← Trials/Trial dossier/NCT04251910

TRANQUILITY

CompletedPhase 1 / PHASE2Results posted

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

A Phase Ib/II, Multicenter, Randomized, Double Blind, Placebo Controlled, Ascending Dose Finding, Efficacy, Pharmacokinetic and Safety Study of BXCL501 In Agitation Associated With Dementia

Lead sponsor

BioXcel Therapeutics Inc

Asset

Dexmedetomidine

Listed sites

Recruiting sites

Enrollment

100

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age ≥65

Primary endpoints

•Positive and Negative Syndrome Scale-Excited Component (PEC) Total Score•Adverse Events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBXCL501-103

NCT IDNCT04251910

Timeline

Milestones

Study start2019-12-27actual

Study first posted2020-02-05actual

Primary completion2022-01-24actual

Study completion2022-01-24actual

Results first posted2023-09-21actual

Last update posted2026-06-03actual

Assets

Drug assets

Dexmedetomidine

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male and female patients 65 years and older.

•Patients who have dementia and a history of acute agitation.

•History of agitation that requires intervention or impairs social or daily activities

•Patients who meet International Psychogeriatric Association (IPA) diagnostic criterion for agitation.

•Patients with a total score of ≥ 8 on the Pittsburgh Agitation Scale (PAS).

•Patients who have a score of ≥ 2 on at least 1 of the 4 items on the Pittsburgh Agitation Scale (PAS).

•Patients who read, understand and provide written informed consent, or who have a Legally Authorized Representative (LAR).

•Patients who are in good general health

Exclusion criteria

•For Part B: Patients with dementia associated with Parkinson's disease and/or Lewy Body Disease, if etiology of dementia is known.

•Patients with agitation caused by acute intoxication.

•Patients treated within 4 hours prior to study drug administration with benzodiazepines, other sedatives, hypnotics or oral or short-acting intramuscular antipsychotics must be excluded.

•Treatment with alpha-1 noradrenergic blockers, alpha adrenergic antagonists within 8 hours prior to dosing.

•No new chronic medications initiated in the past 14 days prior to screening excluding over-the-counter products taken sporadically.

•Patients at significant risk of harm to themselves or others

•Patients considered medically unstable or in recovery

•Patients with history of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension.

•Cohort 3 only: Patients who are taking nitrates or beta blockers shall be excluded. Any other anti-hypertensives should be maintained in the course of the study.

•Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded.

•Patients experiencing clinically significant pain, per Investigator.

•Cohort 3 only: Patients who are a high fall risk assessed via the Johns Hopkins Fall Risk Assessment (total score >13) or during the 1-week safety observation period

•Pregnancy

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Other (unclassified)

Behavior / neuropsychiatric

12 endpoints

Primary/protocol endpoint

Number of Patients With Adverse Events

Time frame:Day 7 post dose

event count, event

Primary/registry result

Number of Patients With Adverse Events

Time frame:Day 7 post dose

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part A-30 mcg BXCL501n=16 Participants	11	-
Part A-60 mcg BXCL501n=20 Participants	14	-
Part A- 90 mcg BXCL501n=4 Participants	4	-
Part A-Placebon=14 Participants	0	-
Part B-40 Mcg-BXCL501n=23 Participants	12	-
Part B-Placebon=23 Participants	2	-

Secondary/protocol endpoint

Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline

Time frame:Baseline and at 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, Day 3, Day 7 post-dose

change from baseline, improvement

Secondary/protocol endpoint

Changes in Agitation-Calmness Evaluation Scale (ACES) Score From Baseline

Time frame:Baseline and 1 hour, 2 hours, 4 hours, 8 hours post-dose

change from baseline, improvement

Secondary/protocol endpoint

Change in Clinician Global Impression of Severity (CGI-S) Agitation Score From Baseline

