AgitationPhase 3NCT05665088

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

A Phase 3 study testing BXCL501 in people with Agitation and Dementia, run by BioXcel Therapeutics Inc at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 168 doses within a 12-week treatment period. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Agitation, Dementia
What is being tested?: BXCL501
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 7 sitesUnited States
Study dates: 5 Dec 2022to 11 Sep 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

All participants must have a diagnosis of probable Alzheimer's disease (AD) based on National Institute on Aging and Alzheimer's Association (NIA-AA) criteria (2018). If participant biomarker data are unavailable, per the 2018 NIA-AA diagnostic criteria, the clinical diagnosis of probable AD will be based on the 2011 NIA-AA criteria
Episodes of psychomotor agitation (e.g., kick, bite, flailing)
Participants exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the participant's usual behavior
A score of 0 to 20 on the Mini-Mental State Exam (MMSE) and require moderate to full assistance with activities of daily living
Participants who read, understand, and provide written informed consent, or who have a legally authorized representative (LAR) to provide consent on their behalf
Participants who are deemed to be medically appropriate for study participation by the principal investigator
Participants who agree to use a medically acceptable and effective birth control method

Who cannot join

Participants with dementia or other memory impairment not due to probable AD.
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.
Participants with agitation caused by acute intoxication.
Participants with significant risk of suicide or homicide per the investigator's assessment.
Participants who are medically unstable or in recovery. Note: Participants with a remote (>5 years) history of stroke may be included, regardless of size/location.
History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia.

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Participants with laboratory or electrocardiogram (ECG) abnormalities.
Participants who have received an investigational drug within 30 days prior to Screening.
Participants who are currently suffering from substance abuse.
Participants with a potential cause for delirium (relatively recent onset agitation and dementia)

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

BioXcel Clinical Research Site
Daytona Beach, Florida, 32117
BioXcel Clinical Research Site
Los Alamitos, California, 90720
BioXcel Clinical Research Site
Maitland, Florida, 32751
BioXcel Clinical Research Site
Marrero, Louisiana, 70072
BioXcel Clinical Research Site
Springfield, Massachusetts, 01103
BioXcel Clinical Research Site
The Villages, Florida, 32162
BioXcel Clinical Research Site
Toms River, New Jersey, 08755

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects With Agitation Associated With Dementia Who Require at Least Moderate To Full Assistance With Activities of Daily Living

Read the detailed description

A randomized, double-blind, placebo-controlled, parallel group, 3-arm study assessing efficacy, safety, and tolerability of two doses of BXCL501 in male and female participants (65 years and older) with acute psychomotor agitation associated with dementia.

Approximately 150 participants will participate in this study. Participants will receive a single film consisting of BXCL501 40 micrograms (µg) dose or BXCL501 60 µg dose or placebo. Participants must reside in a care facility where all study-related procedures and study drug dosing will be performed.

Conditions: Agitation, Dementia
Being tested: BXCL501, Matching Placebo
Medical subject headings: Psychomotor Agitation, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BXCL501Drug
Also called Dexmedetomidine
Solid-dose film administered sublingually or buccally
Matching PlaceboDrug
Matching solid-dose film administered sublingually or buccally

