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

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Seltorexant
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Onyx Clinical ResearchRecruiting
  • Medical Advancement Center of ArizonaRecruiting
  • Sunwise Clinical ResearchRecruiting
  • South Florida Research Center Inc.Recruiting
  • Global Medical InstitutesRecruiting
  • Office of Emilio Mantero-Atienza, MDRecruiting
  • Allied Biomedical Research Institute (ABRI), IncRecruiting
  • Quantix ResearchRecruiting
  • Entrust Clinical ResearchRecruiting
  • Florida International Research Center (FIRC)Recruiting
  • P&S Research, LLCRecruiting
  • IMIC, Inc.Recruiting
  • Biovision MedicalRecruiting
  • Intercoastal Medical GroupRecruiting
  • Accel Clinical ResearchRecruiting
  • Sonar Clinical ResearchRecruiting
  • NeuroTrials Research IncRecruiting
  • Atlanta Center for Medical ResearchRecruiting
  • Ochsner Medical CenterRecruiting
  • Boston Clinical TrialsRecruiting
  • Richmond Behavioral AssociatesRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Gill NeuroscienceRecruiting
  • Wasatch Clinical ResearchRecruiting
  • Memory Clinic IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Seltorexant

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 25, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05307692
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
October 16, 2023 (Anticipated)
Study Completion Date
October 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Seltorexant
Arm Type
Experimental
Arm Description
Participants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.
Intervention Type
Drug
Intervention Name(s)
Seltorexant
Other Intervention Name(s)
JNJ-42847922
Intervention Description
Seltorexant 20 mg will be administered orally as a tablet.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered orally as a tablet.
Primary Outcome Measure Information:
Title
Change from Baseline in Neuropsychiatric Inventory-Clinician Rating (NPI-C) Agitation and Aggression (A plus A) Scores
Description
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.
Time Frame
Baseline up to Day 43
Secondary Outcome Measure Information:
Title
Change From Baseline on the Total Cohen-mansfield Agitation Inventory-Community Version (CMAI-C) Score
Description
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.
Time Frame
Baseline up to Day 43
Title
Change from Baseline in Sleep Disorder Inventory (SDI) Total Score
Description
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.
Time Frame
Baseline up to Day 43
Title
Plasma Concentrations of Seltorexant and its Metabolite
Description
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.
Time Frame
Day 15 and Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research and Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research and Development LLC
Official's Role
Study Director
Facility Information:
Facility Name
Onyx Clinical Research
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Advancement Center of Arizona
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Individual Site Status
Recruiting
Facility Name
Sunwise Clinical Research
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Name
South Florida Research Center Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Medical Institutes
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Office of Emilio Mantero-Atienza, MD
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Name
Allied Biomedical Research Institute (ABRI), Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-4630
Country
United States
Individual Site Status
Recruiting
Facility Name
Quantix Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Entrust Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida International Research Center (FIRC)
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
P&S Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
IMIC, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Biovision Medical
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Individual Site Status
Recruiting
Facility Name
Intercoastal Medical Group
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Clinical Research
City
Seminole
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Individual Site Status
Recruiting
Facility Name
Sonar Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30315
Country
United States
Individual Site Status
Recruiting
Facility Name
NeuroTrials Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Gill Neuroscience
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Individual Site Status
Recruiting
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Memory Clinic Inc
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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