A Study of Seltorexant in Participants With Probable Alzheimer's Disease

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05307692
• Other study ID #: CR109177
• Secondary ID: 42847922ALZ2001
• Status: Completed
• Phase: Phase 2
• Start date: May 19, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: March 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Seltorexant
Seltorexant 20 mg will be administered orally as a tablet.
• Placebo
Matching placebo will be administered orally as a tablet.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	Sonar Clinical Research	Atlanta	Georgia
United States	Memory Clinic Inc	Bennington	Vermont
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Gill Neuroscience	Cypress	Texas
United States	Luminous Clinical Research	Homestead	Florida
United States	Sunwise Clinical Research	Lafayette	California
United States	Allied Biomedical Research Institute (ABRI), Inc	Miami	Florida
United States	Biovision Medical	Miami	Florida
United States	Entrust Clinical Research	Miami	Florida
United States	Florida International Research Center (FIRC)	Miami	Florida
United States	Global Medical Institutes	Miami	Florida
United States	IMIC, Inc.	Miami	Florida
United States	Office of Emilio Mantero-Atienza, MD	Miami	Florida
United States	P&S Research, LLC	Miami	Florida
United States	Quantix Research	Miami	Florida
United States	South Florida Research Center Inc.	Miami Springs	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Intercoastal Medical Group	Sarasota	Florida
United States	Accel Clinical Research	Seminole	Florida
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Medical Advancement Center of Arizona	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Neuropsychiatric Inventory-Clinician Rating (NPI-C) Agitation and Aggression (A plus A) Scores	The NPI-12 is a measure of psychobehavioral disturbances assessing the frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain is rated on a 4-point scale (from 1=rarely to 4=very often) and severity on a 3-point scale (from 1=mild to 3=severe), with the score for each domain being the product of the frequency and severity scores, such that each domain is scored from 1 to 12. The NPI-12 total score is the sum of the 12 domain scores, ranging from 0 (best) to 144 (worst). NPI-C is an instrument developed on the basis of original NPI that gives a score based on product of frequency and severity ratings of 12 symptom domains that can then be summed to a total score. Five domains will be measured in the study with NPI-C: Delusions, Hallucinations, Agitation, Aggression, Dysphoria, and will include both caregiver and participant interviews. Higher scores on the NPI-C are associated with a greater clinical severity of symptoms.	Baseline up to Day 43
Secondary	Change From Baseline on the Total Cohen-mansfield Agitation Inventory-Community Version (CMAI-C) Score	The CMAI-C is a 37-item scale that measures the ability of a drug to reduce overall frequency of agitation symptoms, including aggressive behaviors. Individual items are rated on a scale of 1 (never) to 7 (several times per hour) in which a score of 7 represents the most frequent for each item assessed. The total score is a sum of all categories that ranges form 37-259, where higher score indicates greater severity.	Baseline up to Day 43
Secondary	Change from Baseline in Sleep Disorder Inventory (SDI) Total Score	SDI is based on a caregiver interview and an expanded version of one item of the NPI-12. It describes the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI total score ranges from 0-12 where higher score indicates greater severity.	Baseline up to Day 43
Secondary	Plasma Concentrations of Seltorexant and its Metabolite	Plasma samples will be analyzed to measure concentrations of seltorexant and its metabolite using a validated, specific, and sensitive Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC- MS/MS) method.	Day 15 and Day 43