Time frame:Baseline and at 2 hours, and 24 hours post-dose

change from baseline, improvement

Secondary/protocol endpoint

Clinical Global Impression - Improvement (CGI-I) Agitation Score

Time frame:30 minutes, 1 hour, 2 hours, 4 hours, 8 hours post-dose

change from baseline, improvement

Secondary/protocol endpoint

Change in Cohen Mansfield Agitation Inventory (CMAI) Total Score From Baseline

Time frame:Baseline and at 2 Hours and Day 7 post-dose

change from baseline, improvement

Secondary/registry result

Change in Pittsburgh Agitation Scale (PAS) Total Score From Baseline

Time frame:Baseline and at 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, Day 3, Day 7 post-dose

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Part A-30 mcg BXCL50130 minutesn=16 Participants	-1.3	1.2
1 hourn=16 Participants	-2.5	1.8
2 hoursn=16 Participants	-3.9	2.4
4 hoursn=16 Participants	-4.7	3.1
8 hoursn=16 Participants	-4.4	3.2
24 hoursn=16 Participants	-4.3	2.8
Day 3n=16 Participants	-3.9	3.4
Day 7n=16 Participants	-3.9	3.1
Part A-60 mcg BXCL50130 minutesn=20 Participants	-1.6	1.7
1 hourn=20 Participants	-4.0	2.2
2 hoursn=20 Participants	-5.8	2.1
4 hoursn=20 Participants	-6.4	1.3
8 hoursn=20 Participants	-6.2	1.7
24 hoursn=20 Participants	-4.9	2.1
Day 3n=20 Participants	-4.9	2.4
Day 7n=20 Participants	-4.3	2.3
Part A-Placebo30 minutesn=14 Participants	-1.3	1.6
1 hourn=14 Participants	-2.1	1.8
2 hoursn=14 Participants	-2.6	2.4
4 hoursn=14 Participants	-3.3	2.8
8 hoursn=14 Participants	-3.1	2.0
24 hoursn=14 Participants	-3.9	2.4
Day 3n=14 Participants	-3.7	3.4
Day 7n=14 Participants	-3.3	2.7
Part B-40 Mcg-BXCL50130 minutesn=23 Participants	-1.3	2.8
1 hourn=23 Participants	-4.7	3.2
2 hoursn=23 Participants	-5.4	3.4
4 hoursn=23 Participants	-5.2	3.7
8 hoursn=23 Participants	-4.1	3.5
24 hoursn=23 Participants	-2.0	2.2
Day 3n=23 Participants	-2.0	1.9
Day 7n=23 Participants	-2.6	3.3
Part B-Placebo30 minutesn=23 Participants	-0.7	0.9
1 hourn=23 Participants	-1.6	2.0
2 hoursn=23 Participants	-1.8	2.7
4 hoursn=23 Participants	-2.1	2.8
8 hoursn=23 Participants	-2.3	2.7
24 hoursn=23 Participants	-1.8	2.4
Day 3n=23 Participants	-1.9	1.6
Day 7n=23 Participants	-1.1	1.4

p0.9616Mixed effects model

Part A 30 mcg BXCL501 v/s Part A-Placebo (30 minutes)

p0.5460Mixed effects model

Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)

p0.0961Mixed effects model

Part A-30 mcg BXCL501 V/s Part A-Placebo (2 hours)

p0.1359Mixed effects model

Part A-30 mcg BXCL501 v/s Part A-Placebo (4 hours)

p0.1688Mixed effects model

Part A-30 mcg BXCL501 v/s Part A-Placebo (8 hours)

p0.6670Mixed effects model

Part A-30 mcg BXCL501 v/s Part A-Placebo (24 hours)

p0.8695Mixed effects model

Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 3)

p0.5002Mixed effects model

Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 7)

p0.5631Mixed effects model

Part A-60 mcg BXCL501 v/s Part A-Placebo (30 minutes)

p0.0089Mixed effects model

Part A-60 mcg BXCL501 v/s Part A-Placebo (1 hour)

p<.0001Mixed effects model

Part A-60 mcg BXCL501 v/s Part A-Placebo (2 hours)

