BXCL501 for Dementia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Dementia+2 More
BXCL501 - Drug
Eligibility
65+
All Sexes
What conditions do you have?
Select

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
  • Dementia
  • Agitation

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 120 minutes

120 minutes
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for all episodes of agitation
Primary End Point
30 minutes
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for the first episode of agitation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Cohort 2- 60 Micrograms
1 of 3
Cohort 1- 40 Micrograms
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

150 Total Participants · 3 Treatment Groups

Primary Treatment: BXCL501 · Has Placebo Group · Phase 3

Cohort 2- 60 MicrogramsExperimental Group · 2 Interventions: BXCL501, Dexmedetomidine (BXCL501) · Intervention Types: Drug, Drug
Cohort 1- 40 MicrogramsExperimental Group · 2 Interventions: BXCL501, Dexmedetomidine (BXCL501) · Intervention Types: Drug, Drug
PlaceboPlaceboComparator Group · 2 Interventions: Matching Placebo, Placebo · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 120 minutes

Who is running the clinical trial?

Cognitive Research CorporationIndustry Sponsor
20 Previous Clinical Trials
2,001 Total Patients Enrolled
2 Trials studying Dementia
105 Patients Enrolled for Dementia
BioXcel Therapeutics IncLead Sponsor
13 Previous Clinical Trials
1,532 Total Patients Enrolled
2 Trials studying Dementia
105 Patients Enrolled for Dementia
Robert Risinger, MDStudy ChairBioXcel Therapeutics
5 Previous Clinical Trials
583 Total Patients Enrolled
2 Trials studying Dementia
105 Patients Enrolled for Dementia

Eligibility Criteria

Age 65+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have probable AD based on NIA-AA criteria (2018).
You have had at least one episode of psychomotor agitation in the past two weeks.
You have a score of 15 to 23 on the Mini-Mental State Exam (MMSE).
You are of reproductive age and you agree to use a medically acceptable and effective birth control method.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.