Cohort 1- 40 Micrograms for Dementia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
BioXcel Clinical Research Site, Springfield, MADementia+1 MoreBXCL501 - Drug
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a drug for treating agitation in people with dementia, up to 168 doses in 12 weeks.

Eligible Conditions
  • Dementia
  • Agitation

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

0 Primary · 1 Secondary · Reporting Duration: 30 minutes post-dose for first episode of agitation

30 minutes post-dose for first episode of agitation
Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score

Trial Safety

Safety Progress

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

Side Effects for

Dexmedetomidine
57%Clinically important hypotension
9%Clinically important bradycardia
1%stroke
1%Atelectasis
1%infection
1%Hemorrhage
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02004613) in the Dexmedetomidine ARM group. Side effects include: Clinically important hypotension with 57%, Clinically important bradycardia with 9%, stroke with 1%, Atelectasis with 1%, infection with 1%.

Trial Design

3 Treatment Groups

Cohort 1- 40 Micrograms
1 of 3
Cohort 2- 60 Micrograms
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

150 Total Participants · 3 Treatment Groups

Primary Treatment: Cohort 1- 40 Micrograms · Has Placebo Group · Phase 3

Cohort 1- 40 Micrograms
Drug
Experimental Group · 1 Intervention: BXCL501 · Intervention Types: Drug
Cohort 2- 60 Micrograms
Drug
Experimental Group · 1 Intervention: BXCL501 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Matching Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 minutes post-dose for first episode of agitation

Who is running the clinical trial?

BioXcel Therapeutics IncLead Sponsor
16 Previous Clinical Trials
2,397 Total Patients Enrolled
3 Trials studying Dementia
255 Patients Enrolled for Dementia
Cognitive Research CorporationIndustry Sponsor
21 Previous Clinical Trials
2,151 Total Patients Enrolled
3 Trials studying Dementia
255 Patients Enrolled for Dementia
Robert Risinger, MDStudy ChairBioXcel Therapeutics
7 Previous Clinical Trials
1,183 Total Patients Enrolled
3 Trials studying Dementia
255 Patients Enrolled for Dementia

Eligibility Criteria

Age 65+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of aggressive behavior such as kicking, biting or flailing.
You show signs of agitation that are different from your normal behavior, based on a standard set by the International Psychogeriatric Association.

Frequently Asked Questions

What hazards are associated with a Cohort 1- 40 Micrograms protocol?

"Based on the available research, Cohort 1- 40 Micrograms received a score of 3 in terms of safety. This is due to Phase 3 trials that have been conducted with positive results both in efficacy and overall risk assessment." - Anonymous Online Contributor

Unverified Answer

Are there still available opportunities to participate in this research?

"As indicated on clinicaltrials.gov, the recruitment for this medical trial is still ongoing; it was initially posted on December 14th 2022 and recently updated on December 16th 2022." - Anonymous Online Contributor

Unverified Answer

What is the maximum capacity of participants for this trial?

"Correct. The clinicaltrials.gov database implies that this experiment is accepting patients, with the original posting dating back to December 14th 2022 and last updated on December 16th 2022. This research requires 150 individuals to be recruited at one study site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.