Study groups in NCT05665088
Study group	Role	What they receive
BXCL501: 40 μg	Experimental	Participants will receive 40 μg of BXCL501 sublingually or buccally, with up to 2 doses permitted per calendar day over the 12-week treatment period. Receives: Drug: BXCL501
BXCL501: 60 μg	Experimental	Participants will receive 60 μg of BXCL501 sublingually or buccally, with up to 2 doses permitted per calendar day over the 12-week treatment period. Receives: Drug: BXCL501
Placebo	Placebo comparator	Participants will receive placebo-matched to BXCL501 with up to 2 doses permitted per calendar day over the 12-week treatment period. Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Pre-dose in PEC Total Score at 30 Minutes Post-dose for the First Treated Episode of Agitation
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Measured: Pre-dose, 30 minutes post-dose
Change From Pre-dose in PEC Total Score at 1 Hour Post-dose for the First Treated Episode of Agitation
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Measured: Pre-dose, 1 hour post-dose
Change From Pre-dose in PEC Total Score at 2 Hours Post-dose for the First Treated Episode of Agitation
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Measured: Pre-dose, 2 hours post-dose
Change From Pre-dose in PEC Total Score at 4 Hours Post-dose for the First Treated Episode of Agitation
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Measured: Pre-dose, 4 hours post-dose
Change From Pre-dose in PEC Total Score at 8 Hours Post-dose for the First Treated Episode of Agitation
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Measured: Pre-dose, 8 hours post-dose
Change From Pre-dose in PEC Total Score at 12 Hours Post-dose for the First Treated Episode of Agitation
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Measured: Pre-dose, 12 hours post-dose
Change From Pre-dose in PEC Total Score at 24 Hours Post-dose for the First Treated Episode of Agitation
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Measured: Pre-dose, 24 hours post-dose

Secondary outcomes (5)

Change From Pre-dose in Pittsburgh Agitation Scale (PAS) Total Score at 2 Hours Post-dose for the First Episode of Agitation
The PAS is an instrument based on direct observations of the participant that is developed to monitor the severity of agitation associated with dementia. The PAS is the sum of 4 behavior groups observed (aberrant vocalization, motor agitation, aggressiveness, resisting care, each behavior group ranging from 0 [not present] to 4 [maximally present]), and thus total score ranges from 0 (absence of agitation) to 16 (extremely severe). Lower score indicated better outcome.
Measured: Pre-dose, 2 hours post-dose
Change From Pre-dose in Clinical Global Impression of Severity (CGI-S) Score at 2 Hours Post-dose for the First Episode of Agitation
The CGI-S was used to rate the severity of agitation. The score ranges from 0 to 4 that comprises of, 0=not assessed; 1=normal, not at all symptomatic; 2=mildly symptomatic-low level of symptoms-little interference in social functioning; 3=moderately symptomatic-some prominent symptoms-some interference in functioning; 4=severely symptomatic- very marked symptoms make it difficult for participants to engage with others. Higher scores indicate greater severity of agitation.
Measured: Pre-dose, 2 hours post-dose
Clinical Global Impression of Improvement (CGI-I) Score at 30 Minutes, 1 Hour, and 2 Hours Post-dose for the First Treated Episodes of Agitation
The CGI-I is a global measure of improvement or change from baseline in participant's condition. The CGI-I score ranges from 0 to 7 that comprises of 0 = not assessed (missing), 1= very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, and 7= very much worse. Higher scores indicate worse condition.
Measured: 30 minutes, 1 hour, and 2 hours post-dose
Change From Pre-dose in Agitation-Calmness Evaluation Scale (ACES) Scores at 1, 2, 4, and 8 Hours Post-dose for the First Episode of Agitation.
The ACES is a single-item clinician-rated measure of agitation and sedation. Scores range from 1 to 9, where 1= marked agitation, 2= moderate agitation, 3= mild agitation, 4= normal behavior, 5= mild calmness, 6= moderate calmness, 7= marked calmness, 8= deep sleep, and 9= unarousable. Higher scores indicate greater levels of calmness and sedation.
Measured: Pre-dose, 1, 2 , 4 and 8 hours post-dose
Number of Treated Episodes of Agitation After the First Treated Episode
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 202211 Sep 2023

First posted27 Dec 2022
Study start5 Dec 2022
Primary completion11 Sep 2023
Study completion11 Sep 2023

Why it stopped: Study was terminated for business reasons; not due to safety or efficacy concerns

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AgitationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05665088
Sponsor's protocol ID: BXCL501-304
Status last verified: Sep 2026
First submitted: 16 Dec 2022
Last updated: 1 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 2/3
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Agitation Associated With Alzheimer's Disease Dementia
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness

