Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05307692 · ClinicalTrials.gov registry record · Phase 2
A Study of Seltorexant in Participants With Probable Alzheimer's Disease
A Phase 2 study of Alzheimer Disease, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 20
- Study locations
NCT05307692: Completed Phase 2 study of Alzheimer Disease, sponsored by Janssen Research & Development.
NCT05307692 is a Phase 2 study of Alzheimer Disease that has completed, run by Janssen Research & Development. The registered enrollment target is 88 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05307692, a Phase 2 study of Alzheimer Disease, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The NPI-12, measure of psychobehavioral disturbances assessed frequency and severity of disturbances in 12 domains, based on a caregiver interview. Frequency for each domain was 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 product of frequency and severity scores, such that each domain was scored from 1 to 12. The NPI-12 total score was the sum of 12 domain scores, ranging from 0 (best) to
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Seltorexant
Study Locations (20)
Florida
- Luminous Clinical Research - Homestead
- Global Medical Institutes - Miami
- Office of Emilio Mantero-Atienza, MD - Miami
- Allied Biomedical Research Institute (ABRI), Inc - Miami
- Quantix Research - Miami
- Entrust Clinical Research - Miami
- Florida International Research Center (FIRC) - Miami
- P&S Research, LLC - Miami
- IMIC Inc - Miami
- Biovision Medical - Miami
- South Florida Research Center Inc. - Miami Springs
- Intercoastal Medical Group - Sarasota
- Accel Clinical Research - Seminole
Georgia
- Sonar Clinical Research - Atlanta
- NeuroTrials Research Inc - Atlanta
- Atlanta Center for Medical Research - Atlanta
Arizona
- Medical Advancement Center of Arizona - Tempe
California
- Sunwise Clinical Research - Lafayette
Louisiana
- Ochsner Medical Center - New Orleans
Massachusetts
- Boston Clinical Trials - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2022-05-19 |
| Est. Completion | 2023-11-10 |
| Phase | Phase 2 |
What the finished NCT05307692 record still lists
NCT05307692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05307692 names 20 study sites across 6 states, led by Florida, Georgia, Arizona.
Frequently Asked Questions
What is clinical trial NCT05307692 about?
NCT05307692 is a clinical study titled "A Study of Seltorexant in Participants With Probable Alzheimer's Disease". 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...
What is the current status of trial NCT05307692?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2022-05-19. Estimated completion is 2023-11-10.
What conditions does trial NCT05307692 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT05307692?
The interventions under investigation include: Placebo (DRUG), Seltorexant (DRUG).
Who is sponsoring clinical trial NCT05307692?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05307692 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05307692's enrollment target sits among peer trials
88 163rd of 306 higher than 144 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Systemic and Central Inflammation in AD
RECRUITING · Phase 2
-
Study of LHP588 in Subjects With P. Gingivalis-Positive Alzheimer's Disease
RECRUITING · Phase 2
-
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
RECRUITING · Phase 2
-
Sleep Trial to Prevent Alzheimer's Disease
RECRUITING · Phase 2
-
A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
RECRUITING · Phase 2
-
Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03843463 · 88 participants · Phase 2
Escitalopram and Language Intervention for Subacute Aphasia
- NCT04066348 · 88 participants · Phase 2
TNF-α Treatment of Blast-Induced Tinnitus
- NCT04331704 · 88 participants · Phase 4
ANCHORS Alcohol & Sexual Health Study: UH3 Project
- NCT04536103 · 88 participants
Multi-Vendor Multi-Site Novel Accelerated MRI Relaxometry
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI