New dissolving film shows promise for agitation in dementia
NCT ID NCT04251910
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a sublingual film containing dexmedetomidine (BXCL501) to quickly calm agitation in 100 older adults with dementia. Participants received either the drug or a placebo, and researchers measured changes in agitation scores and side effects. The goal was to find a safe, easy-to-use treatment for acute agitation episodes.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Dexmedetomidine (given as a sublingual film)
What this could lead to
If it works, this could provide a fast-acting, non-injectable option to calm agitation in people with dementia, improving their comfort and care.
What could go wrong
This is an early-phase trial with only 100 participants, so results may not apply to everyone. The drug may cause side effects or not work better than placebo.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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BioXcel Clinical Research Site
Homestead, Florida, 33032, United States
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BioXcel Clinical Research Site
Miami Lakes, Florida, 33016, United States
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BioXcel Clinical Research Site
Springfield, Massachusetts, 01103, United States
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BioXcel Clinical Research Site
Caro, Michigan, 48723, United States
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BioXcel Clinical Research Site
Toms River, New Jersey, 08755, United States