All Agitation trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects With Agitation Associated With Dementia Who Require at Least Moderate To Full Assistance With Activities of Daily Living
ClinicalTrials.gov ID: NCT05665088
Acronym / sponsor ID: BXCL501-304
Conditions: Agitation, Dementia
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated for business reasons; not due to safety or efficacy concerns
Enrolment: 13 participants (actual)
Lead sponsor: BioXcel Therapeutics IncIndustry (pharma, biotech, devices)
Collaborators: Cognitive Research Corporation
Study start: 5 Dec 2022 (actual)
Primary completion: 11 Sep 2023 (actual)
Study completion: 11 Sep 2023 (actual)
First posted: 27 Dec 2022 (actual)
Results: Posted 1 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
Model description: Randomized

Arm	Type	Receives
BXCL501: 40 μg	Experimental	Drug: BXCL501Participants will receive 40 μg of BXCL501 sublingually or buccally, with up to 2 doses permitted per calendar day over the 12-week treatment period.
BXCL501: 60 μg	Experimental	Drug: BXCL501Participants will receive 60 μg of BXCL501 sublingually or buccally, with up to 2 doses permitted per calendar day over the 12-week treatment period.
Placebo	Placebo comparator	Drug: Matching PlaceboParticipants will receive placebo-matched to BXCL501 with up to 2 doses permitted per calendar day over the 12-week treatment period.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (7 listed)

All participants must have a diagnosis of probable Alzheimer's disease (AD) based on National Institute on Aging and Alzheimer's Association (NIA-AA) criteria (2018). If participant biomarker data are unavailable, per the 2018 NIA-AA diagnostic criteria, the clinical diagnosis of probable AD will be based on the 2011 NIA-AA criteria
Episodes of psychomotor agitation (e.g., kick, bite, flailing)
Participants exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the participant's usual behavior
A score of 0 to 20 on the Mini-Mental State Exam (MMSE) and require moderate to full assistance with activities of daily living
Participants who read, understand, and provide written informed consent, or who have a legally authorized representative (LAR) to provide consent on their behalf

Key exclusion criteria (10 listed)

Participants with dementia or other memory impairment not due to probable AD.
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.
Participants with agitation caused by acute intoxication.
Participants with significant risk of suicide or homicide per the investigator's assessment.
Participants who are medically unstable or in recovery. Note: Participants with a remote (>5 years) history of stroke may be included, regardless of size/location.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BXCL501Also: DexmedetomidineSolid-dose film administered sublingually or buccally	Drug	BXCL501: 40 μg, BXCL501: 60 μg
Matching PlaceboMatching solid-dose film administered sublingually or buccally	Drug	Placebo

Primary outcome

Change From Pre-dose in PEC Total Score at 30 Minutes Post-dose for the First Treated Episode of Agitation
Time frame: Pre-dose, 30 minutes post-dose
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Change From Pre-dose in PEC Total Score at 1 Hour Post-dose for the First Treated Episode of Agitation
Time frame: Pre-dose, 1 hour post-dose
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Change From Pre-dose in PEC Total Score at 2 Hours Post-dose for the First Treated Episode of Agitation
Time frame: Pre-dose, 2 hours post-dose
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Change From Pre-dose in PEC Total Score at 4 Hours Post-dose for the First Treated Episode of Agitation
Time frame: Pre-dose, 4 hours post-dose
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Change From Pre-dose in PEC Total Score at 8 Hours Post-dose for the First Treated Episode of Agitation
Time frame: Pre-dose, 8 hours post-dose
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Change From Pre-dose in PEC Total Score at 12 Hours Post-dose for the First Treated Episode of Agitation
Time frame: Pre-dose, 12 hours post-dose
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.
Change From Pre-dose in PEC Total Score at 24 Hours Post-dose for the First Treated Episode of Agitation
Time frame: Pre-dose, 24 hours post-dose
The PEC includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score ranges from 5 (absence of agitation) to 35 (extremely severe). Lower score indicated better outcome.

