancement Center of Arizona
state: Arizona
city: Lafayette
country: United States
facility: Sunwise Clinical Research
state: California
city: Homestead
country: United States
facility: Luminous Clinical Research
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Center Inc.
state: Florida
city: Miami
country: United States
facility: Global Medical Institutes
state: Florida
city: Miami
country: United States
facility: Office of Emilio Mantero-Atienza, MD
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute (ABRI), Inc
state: Florida
city: Miami
country: United States
facility: Quantix Research
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Florida International Research Center (FIRC)
state: Florida
city: Miami
country: United States
facility: P&S Research, LLC
state: Florida
city: Miami
country: United States
facility: IMIC Inc
state: Florida
city: Miami
country: United States
facility: Biovision Medical
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Seminole
country: United States
facility: Accel Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Sonar Clinical Research
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Cypress
country: United States
facility: Gill Neuroscience
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Bennington
country: United States
facility: Memory Clinic Inc
state: Vermont
Study officials:
affiliation: Janssen Research and Development LLC
name: Janssen Research and Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: