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NCT05307692CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 27 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
88 (actual)
First submitted
25 Mar 2022
Start date
19 May 2022
Primary completion date
10 Nov 2023
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05307692

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 88
  • From 19 May 2022 to the primary completion date, 10 Nov 2023
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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)

Who the study is looking for

  • 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)

Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sonar Clinical Research
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Atlanta Center for Medical Research
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AtlantaUnited StatesUnknown status
NeuroTrials Research Inc
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Memory Clinic, Inc.
Coordinator of this site? Confirm its status
BenningtonUnited StatesUnknown status
Boston Clinical Trials
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BostonUnited StatesUnknown status
Gill Neuroscience
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CypressUnited StatesUnknown status
Luminous Clinical Research
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HomesteadUnited StatesUnknown status
Sunwise Clinical Research
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LafayetteUnited StatesUnknown status
Allied Biomedical Research Institute (ABRI), Inc
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MiamiUnited StatesUnknown status
Florida International Research Center (FIRC)
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MiamiUnited StatesUnknown status
Office of Emilio Mantero-Atienza, MD
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MiamiUnited StatesUnknown status
Global Medical Institutes
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MiamiUnited StatesUnknown status
Entrust Clinical Research
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MiamiUnited StatesUnknown status
Quantix Research
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MiamiUnited StatesUnknown status
IMIC, Inc.
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MiamiUnited StatesUnknown status
Biovision Medical
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MiamiUnited StatesUnknown status
P&S Research, LLC
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MiamiUnited StatesUnknown status
South Florida Research Center Inc.
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Miami SpringsUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Ochsner Medical Center
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New OrleansUnited StatesUnknown status
Wasatch Clinical Research
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Salt Lake CityUnited StatesUnknown status
Intercoastal Medical Group
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SarasotaUnited StatesUnknown status
Accel Clinical Research
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SeminoleUnited StatesUnknown status
Richmond Behavioral Associates
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Staten IslandUnited StatesUnknown status
Medical Advancement Center of Arizona
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TempeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.