5 secondary outcomes

Change From Pre-dose in Pittsburgh Agitation Scale (PAS) Total Score at 2 Hours Post-dose for the First Episode of Agitation
Time frame: Pre-dose, 2 hours post-dose
Change From Pre-dose in Clinical Global Impression of Severity (CGI-S) Score at 2 Hours Post-dose for the First Episode of Agitation
Time frame: Pre-dose, 2 hours post-dose
Clinical Global Impression of Improvement (CGI-I) Score at 30 Minutes, 1 Hour, and 2 Hours Post-dose for the First Treated Episodes of Agitation
Time frame: 30 minutes, 1 hour, and 2 hours post-dose
Change From Pre-dose in Agitation-Calmness Evaluation Scale (ACES) Scores at 1, 2, 4, and 8 Hours Post-dose for the First Episode of Agitation.
Time frame: Pre-dose, 1, 2 , 4 and 8 hours post-dose
Number of Treated Episodes of Agitation After the First Treated Episode
Time frame: Up to 12 weeks

Results and safety

Results posted to the registry on 1 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BXCL501: 40 μg	5	4
BXCL501: 60 μg	3	3
Placebo	5	5

Primary outcome: Change From Pre-dose in PEC Total Score at 30 Minutes Post-dose for the First Treated Episode of Agitation

Time frame: Pre-dose, 30 minutes post-dose. Mean (Standard Deviation). Unit: score on a scale

Measure	BXCL501: 40 μg n = 5	BXCL501: 60 μg n = 3	Placebo n = 5
Value	-4.2 (2.28)	-3.0 (0.00)	-6.8 (5.81)

Population analysed: Safety Population: All participants who received at least 1 dose of study drug, with participants classified according to the drug actually received.

Primary outcome: Change From Pre-dose in PEC Total Score at 1 Hour Post-dose for the First Treated Episode of Agitation

Time frame: Pre-dose, 1 hour post-dose. Mean (Standard Deviation). Unit: score on a scale

Measure	BXCL501: 40 μg n = 5	BXCL501: 60 μg n = 3	Placebo n = 5
Value	-6.4 (2.07)	-5.7 (1.53)	-6.0 (5.79)

Population analysed: Participants in the Safety Population were analyzed.

Primary outcome: Change From Pre-dose in PEC Total Score at 2 Hours Post-dose for the First Treated Episode of Agitation

Time frame: Pre-dose, 2 hours post-dose. Mean (Standard Deviation). Unit: score on a scale

Measure	BXCL501: 40 μg n = 5	BXCL501: 60 μg n = 3	Placebo n = 5
Value	-4.4 (5.13)	-3.3 (3.51)	-5.2 (8.56)

Population analysed: Participants in the Safety Population were analyzed.

Primary outcome: Change From Pre-dose in PEC Total Score at 4 Hours Post-dose for the First Treated Episode of Agitation

Time frame: Pre-dose, 4 hours post-dose. Mean (Standard Deviation). Unit: score on a scale

Measure	BXCL501: 40 μg n = 1	BXCL501: 60 μg n = 1	Placebo n = 3
Value	-12.0	-11.0	-15.3 (2.31)

Population analysed: Participants in the Safety Population with available data were analyzed.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug up to 30 days after the last dose (maximum duration:16 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BXCL501: 40 μg	0 of 5 (0%)	2 of 5 (40%)	0 of 5
BXCL501: 60 μg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Placebo	1 of 5 (20%)	4 of 5 (80%)	0 of 5

Limitations and caveats (from the sponsor): Study was terminated for business reasons; not due to safety or efficacy concerns.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Risinger, MD study chair

BioXcel Therapeutics

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BXCL501 in people with Agitation and Dementia, run by BioXcel Therapeutics Inc at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Pre-dose in PEC Total Score at 30 Minutes Post-dose for the First Treated Episode of Agitation (time frame: Pre-dose, 30 minutes post-dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05665088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.