AgitationPhase 2NCT05276830
An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia
A Phase 2 study testing BXCL501 in people with Agitation and Dementia, run by BioXcel Therapeutics Inc at 3 sites in United States.
Trial summary
A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation associated with all forms of dementia (i.e., probably Alzheimer's Disease, vascular dementia… Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- BXCL501
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Feb 2022to 1 Apr 2022
- Phase
- Phase 2
- 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
- Individuals diagnosed with any form of dementia (i.e., probable Alzheimer's Disease; vascular dementia; mixed; frontotemporal dementia)
- Subjects who have met DSM-5 criteria for dementia (major neurocognitive disorder) who have instances of acute psychomotor agitation.
- History of psychomotor agitation (e.g., kick, bite, flailing) to the point that it impairs social activities, requires staffing, or medical intervention, or impairs ability for functional activities of daily living.
- Subjects are expected to exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior.
- Subjects who have a score of ≤16 on the Mini-Mental State Exam (MMSE).
- Subjects with a remote (>5 years) history of stroke may be included, regardless of size/location.
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- Subjects who read, understand, and provide written informed consent, or who have a legally authorized representative (LAR).
- Subjects who are deemed to be medically appropriate for study participation by the principal investigator.
- Subjects who are at their current location for at least 14 days before screening and plan to remain at the same location for the duration of the study.
- Subjects who have the capability to participate in the study and self-administer the investigational product.
- Subjects who are on a stable concomitant medications regimen for the treatment of any concurrent conditions for at least one month prior to the screening visit.
Who cannot join
- Subjects who have dementia associated with Parkinson's disease and/or Lewy Body Disease are excluded.
- Subjects suffering from alcohol and/or substance abuse.
- Subjects with agitation caused by acute intoxication must be excluded.
- Subjects with significant risk of suicide or homicide per the investigator's assessment.
- Subjects who have hydrocephalus, seizure disorder, or history of significant head trauma, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, or focal neurological findings, with a recent (1 year) large (non-microvascular) stroke who may be considered medically unstable or in recovery must be excluded.
- History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years.
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- Subjects with laboratory or ECG abnormalities.
- Subjects with serious, unstable, or uncontrolled medical illnesses must be excluded.
- Subjects who have received an investigational drug within 30 days prior to Screening must be excluded.
- Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving dexmedetomidine must be excluded.
- Subjects whose agitation is attributed to pain or infection, delirium, concomitant medications, environmental conditions, or another psychiatric condition or medical condition as determined by the investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bioxcel Clinical Research Site
North Miami, Florida, 33161
Bioxcel Clinical Research Site
Springfield, Massachusetts, 01103
BioXcel Clinical Research Site
Toms River, New Jersey, 08755
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of BXCL501 For The Treatment of Agitation Associated With Dementia
A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation associated with all forms of dementia (i.e., probably Alzheimer's Disease, vascular dementia; mixed; frontotemporal dementia) excluding Parkinson's-Related Dementia and Lewy Body Dementia.
Read the detailed description
The study will enroll at least 75 subjects to receive a single film consisting of BXCL501 40 μg dose, BXCL501 60 μg dose, or matching placebo film. Subjects must reside in a residential care facility and must require at least moderate assistance with activities of daily living (e.g., bathing, dressing, and toileting). The subject must be able to self-administer the film to participate in the study.
The effects of BXCL 501 on acute agitation will be assessed by the following scales: PEC, PAS, ACES, and CGI-I.
- Being tested
- BXCL501, Placebo film
- 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
Sublingual film containing 40 Micrograms BXCL501
BXCL501Drug
Also called Dexmedetomidine
Sublingual film containing 60 Micrograms BXCL501
Placebo filmDrug
Also called Placebo
Matching Sublingual Placebo film
| Study group | Role | What they receive |
|---|---|---|
| 40 micrograms | Experimental | Sublingual film containing 40 micrograms Dexmedetomidine Receives: Drug: BXCL501 |
| 60 micrograms | Experimental | Sublingual film containing 60 micrograms Dexmedetomidine Receives: Drug: BXCL501 |
| Placebo | Experimental | Sublingual Placebo film Receives: Drug: Placebo film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe).
Measured: 120 minutes
Secondary outcomes (3)
Change From Baseline for Pittsburgh Agitation Scale
The Pittsburgh Agitation Scale (PAS) assesses agitation for individuals with dementia across four behavior groups: aberrant vocalizations, motor agitation, aggressiveness, and resisting care. Each behavior group is scored ranging from 0 (not present) to 4 (maximally present).
