Seltorexant for Alzheimer's Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of seltorexant in reducing agitation and aggression in individuals with probable Alzheimer's Disease. Participants will receive either seltorexant or a placebo (a pill that resembles the medicine but contains no active ingredients) to compare outcomes. Individuals diagnosed with Alzheimer's who experience significant agitation or aggression affecting daily life may be suitable candidates for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that seltorexant is likely to be safe for humans?

Research has shown that seltorexant has been tested for safety in various conditions. One study on depression with insomnia found that seltorexant had fewer side effects than quetiapine XR, suggesting it might be easier for people to handle.

Another study examined seltorexant's safety for treating insomnia and found that people generally tolerated it well, experiencing only mild side effects like headaches and drowsiness, which are common with many medications.

In summary, research indicates that seltorexant is generally well-tolerated. Most participants experienced only mild side effects, supporting its safety for use in conditions like Alzheimer's disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's Disease?

Unlike the standard treatments for Alzheimer's, which mainly focus on managing symptoms through cholinesterase inhibitors or memantine, seltorexant offers a fresh approach by targeting the orexin system. This is a new mechanism of action that aims to improve sleep disturbances, which are common in Alzheimer's patients and can significantly affect their quality of life. Researchers are excited about seltorexant because it could provide a dual benefit: easing sleep issues and potentially improving overall cognitive function. This novel approach holds promise for enhancing patient care beyond what's currently available.

What evidence suggests that seltorexant might be an effective treatment for Alzheimer's-related agitation and aggression?

Research shows that seltorexant, which participants in this trial may receive, may help with sleep and mood issues. Studies have found that seltorexant helps people fall asleep faster than other sleep aids. It also works well with antidepressants to treat depression and has fewer side effects. Notably, seltorexant has been effective at different doses compared to a placebo. This trial will compare seltorexant to a placebo to assess its potential to manage agitation and aggression in Alzheimer's patients by improving sleep and mood, which often relate to these symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Janssen Research and Development, LLC Clinical Trial

Principal Investigator

Janssen Research and Development LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Seltorexant

How Is the Trial Designed?

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+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. jnj.com jnj.com/media-center/press-releases/johnson-johnsons-investigational-seltorexant-shows-numerically-higher-response-in-patients-with-depression-with-insomnia-symptoms-with-fewer-side-effects-compared-to-quetiapine-xr

Seltorexant, in combination with an oral antidepressant ... Seltorexant, in combination with an oral antidepressant, demonstrated a numerically greater response rate at week 26 with a more favorable ...

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2837250

Efficacy and Safety of Seltorexant in Insomnia Disorder On day 14, compared with zolpidem, seltorexant, 10 mg and 20 mg, showed greater improvements in subjective sleep onset latency and subjective ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40802194/

Efficacy and Safety of Seltorexant in Insomnia Disorder Conclusions and relevance: Among participants with insomnia in this study, seltorexant, 10 mg and 20 mg, improved sleep initiation and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06559306

Phase 3 Study of Adjunctive Treatment With Seltorexant in ... The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as ...

5. nature.com nature.com/articles/s41380-024-02846-5

Treatment effect and safety of seltorexant as monotherapy ... Based on the results from the MMRM model, a significant positive efficacy signal was detected for seltorexant across dose levels versus placebo ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6722075/

The selective orexin-2 antagonist seltorexant (JNJ-42847922 ... To investigate the safety and tolerability of seltorexant, vital signs, suicidal ideation and adverse events were monitored. At baseline the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05236868

NCT05236868 | A Study of JNJ-42847922 (Seltorexant) in ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

8. medchemexpress.com medchemexpress.com/seltorexant.html?srsltid=AfmBOopysW6eOtkV9IMZcvAOz03-bts-wIKGsi8maSY7aeOHg55dTUFG

Seltorexant (JNJ-42847922) | Orexin-2 Receptor Antagonist Seltorexant. Inquiry Online. Your information is safe with us. ... SAFETY DATA SHEET (SDS). English - EN (480 KB) Français - FR (480 KB) Deutsch ...