New dissolving film shows promise for agitation in dementia

NCT ID NCT04251910

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

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

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.

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.

dementia Psychomotor Agitation

As listed by the trial registrant

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

AGITATION,PSYCHOMOTOR DEMENTIA

Contacts and locations

Locations

BioXcel Clinical Research Site

Homestead, Florida, 33032, United States
BioXcel Clinical Research Site

Miami Lakes, Florida, 33016, United States
BioXcel Clinical Research Site

Springfield, Massachusetts, 01103, United States
BioXcel Clinical Research Site

Caro, Michigan, 48723, United States
BioXcel Clinical Research Site

Toms River, New Jersey, 08755, United States

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