Dexmedetomidine Patches for Agitation in Dementia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, Dexmedetomidine Transdermal Systems (DMTS), to determine if it can reduce the frequency and severity of agitation in individuals with Alzheimer's-related dementia. Participants will wear patches on their upper back for short periods, and researchers will compare the effects to placebo patches. Suitable candidates have a diagnosis of Alzheimer's dementia and frequently experience agitation that impacts daily activities and social interactions. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications if they have been stable for at least 30 days before screening. However, certain natural health products and corticosteroids should be avoided close to the study start.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that dexmedetomidine has been safely used to manage agitation in people with delirium. Earlier studies found the treatment beneficial without major safety concerns.
This trial tests a dexmedetomidine patch (DMTS) for people with dementia. As a Phase 2 trial, earlier tests have generally shown the treatment to be safe for humans. This trial aims to learn more about how well people handle the patch and any possible side effects.
For those considering joining this trial, it's important to know that dexmedetomidine is already used in other medical situations, providing some confidence about its safety. However, individual experiences may vary with any treatment.12345Why do researchers think this study treatment might be promising for dementia?
Researchers are excited about dexmedetomidine patches for agitation in dementia because they offer a new way to manage symptoms through a transdermal system. Unlike traditional medications that are often taken orally, these patches deliver the medication directly through the skin, which can be more convenient and potentially reduce side effects associated with oral administration. Dexmedetomidine itself is known for its sedative properties and works by targeting specific receptors in the brain, which might provide a more targeted approach to calming agitation. This method could represent a significant improvement over current options like antipsychotics or benzodiazepines, which can have more systemic effects and side effects.
What evidence suggests that Dexmedetomidine Transdermal Systems could be effective for agitation in dementia?
Research shows that dexmedetomidine, primarily used for relaxation, has effectively treated restlessness caused by delirium. This trial will test various formulations of dexmedetomidine transdermal systems (DMTS) patches to determine their effectiveness in calming agitation in Alzheimer's patients. The drug soothes specific brain areas, reducing restlessness. While studies on its use for Alzheimer's-related agitation are ongoing, its success in similar situations offers hope for effectiveness.12356
Who Is on the Research Team?
James Song, MS
Principal Investigator
Teikoku Pharma USA, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals aged 60 or older with Alzheimer's-related dementia, experiencing agitation that affects their daily life. They must live in a care facility, not have had recent medication changes, and use reliable contraception if of childbearing potential. Those unable to consent, outside the BMI range of 20-38 kg/m2, or pregnant are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DMTS or placebo patches applied to the upper back for 4 days, followed by a 14-day washout period, and then a second 4-day treatment for eligible subjects
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexmedetomidine Transdermal Systems (DMTS)
Trial Overview
The study tests the effectiveness of Dexmedetomidine Transdermal Systems (DMTS) on reducing agitation in Alzheimer's patients. Participants will receive either two active DMTS patches, one active and one placebo patch, or two placebo patches to compare outcomes.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Teikoku Pharma USA, Inc.
Lead Sponsor
Citations
NCT06052254 | Dexmedetomidine Transdermal Systems ...
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, ...
Dexmedetomidine for agitation in dementia: Current data and ...
Dexmedetomidine has been used for agitation related to delirium and showed significant benefit in prior studies.
Dexmedetomidine for agitation in dementia: Current data ...
Dexmedetomidine has been used for agitation related to delirium and showed significant benefit in prior studies.
4.
app.trialscreen.org
app.trialscreen.org/trials/phase-2-dexmedetomidine-transdermal-systems-dmts-treatment-agitation-associated-trial-nct06052254Dexmedetomidine Transdermal Systems (DMTS ...
A Phase 2 interventional study of dexmedetomidine transdermal systems in agitation associated with Alzheimer's dementia.
Dexmedetomidine Transdermal Systems (DMTS) Treatment ...
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, ...
Dexmedetomidine Transdermal Systems (DMTS) ...
The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the ...
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