Dementia agitation drug trial halted after just 5 patients

NCT ID NCT05276830

Terminated Symptom relief Sponsor: BioXcel Therapeutics Inc Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study tested a fast-dissolving film (BXCL501) placed under the tongue to quickly reduce severe agitation in older adults with dementia. The trial aimed to enroll many participants but was stopped early after only 5 people joined. Because it ended so soon, we cannot draw reliable conclusions about whether the drug works or is safe.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Dexmedetomidine (BXCL501) sublingual film
What this could lead to: If it worked, this could offer a fast-acting option to calm agitation in people with dementia, reducing distress for patients and caregivers.
What could go wrong: The trial was terminated early with only 5 participants, so results are very limited. It is unclear if the drug is safe or effective for this use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia frontotemporal dementia Psychomotor Agitation vascular dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AGITATION DEMENTIA

Contacts and locations

Locations

BioXcel Clinical Research Site

Toms River, New Jersey, 08755, United States
Bioxcel Clinical Research Site

North Miami, Florida, 33161, United States
Bioxcel Clinical Research Site

Springfield, Massachusetts, 01103, United States

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