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Alpha-2A Adrenergic Receptor Agonist

40 micrograms for Dementia

Phase 2
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

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.

Eligible Conditions
  • Dementia
  • Agitation

Timeline

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
Change in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
Secondary outcome measures
Change From Baseline for Agitation-Calmness Evaluation Scale
Change From Baseline for Pittsburgh Agitation Scale
Clinical Global Impression - Improvement

Trial Design

3Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Sublingual Placebo film
Group II: 60 microgramsExperimental Treatment1 Intervention
Sublingual film containing 60 micrograms Dexmedetomidine
Group III: 40 microgramsExperimental Treatment1 Intervention
Sublingual film containing 40 micrograms Dexmedetomidine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
FDA approved
Placebo film
2013
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

BioXcel Therapeutics IncLead Sponsor
19 Previous Clinical Trials
2,427 Total Patients Enrolled
3 Trials studying Dementia
264 Patients Enrolled for Dementia
Cognitive Research CorporationIndustry Sponsor
23 Previous Clinical Trials
2,325 Total Patients Enrolled
3 Trials studying Dementia
264 Patients Enrolled for Dementia
Robert Risinger, MDStudy ChairBioXcel Therapeutics
10 Previous Clinical Trials
1,817 Total Patients Enrolled
3 Trials studying Dementia
264 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.
Recent research and studies
clinicaltrials.govStudy
An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia
2022. "An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05276830.
~2 spots leftby Apr 2025
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