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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
Be older than 65 years old
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes post-dose for first episode of agitation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes post-dose for first episode of agitation
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 • NCT0200461357%
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
19 Previous Clinical Trials
2,342 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
1,812 Total Patients Enrolled
3 Trials studying Dementia
256 Patients Enrolled for Dementia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have episodes of restlessness and uncontrolled movements.You have memory problems that are not caused by Alzheimer's disease.You have abnormal lab test results or ECG readings.You are currently using drugs or alcohol excessively.You have experienced recent agitation and confusion that may be related to a medical condition.You must have been diagnosed with probable Alzheimer's disease according to specific medical criteria from either 2018 or 2011.If there is evidence that a stroke is linked to the decline in thinking and memory, a person may not be included in the study for probable Alzheimer's disease.The doctor thinks you might be at risk of hurting yourself or someone else.You are currently not in good health or are recovering from a medical condition. If you had a stroke over 5 years ago, you might still be able to participate.You are currently agitated due to being intoxicated.The person shows signs of agitation that are different from their usual behavior, as defined by a specific association.You have severe difficulties with memory and need a lot of help with everyday tasks.You have had fainting episodes or low blood pressure in the past 2 years, or you currently have low blood volume or low heart rate.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1- 40 Micrograms
- Group 2: Cohort 2- 60 Micrograms
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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