An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia (NCT05276830) | Clinical Trial Compass
TerminatedPhase 2
An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia
Stopped: Study was terminated for business reasons; not due to safety or efficacy concerns
United States5 participantsStarted 2022-02-08
Plain-language 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; mixed; frontotemporal dementia) excluding Parkinson's-Related Dementia and Lewy Body Dementia.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
. 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.
Exclusion criteria
. 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.
. Subjects with laboratory or ECG abnormalities.
. Subjects with serious, unstable, or uncontrolled medical illnesses must be excluded.