p0.0011Mixed effects model

Part A-60 mcg BXCL501 v/s Part A-Placebo (4 hours)

p0.0008Mixed effects model

Part A-60 mcg BXCL501 v/s Part A-Placebo (8 hours)

p0.2847Mixed effects model

Part A-60 mcg BXCL501 v/s Part A-Placebo (24 hours)

p0.2616Mixed effects model

Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 3)

p0.1989Mixed effects model

Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 7)

p0.4585Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (30 minutes)

p0.0005Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (1 hour)

p0.0004Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)

p0.0025Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (4 hours)

p0.1027Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (8 hours)

p0.7953Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (24 hours)

p0.1416Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)

p0.0658Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)

Secondary/registry result

Changes in Agitation-Calmness Evaluation Scale (ACES) Score From Baseline

Time frame:Baseline and 1 hour, 2 hours, 4 hours, 8 hours post-dose

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Part A-30 mcg BXCL5011 hourn=16 Participants	0.6	0.6
2 hoursn=16 Participants	0.9	1.0
4 hoursn=16 Participants	1.3	1.0
8 hoursn=16 Participants	1.4	1.1
Part A-60 mcg BXCL5011 hourn=20 Participants	1.1	0.7
2 hoursn=20 Participants	2.7	1.6
4 hoursn=20 Participants	2.7	1.2
8 hoursn=20 Participants	2.2	0.9
Part A-Placebo1 hourn=14 Participants	0.5	0.5
2 hoursn=14 Participants	0.9	0.9
4 hoursn=14 Participants	0.9	1.1
8 hoursn=14 Participants	0.9	0.8
Part B-40 Mcg-BXCL5011 hourn=23 Participants	1.8	1.6
2 hoursn=23 Participants	2.5	1.9
4 hoursn=23 Participants	2.4	2.0
8 hoursn=22 Participants	1.5	1.5
Part B-Placebo1 hourn=23 Participants	0.4	0.8
2 hoursn=23 Participants	0.7	1.3
4 hoursn=23 Participants	1.0	1.4
8 hoursn=23 Participants	1.0	1.2

p0.8760Mixed effects model

Part A -30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)

p0.9077Mixed effects model

Part A 30 mcg BXCL501 v/s Part A-Placebo (Day 1; 2 hours)

p0.7208Mixed effects model

Part A 30 mcg BXCL501 vs Part A-Placebo (Day1; 4 hours)

p0.3666Mixed effects model

Part A BXCL501 30 mcg v/s Part A-Placebo(Day 1;8 hours)

p0.0191Mixed effects model

Part A BXCL501 60 mcg v/s Placebo-Part A (Day1; 1 hour)

p0.0006Mixed effects model

Part A BXCL501 60 mcg v/s Part A-Placebo (Day 1; 2 hours)

p<.0001Mixed effects model

Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 1; 4 hours)

p0.0003Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1;8 hours)

p0.0006Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)

p0.0002Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)

p0.0029Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)

p0.2446Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)

Secondary/registry result

Change in Clinician Global Impression of Severity (CGI-S) Agitation Score From Baseline

Time frame:Baseline and at 2 hours, and 24 hours post-dose

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Part A-30 mcg BXCL5012 hoursn=16 Participants	-1.3	0.8
24 hoursn=16 Participants	-1.4	1.1
Part A-60 mcg BXCL5012 hoursn=20 Participants	-2.1	0.9
24 hoursn=20 Participants	-1.6	0.9
Part A-Placebo2 hoursn=14 Participants	-0.9	0.9
24 hoursn=14 Participants	-1.2	1.1
Part B-40 Mcg-BXCL5012 hoursn=23 Participants	-2.2	1.3
24 hoursn=23 Participants	-1.2	1.1
Part B-Placebo2 hoursn=23 Participants	-0.7	1.0
24 hoursn=23 Participants	-0.7	1.2

p0.0952Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)

p0.8977Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)

p0.0002Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)

p0.3147Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)

p<.0001Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)

p0.1241Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)