Measured: 120 minutes
Change From Baseline for Agitation-Calmness Evaluation Scale
The Agitation-Calmness Evaluation Scale (ACES) is a single item measure rating overall agitation and sedation, where 1 indicates 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
Measured: 120 minutes
Clinical Global Impression - Improvement
The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start8 Feb 2022
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study will randomize subjects 1:1:1 to receive BXCL501 40 μg, BXCL501 60 μg, or matching placebo film
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioXcel Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Responsible party
- Sponsor
- Investigators
- BioXcel MM, MD, Study chair, BioXcel Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276830
- Sponsor's protocol ID
- BXCL501-203
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2022
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 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 BXCL501 For The Treatment of Agitation Associated With Dementia
- ClinicalTrials.gov ID
- NCT05276830
- Acronym / sponsor ID
- BXCL501-203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated for business reasons; not due to safety or efficacy concerns
- Enrolment
- 5 participants (actual)
- Lead sponsor
- BioXcel Therapeutics IncIndustry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Posted 25 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation associated with all forms of dementia (i.e., probably Alzheimer's Disease, vascular dementia; mixed; frontotemporal dementia) excluding Parkinson's-Related Dementia and Lewy Body Dementia.
Detailed description
The study will enroll at least 75 subjects to receive a single film consisting of BXCL501 40 μg dose, BXCL501 60 μg dose, or matching placebo film. Subjects must reside in a residential care facility and must require at least moderate assistance with activities of daily living (e.g., bathing, dressing, and toileting). The subject must be able to self-administer the film to participate in the study.
The effects of BXCL 501 on acute agitation will be assessed by the following scales: PEC, PAS, ACES, and CGI-I.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Study will randomize subjects 1:1:1 to receive BXCL501 40 μg, BXCL501 60 μg, or matching placebo film
| Arm | Type | Receives |
|---|---|---|
| 40 micrograms | Experimental | Drug: BXCL501Sublingual film containing 40 micrograms Dexmedetomidine |
| 60 micrograms | Experimental | Drug: BXCL501Sublingual film containing 60 micrograms Dexmedetomidine |
| Placebo | Experimental | Drug: Placebo filmSublingual Placebo film |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Individuals diagnosed with any form of dementia (i.e., probable Alzheimer's Disease; vascular dementia; mixed; frontotemporal dementia)
- Subjects who have met DSM-5 criteria for dementia (major neurocognitive disorder) who have instances of acute psychomotor agitation.
- History of psychomotor agitation (e.g., kick, bite, flailing) to the point that it impairs social activities, requires staffing, or medical intervention, or impairs ability for functional activities of daily living.
- Subjects are expected to exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior.
- Subjects who have a score of ≤16 on the Mini-Mental State Exam (MMSE).
Key exclusion criteria (11 listed)
- Subjects who have dementia associated with Parkinson's disease and/or Lewy Body Disease are excluded.
- Subjects suffering from alcohol and/or substance abuse.
- Subjects with agitation caused by acute intoxication must be excluded.
- Subjects with significant risk of suicide or homicide per the investigator's assessment.
- Subjects who have hydrocephalus, seizure disorder, or history of significant head trauma, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, or focal neurological findings, with a recent (1 year) large (non-microvascular) stroke who may be considered medically unstable or in recovery must be excluded.
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: DexmedetomidineSublingual film containing 40 Micrograms BXCL501 | Drug | 40 micrograms |
| BXCL501Also: DexmedetomidineSublingual film containing 60 Micrograms BXCL501 | Drug | 60 micrograms |
| Placebo filmAlso: PlaceboMatching Sublingual Placebo film | Drug | Placebo |
Primary outcome
Change in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Time frame: 120 minutes
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe).
3 secondary outcomes
Change From Baseline for Pittsburgh Agitation Scale
Time frame: 120 minutes
Change From Baseline for Agitation-Calmness Evaluation Scale
Time frame: 120 minutes
Clinical Global Impression - Improvement
Time frame: 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
BioXcel MM, MD study chair
BioXcel Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BXCL501 in people with Agitation and Dementia, run by BioXcel Therapeutics Inc at 3 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 11 inclusion and 11 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Aug 2023). 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 in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.