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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05307692
Collaborator
(none)
86
Enrollment
33
Locations
2
Arms
11
Anticipated Duration (Months)
2.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 19, 2022
Anticipated Primary Completion Date :
Apr 19, 2023
Anticipated Study Completion Date :
Apr 19, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Seltorexant

Participants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.

Drug: Seltorexant
Seltorexant 20 mg will be administered orally as a tablet.
Other Names:
  • JNJ-42847922

    		•
    Placebo Comparator: Placebo

    Participants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.

    Drug: Placebo
    Matching placebo will be administered orally as a tablet.

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Neuropsychiatric Inventory-Clinician Rating (NPI-C) Agitation and Aggression (A plus A) Scores [Baseline up to Day 43]

      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.

    Secondary Outcome Measures

    1. Change From Baseline on the Total Cohen-mansfield Agitation Inventory-Community Version (CMAI-C) Score [Baseline up to Day 43]

      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.

    2. Change from Baseline in Sleep Disorder Inventory (SDI) Total Score [Baseline up to Day 43]

      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.

    3. Plasma Concentrations of Seltorexant and its Metabolite [Day 15 and Day 43]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 (>=) 2; 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Onyx Clinical Research Peoria Arizona United States 85381
    2 Advanced Research Center Inc Anaheim California United States 92805
    3 Luminous Clinical Research Homestead Florida United States 33030
    4 South Florida Research Center Inc. Miami Springs Florida United States 33166
    5 Global Medical Institutes Miami Florida United States 33125
    6 Office of Emilio Mantero-Atienza, MD Miami Florida United States 33135
    7 Allied Biomedical Research Institute (ABRI), Inc Miami Florida United States 33155-4630
    8 Entrust Clinical Research Miami Florida United States 33156
    9 Florida International Research Center (FIRC) Miami Florida United States 33173
    10 P&S Research, LLC Miami Florida United States 33175
    11 Biovision Medical Miami Florida United States 33184
    12 Neurology Associates of Ormond Beach Ormond Beach Florida United States 32174
    13 IMIC, Inc. Palmetto Bay Florida United States 33157
    14 Intercoastal Medical Group Sarasota Florida United States 34239
    15 Meridien Research Tampa Florida United States 33634
    16 Sonar Clinical Research Atlanta Georgia United States 30315
    17 NeuroTrials Research Inc Atlanta Georgia United States 30328
    18 Atlanta Center for Medical Research Atlanta Georgia United States 30331
    19 University of Kentucky Lexington Kentucky United States 40506
    20 Ochsner Medical Center New Orleans Louisiana United States 70121
    21 Boston Clinical Trials Boston Massachusetts United States 02131
    22 Lahey Hospital & Medical Center Burlington Massachusetts United States 01805
    23 Onyx Clinical Research Flint Michigan United States 48532
    24 Mid Hudson Medical Research New Windsor New York United States 12572
    25 Richmond Behavioral Associates Staten Island New York United States 10312
    26 Stony Brook University Medical Center Stony Brook New York United States 11794
    27 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    28 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    29 Gill Neuroscience Cypress Texas United States 77429
    30 Wasatch Clinical Research Salt Lake City Utah United States 84107
    31 Memory Clinic Inc Bennington Vermont United States 05201
    32 Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3' Kharkiv Ukraine 61068
    33 Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa) Kyiv Ukraine 02192

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research and Development, LLC Clinical Trial, Janssen Research and Development LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05307692
    Other Study ID Numbers:
    • CR109177
    • 42847922ALZ2001
    First Posted:
    Apr 1, 2022
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Aug 18, 2022