Secondary/registry result

Clinical Global Impression - Improvement (CGI-I) Agitation Score

Time frame:30 minutes, 1 hour, 2 hours, 4 hours, 8 hours post-dose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Part A-30 mcg BXCL50130 minutesn=16 Participants	3.3	0.2
1 hourn=16 Participants	3.0	0.2
2 hoursn=16 Participants	2.4	0.2
4 hoursn=16 Participants	2.4	0.3
8 hoursn=16 Participants	2.3	0.2
Part A-60 mcg BXCL50130 minutesn=20 Participants	3.4	0.2
1 hourn=20 Participants	2.6	0.2
2 hoursn=20 Participants	1.6	0.2
4 hoursn=20 Participants	1.5	0.2
8 hoursn=20 Participants	1.4	0.2
Part A-Placebo30 minutesn=14 Participants	3.5	0.2
1 hourn=14 Participants	3.3	0.2
2 hoursn=14 Participants	3.2	0.2
4 hoursn=14 Participants	3.0	0.3
8 hoursn=14 Participants	3.0	0.2
Part B-40 Mcg-BXCL50130 minutesn=23 Participants	3.5	0.1
1 hourn=23 Participants	2.5	0.2
2 hoursn=23 Participants	1.9	0.2
4 hoursn=23 Participants	2.0	0.3
8 hoursn=22 Participants	2.5	0.3
Part B-Placebo30 minutesn=23 Participants	3.7	0.1
1 hourn=23 Participants	3.5	0.2
2 hoursn=23 Participants	3.6	0.2
4 hoursn=23 Participants	3.3	0.3
8 hoursn=23 Participants	3.5	0.3

p0.4080Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)

p0.4198Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)

p0.0370Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day1; 2 hours)

p0.1324Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)

p0.0624Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)

p0.6334Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)

p0.0275Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)

p<.0001Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)

p0.0001Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)

p<.0001Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day1; 8 hours)

p0.2806Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)

p0.0002Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)

p<.0001Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hour)

p0.0009Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)

p0.0081Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)

Secondary/registry result

Change in Cohen Mansfield Agitation Inventory (CMAI) Total Score From Baseline

Time frame:Baseline and at 2 Hours and Day 7 post-dose

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Part A-30 mcg BXCL5012 hoursn=16 Participants	-8.9	5.1
Day 7n=16 Participants	-5.9	4.3
Part A-60 mcg BXCL5012 hoursn=20 Participants	-14.7	9.8
Day 7n=20 Participants	-6.6	6.7
Part A-Placebo2 hoursn=14 Participants	1.6	4.5
Day 7n=14 Participants	0.4	9.8
Part B-40 Mcg-BXCL5012 hoursn=23 Participants	-17.9	22.7
Day 7n=23 Participants	-6.9	17.7
Part B-Placebo2 hoursn=23 Participants	-5.7	14.0
Day 7n=23 Participants	-1.4	4.5

p0.0591Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)

p0.0966Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)

p<.0001Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)

p0.0290Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)

p0.0937Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)

p0.2747Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)

Other (unclassified)

12 endpoints

Primary/protocol endpoint/low confidence

Mean Change From Baseline in Positive and Negative Syndrome Scale-Excited Component (PEC) Total Score

Time frame:Baseline and 2 hours post-dose

change from baseline, improvement

Primary/registry result/low confidence

Mean Change From Baseline in Positive and Negative Syndrome Scale-Excited Component (PEC) Total Score

Time frame:Baseline and 2 hours post-dose

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Part A-30 mcg BXCL501n=16 Participants	-5.4	3.4
Part A-60 mcg BXCL501n=20 Participants	-7.1	3.8
Part A-Placebon=14 Participants	-2.9	2.7
Part B-40 Mcg-BXCL501n=23 Participants	-6.8	5.1
Part B-Placebon=23 Participants	-1.8	4.4

p0.0813Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)

p0.0011Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours)

p0.0002Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)

