Trial · NCT06052254
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
NCT06052254, Phase 2, Active not recruiting, Teikoku Pharma USA, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type. Trials, record NCT06052254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06052254
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
- NCT number
- NCT06052254
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Teikoku Pharma USA, Inc.
- Conditions
- Agitation
- Interventions
- 12 cm2 - 2 Active DMTS Patches, 6 cm2 - 1 Active and 1 Placebo DMTS Patches, Placebo - 2 Placebo DMTS Patches
- First posted
- 2023-09-25
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Agitated Behavior Scale (ABS) total score from baseline (Day -4 to Day -1 mean score) to the 96 hours of first application (Day 1 to Day 4). | Baseline (Day -4 to Day -1) to 96 hours after first application (Day 1 to Day 4) | 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. |
| Secondary | Change in Clinical Global Impression Scale - Severity (CGI-S) score at 96 hours post-application (Day 5) relative to Pre-randomization (Day 1) baseline. | Day1 (Pre-randomization), Day 5 | The CGI-S is a one item, 4-point (1-4) clinician-rated scale in which higher ratings indicate greater severity of agitation. |
| Secondary | Change in ABS total score from baseline (Day -4 to Day -1 mean score) to the 168 hours post first application (Day 1 to Day 7). | From Day -4 through Day 7 | 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. |
| Secondary | Change in CGI-S score at 168 hours post application (Day 8) relative to Day 1 Pre-randomization baseline. | Day1 (Pre-randomization), Day 8 | The CGI-S is a one item, 4-point (1-4) clinician-rated scale in which higher ratings indicate greater severity of agitation. |
| Secondary | Percentage of subjects meeting the criteria for Day 15 DMTS/placebo application. | Day 15 | Number of subjects that meet the criteria for Day 15 dosing. |
| Secondary | Change from Pre-randomization Day 1 baseline score (Day -7 to Day -1 lookback) to 168 hours post application score (Day 1 to Day 7 lookback) in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH). | Day -7, Day 7 | The NPI-NH assesses the severity and frequency of each neuropsychiatric symptom and the amount of caregiver/study partner distress engendered by each of the neuropsychiatric symptoms based on a series of scripted questions administered to a designated informant with a 7-day lookback period. The frequency scale uses a 4-point scale (1-4), and the severity uses a 3-point scale (1-3) with the higher score indicating more frequency or severity. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06052254
GET https://conductscience.org/api/trials/v1/NCT06052254/registered