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

Recruiting at 32 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must not be taking: Prohibited medications

Disqualifiers: Non-Alzheimer's dementia, Acute illness, Delirium, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

88 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants must be stable on their current medications and cannot take prohibited ones.

What makes the drug Seltorexant unique compared to other treatments?

Seltorexant, also known as JNJ-42847922 or MIN-202, is unique because it is being studied for its effects compared to a placebo, which helps determine its specific impact on the condition being treated. This approach is different from comparing it to other active treatments, which is common in many clinical trials. ^{1 2 3 4 5}

Research Team

Janssen Research and Development, LLC Clinical Trial

Principal Investigator

Janssen Research and Development LLC

Eligibility Criteria

Inclusion Criteria

Female participants must be postmenopausal before study entry (amenorrhea for at least 12 months)

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 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

Exclusion Criteria

Participant has a clinically significant acute illness within 7 days prior to study intervention administration

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)

Participants who are not stable on concomitant medications or take prohibited medications

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either seltorexant or placebo once daily from Day 1 to Day 42

6 weeks

Daily dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Placebo
• Seltorexant

Participant Groups

Group I: Seltorexant Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

References

1. England pubmed.ncbi.nlm.nih.gov

Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

A multiple-dose double-blind randomized study to evaluate the safety, pharmacokinetics, pharmacodynamics and analgesic efficacy of the TRPV1 antagonist JNJ-39439335 (mavatrep). [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

Controlled clinical trial on a new nonsteroidal anti-inflammatory drug (NSAID) therapy for arthropathic patients. [2013]

4. England pubmed.ncbi.nlm.nih.gov

The sensitivity to change for lower disease activity is greater than for higher disease activity in rheumatoid arthritis trials. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Piroxicam immediate release formulations: A fasting randomized open-label crossover bioequivalence study in healthy volunteers. [2018]