Secondary/protocol endpoint/low confidence

Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline

Time frame:Baseline and at 30 minutes, 1 hour, 4 hours, 8 hours, 24 hours, Day 3 and Day 7 post-dose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Patients at Each Dose Who Achieve a 40% Reduction From Baseline in PEC Total Score at 2 Hours Post-dose ("Responders")

Time frame:Baseline and 2 hours post-dose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Patients With Event "Time Taken for Medication to Dissolve"

Time frame:At 30 minutes post-dose

event count, event

Secondary/protocol endpoint/low confidence

Number of Patients Showing Negative Reaction to Sublingual Film in the Examiner's Opinion

Time frame:At 30 minutes, 2 hours, 4 hours, 24 hours post dose

event count, event

Secondary/protocol endpoint/low confidence

Part B: Change From Baseline in the Total Score of 3 Supplementary Items of Positive and Negative Syndrome Scale (PANSS)

Time frame:Baseline and at 2 hours post-dose

change from baseline, improvement

Secondary/registry result/low confidence

Changes in Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) Total Score From Baseline

Time frame:Baseline and at 30 minutes, 1 hour, 4 hours, 8 hours, 24 hours, Day 3 and Day 7 post-dose

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Part A-30 mcg BXCL50130 minutesn=16 Participants	-2.2	1.6
1 hoursn=16 Participants	-3.6	1.9
4 hoursn=16 Participants	-6.8	4.4
8 hoursn=16 Participants	-7.1	4.6
Day 2; 24 hoursn=16 Participants	-5.7	4.0
Day 3n=16 Participants	-5.3	5.0
Day 7n=16 Participants	-4.9	3.9
Part A-60 mcg BXCL50130 minutesn=20 Participants	-1.7	2.2
1 hoursn=20 Participants	-5.4	3.6
4 hoursn=20 Participants	-8.1	2.5
8 hoursn=20 Participants	-8.8	3.1
Day 2; 24 hoursn=20 Participants	-6.0	3.8
Day 3n=20 Participants	-5.9	4.2
Day 7n=20 Participants	-4.6	3.9
Part A-Placebo30 minutesn=14 Participants	-0.6	1.4
1 hoursn=14 Participants	-2.3	2.0
4 hoursn=14 Participants	-4.1	3.6
8 hoursn=14 Participants	-4.6	3.3
Day 2; 24 hoursn=14 Participants	-4.3	3.3
Day 3n=14 Participants	-3.9	3.7
Day 7n=14 Participants	-3.4	4.4
Part B-40 Mcg-BXCL50130 minutesn=23 Participants	-1.0	2.4
1 hoursn=23 Participants	-5.7	4.4
4 hoursn=23 Participants	-6.5	4.5
8 hoursn=22 Participants	-5.0	4.3
Day 2; 24 hoursn=23 Participants	-3.4	3.7
Day 3n=22 Participants	-3.2	3.3
Day 7n=22 Participants	-2.5	4.1
Part B-Placebo30 minutesn=23 Participants	-1.0	1.7
1 hoursn=23 Participants	-1.9	3.2
4 hoursn=23 Participants	-2.8	4.8
8 hoursn=23 Participants	-3.2	4.7
Day 2; 24 hoursn=23 Participants	-2.4	4.0
Day 3n=23 Participants	-1.8	2.7
Day 7n=23 Participants	-1.5	1.5

p0.0926Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)

p0.3976Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)

p0.1169Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)

p0.3786Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)

p0.5640Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24hours)

p0.6020Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 3)

p0.5875Mixed effects model

Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)

p0.1055Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)

p0.0024Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)

p0.0016Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)

p0.0002Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)

p0.2039Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)

p0.1948Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 3)

p0.5615Mixed effects model

Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)

p0.8266Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)

p0.0002Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)

p0.0004Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)

p0.1037Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)

p0.3267Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)

p0.0339Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)

p0.1892Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day7)

Secondary/registry result/low confidence

Number of Patients at Each Dose Who Achieve a 40% Reduction From Baseline in PEC Total Score at 2 Hours Post-dose ("Responders")

