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Seltorexant for Alzheimer's Disease
Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15 and day 43
Awards & highlights
Summary
This trial is testing seltorexant, a medication that may help reduce agitation and aggression in people with Alzheimer's Disease. The study focuses on those who have significant symptoms that are hard to manage. Seltorexant works by calming brain activity, which might help improve mood and behavior.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 15 and day 43
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15 and day 43
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Neuropsychiatric Inventory-Clinician Rating (NPI-C) Agitation and Aggression (A plus A) Scores
Secondary study objectives
Change From Baseline on the Total Cohen-mansfield Agitation Inventory-Community Version (CMAI-C) Score
Change from Baseline in Sleep Disorder Inventory (SDI) Total Score
Plasma Concentrations of Seltorexant and its Metabolite
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SeltorexantExperimental Treatment1 Intervention
Participants will receive single oral dose of seltorexant 20 milligrams (mg) tablet once daily from Day 1 to Day 42.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive single oral dose of matching placebo tablet once daily from Day 1 to Day 42.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seltorexant
2021
Completed Phase 3
~1090
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,589 Total Patients Enrolled
Janssen Research and Development, LLC Clinical TrialStudy DirectorJanssen Research and Development LLC
9 Previous Clinical Trials
447,994 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You experienced confusion or disorientation within the past month or during the screening process.Your body mass index (BMI) falls between 18 and 40 kilograms per square meter (kg/m^2).You have a history of aggressive behavior not related to dementia, or your agitation is caused by something other than dementia, such as pain.You have been diagnosed with a condition called "agitation" by a medical professional specializing in cognitive disorders and this diagnosis has lasted for at least 2 weeks before the start of the screening process.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Seltorexant
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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