Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Teikoku Pharma USA, Inc.
Study ID
NCT06052254
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Agitation

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 12 cm2 - 2 Active DMTS Patches — DRUG
    2 Active DMTS patches applied to the upper back followed 14 days later by another application of 2 Active DMTS patches. Each application will be worn for 4 days (96 hours)
  • 6 cm2 - 1 Active and 1 Placebo DMTS Patches — DRUG
    1 Active and 1 Placebo DMTS patches applied to the upper back followed 14 days later by another application of 1 Active and 1 Placebo DMTS patches. Each application will be worn for 4 days (96 hours)
  • Placebo - 2 Placebo DMTS Patches — DRUG
    2 Placebo DMTS patches applied to the upper back followed 14 days later by another application of 2 Placebo DMTS patches. Each application will be worn for 4 days (96 hours)

Study Details

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.

Key Dates

Start date
Sep 16, 2025
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 12 cm2 - 2 Active DMTS Patches
    2 Active DMTS patches will be applied to the upper back and worn for 4 days (96 hours) followed 14 days later with the same treatment for an additional 4-day treatment for subjects that are eligible for a second dosing.
  • Active Comparator: 6 cm2 - 1 Active and 1 Placebo DMTS Patches
    1 Active and 1 Placebo DMTS patches will be applied to the upper back and worn for 4 days (96 hours) followed 14 days later with the same treatment for an additional 4-day treatment period for subjects that are eligible for a second dosing.
  • Placebo Comparator: Placebo - 2 Placebo DMTS Patches
    2 Placebo DMTS patches will be applied to the upper back and worn for 4 days (96 hours) followed 14 days later with the same treatment for an additional 4-day treatment period for subjects that are eligible for a second dosing.

Primary Outcome Measure

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). [ Time Frame: Baseline (Day -4 to Day -1) to 96 hours after first application (Day 1 to Day 4) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Professional Health Care of Pinellas, LLCSt. PetersburgFlorida33713
Melissa Suarez
[email protected]
727-820-1033
Fadi Saba, MD (PRINCIPAL_INVESTIGATOR)
Elixia MA, LLCSpringfieldMassachusetts01103-
VitalixWorcesterMassachusetts01608
Matthew Collins
[email protected]
413-363-5206
James Carroll, MD (PRINCIPAL_INVESTIGATOR)
BioBehavioral HealthToms RiverNew Jersey08755
Madison Filtcraft
[email protected]
732-244-2299
Ashok Patel, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Professional Health Care of Pinellas, LLC· St. Petersburg, FLElixia MA, LLC· Springfield, MAVitalix· Worcester, MABioBehavioral Health· Toms River, NJ

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