Time frame:Baseline and 2 hours post-dose

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part A-30 mcg BXCL501n=16 Participants	4	-
Part A-60 mcg BXCL501n=20 Participants	14	-
Part A-Placebon=14 Participants	1	-
Part B-40 Mcg-BXCL501n=23 Participants	9	-
Part B-Placebon=23 Participants	2	-

p0.3359Fisher Exact

Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)

p0.0004Fisher Exact

Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)

p0.0351Fisher Exact

Secondary/registry result/low confidence

Number of Patients With Event "Time Taken for Medication to Dissolve"

Time frame:At 30 minutes post-dose

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part A-30 mcg BXCL5011- 30 secondsn=16 Participants	0	-
31- 59 secondsn=16 Participants	0	-
1- 2 minutesn=16 Participants	10	-
3+ minutesn=16 Participants	6	-
Part A-60 mcg BXCL5011- 30 secondsn=20 Participants	0	-
31- 59 secondsn=20 Participants	0	-
1- 2 minutesn=20 Participants	8	-
3+ minutesn=20 Participants	12	-
Part A- 90 mcg BXCL5011- 30 secondsn=4 Participants	0	-
31- 59 secondsn=4 Participants	0	-
1- 2 minutesn=4 Participants	2	-
3+ minutesn=4 Participants	2	-
Part A-Placebo1- 30 secondsn=14 Participants	0	-
31- 59 secondsn=14 Participants	0	-
1- 2 minutesn=14 Participants	8	-
3+ minutesn=14 Participants	6	-
Part B-40 Mcg-BXCL5011- 30 secondsn=23 Participants	0	-
31- 59 secondsn=23 Participants	0	-
1- 2 minutesn=23 Participants	12	-
3+ minutesn=23 Participants	11	-
Part B-Placebo1- 30 secondsn=23 Participants	0	-
31- 59 secondsn=23 Participants	2	-
1- 2 minutesn=23 Participants	10	-
3+ minutesn=23 Participants	11	-

Secondary/registry result/low confidence

Number of Patients Showing Negative Reaction to Sublingual Film in the Examiner's Opinion

Time frame:At 30 minutes, 2 hours, 4 hours, 24 hours post dose

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Part A-30 mcg BXCL50130 minutes Post dosen=16 Participants	0	-
2 hours post dosen=16 Participants	0	-
4 hours post dosen=16 Participants	0	-
24 hours post dosen=16 Participants	0	-
Part A-60 mcg BXCL50130 minutes Post dosen=20 Participants	0	-
2 hours post dosen=20 Participants	0	-
4 hours post dosen=20 Participants	0	-
24 hours post dosen=20 Participants	0	-
Part A- 90 mcg BXCL50130 minutes Post dosen=4 Participants	0	-
2 hours post dosen=4 Participants	0	-
4 hours post dosen=4 Participants	0	-
24 hours post dosen=4 Participants	0	-
Part A-Placebo30 minutes Post dosen=14 Participants	0	-
2 hours post dosen=14 Participants	0	-
4 hours post dosen=14 Participants	0	-
24 hours post dosen=14 Participants	0	-
Part B-40 Mcg-BXCL50130 minutes Post dosen=23 Participants	0	-
2 hours post dosen=23 Participants	0	-
4 hours post dosen=23 Participants	0	-
24 hours post dosen=23 Participants	0	-
Part B-Placebo30 minutes Post dosen=23 Participants	0	-
2 hours post dosen=23 Participants	0	-
4 hours post dosen=23 Participants	0	-
24 hours post dosen=23 Participants	0	-

Secondary/registry result/low confidence

Part B: Change From Baseline in the Total Score of 3 Supplementary Items of Positive and Negative Syndrome Scale (PANSS)

Time frame:Baseline and at 2 hours post-dose

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Part B-40 Mcg-BXCL501n=23 Participants	-3.7	2.9
Part B-Placebon=22 Participants	-0.6	2.3

p0.0002Mixed effects model

Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours post administration)

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Persson NDA, Uusalo P, Nedergaard M, Lohela TJ, Lilius TO. