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NCT06052254 · ClinicalTrials.gov registry record · Phase 2
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
A Phase 2 study of Agitation, sponsored by Teikoku Pharma USA.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 3
- Study locations
NCT06052254: Recruiting Phase 2 study of Agitation, sponsored by Teikoku Pharma USA.
NCT06052254 is a Phase 2 study of Agitation that is actively recruiting participants, run by Teikoku Pharma USA. The registered enrollment target is 150 participants, below the 192-participant average among 8 other Agitation trials with a reported enrollment target (22% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06052254, a Phase 2 study of Agitation, is actively recruiting participants, sponsored by Teikoku Pharma USA.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.
Primary Outcome
The ABS \[5\] is a 14-item scale developed to allow objective assessment of agitated behavior, particularly serial assessments for the evaluation of interventions to reduce agitation. The ABS Total Score ranges from 14 to 56. A total score of 21 or less is considered Normal; 22 to 28 is considered Mild; 29 to 35 Moderate; and 36 or more Severe Agitation.
Conditions Studied
Interventions
- DRUG 12 cm2 - 2 Active DMTS Patches
- DRUG 6 cm2 - 1 Active and 1 Placebo DMTS Patches
- DRUG Placebo - 2 Placebo DMTS Patches
Study Locations (3)
Massachusetts
- Elixia MA, LLC - Springfield
- Vitalix - Worcester
New Jersey
- BioBehavioral Health - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-09-16 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What NCT06052254 shows while recruiting
NCT06052254 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 8 other Agitation trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Agitation appearing as the primary indexed condition, and to 3 interventions - of which 12 cm2 - 2 Active DMTS Patches is the first listed.
NCT06052254 reports a single indexed study location in Massachusetts, New Jersey.
Frequently Asked Questions
What is clinical trial NCT06052254 about?
NCT06052254 is a clinical study titled "Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type". The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.
What is the current status of trial NCT06052254?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-09-16. Estimated completion is 2027-01.
What conditions does trial NCT06052254 study?
This clinical trial studies the following conditions: Agitation.
What interventions are being tested in trial NCT06052254?
The interventions under investigation include: 12 cm2 - 2 Active DMTS Patches (DRUG), 6 cm2 - 1 Active and 1 Placebo DMTS Patches (DRUG), Placebo - 2 Placebo DMTS Patches (DRUG).
Who is sponsoring clinical trial NCT06052254?
This trial is sponsored by Teikoku Pharma USA, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06052254 being conducted?
This trial has 3 study locations across Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Agitation
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 NCT06052254's enrollment target sits among peer trials
150 4th of 8 higher than 5 of 8 other Agitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Agitation 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
-
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
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-
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COMPLETED
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