← Back to Search

Alpha-2 Agonist

BXCL501 for Dementia

Phase 3

Waitlist Available

Research Sponsored by BioXcel Therapeutics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes

Awards & highlights

Study Summary

This trial will test a new drug to see if it works and is safe for treating agitation caused by dementia. Up to 28 doses will be given over 12 weeks.

Eligible Conditions

Agitation
Dementia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score

Secondary outcome measures

Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for all episodes of agitation

Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for the first episode of agitation

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2- 60 MicrogramsExperimental Treatment1 Intervention

Sublingual film containing 60 Micrograms Dexmedetomidine

Group II: Cohort 1- 40 MicrogramsExperimental Treatment1 Intervention

Sublingual film containing 40 Micrograms Dexmedetomidine

Group III: PlaceboPlacebo Group1 Intervention

Sublingual Placebo film

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BXCL501

2022

Completed Phase 3

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BioXcel Therapeutics IncLead Sponsor

19 Previous Clinical Trials

2,281 Total Patients Enrolled

3 Trials studying Dementia

118 Patients Enrolled for Dementia

Cognitive Research CorporationIndustry Sponsor

23 Previous Clinical Trials

2,179 Total Patients Enrolled

3 Trials studying Dementia

118 Patients Enrolled for Dementia

Robert Risinger, MDStudy ChairBioXcel Therapeutics

10 Previous Clinical Trials

1,671 Total Patients Enrolled

3 Trials studying Dementia

118 Patients Enrolled for Dementia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still enrolling people in this research project?

"This trial, which was originally advertised on 4/27/2022, is still recruiting patients according to the latest information found on clinicaltrials.gov. The listing was most recently edited on 11/16/2022."

Answered by AI

How many individuals are being treated in this study?

"That is accurate. The clinicaltrials.gov website has information showing that this study began recruiting on 4/27/2022 and is still looking for patients. So far, 10 sites have enrolled 150 people in total."

Answered by AI

What are the odds of negative side effects from BXCL501?

"BXCL501 has received a score of 3 from our team at Power. This is due to the fact that BXCL501 is in Phase 3 trials, meaning that there is data supporting both efficacy and safety."

Answered by AI

Where are the different locations participating in this research project?

"There are 10 different sites where this trial is taking place. The locations include Lady Lake, Miami Lakes and North Miami as well as other places. If you decide to participate in this trial, it would be best to choose the location nearest to you so that travel isn't too demanding."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05271552.