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Alpha-2 Adrenergic Agonist

Dexmedetomidine 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
Episodes of psychomotor agitation (e.g., kick, bite, flailing)
Subjects exhibit behaviors congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes post-dose for first episode of agitation
Awards & highlights

Study Summary

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

Eligible Conditions
  • Agitation
  • Dementia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have episodes of restlessness and uncontrolled movements.
Select...
The person shows signs of agitation that are different from their usual behavior, as defined by a specific association.
Select...
You have severe difficulties with memory and need a lot of help with everyday tasks.
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You must have been diagnosed with probable Alzheimer's disease according to specific medical criteria from either 2018 or 2011.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes post-dose for first episode of agitation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes post-dose for first episode of agitation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

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

Find a Location

Who is running the clinical trial?

BioXcel Therapeutics IncLead Sponsor
18 Previous Clinical Trials
2,409 Total Patients Enrolled
3 Trials studying Dementia
256 Patients Enrolled for Dementia
Cognitive Research CorporationIndustry Sponsor
23 Previous Clinical Trials
2,317 Total Patients Enrolled
3 Trials studying Dementia
256 Patients Enrolled for Dementia
Robert Risinger, MDStudy ChairBioXcel Therapeutics
10 Previous Clinical Trials
1,809 Total Patients Enrolled
3 Trials studying Dementia
256 Patients Enrolled for Dementia

Media Library

Dexmedetomidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05665088 — Phase 3
Dementia Research Study Groups: Cohort 1- 40 Micrograms, Cohort 2- 60 Micrograms, Placebo
Dementia Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT05665088 — Phase 3
Dexmedetomidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05665088 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~6 spots leftby Mar 2025