Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug calms dementia agitation in phase 3 trial

NCT ID NCT05271552

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tested a medicine called BXCL501 for calming sudden episodes of agitation in people with dementia. It involved 151 participants who took the medicine only when needed over 12 weeks. The goal was to see if it safely reduces severe restlessness, tension, or aggression.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

151 people

The number who actually took part.

Started

Apr 2022

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. All subjects must have a diagnosis of probable AD based on NIA-AA criteria (2018) 2. Episodes of psychomotor agitation (e.g., kick, bite, flailing) 3. Subjects exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior 4. A score of 15 to 23 on the Mini-Mental State Exam (MMSE) 5. Subjects who read, understand, and provide written informed consent, or who have a LAR to provide consent on their behalf 6. Subjects who are deemed to be medically appropriate for study participation by the principal investigator 7. Participants who agree to use a medically acceptable and effective birth control method Exclusion Criteria: 1. Subjects with dementia or other memory impairment not due to probable AD. 2. Clinical diagnosis of probable AD should not be applied when there is evidence of a cerebrovascular incident temporally related to the worsening of cognitive function. 3. Subjects with agitation caused by acute intoxication. 4. Subjects with significant risk of suicide or homicide per the investigator's assessment. 5. Subjects who are medically unstable or in recovery. Note: Subjects with a remote (\>5 years) history of stroke may be included, regardless of size/location. 6. History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia. 7. Subjects who had a total score of \>13 (ie, high fall risk) on the John Hopkins Fall Risk Assessment Tool. 8. Subjects with laboratory or ECG abnormalities. 9. Subjects who have received an investigational drug within 30 days prior to Screening. 10. Subjects who are currently suffering from substance abuse. Patients with a potential cause for delirium (relatively recent onset agitation and dementia)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Agitation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia Psychomotor Agitation

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

    Phoenix, Arizona, 85016, United States

  • BioXcel Clinical Research Site

    Long Beach, California, 90806, United States

  • BioXcel Clinical Research Site

    Daytona Beach, Florida, 32117, United States

  • BioXcel Clinical Research Site

    Lady Lake, Florida, 32159, United States

  • BioXcel Clinical Research Site

    Maitland, Florida, 32751, United States

  • BioXcel Clinical Research Site

    Miami Lakes, Florida, 33016, United States

  • BioXcel Clinical Research Site

    North Miami, Florida, 33161, United States

  • BioXcel Clinical Research Site

    Marrero, Louisiana, 70072, United States

  • BioXcel Clinical Research Site

    Springfield, Massachusetts, 01103, United States

  • BioXcel Clinical Research Site

    Berlin, New Jersey, 08009, United States

  • BioXcel Clinical Research Site

    Toms River, New Jersey, 08755, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.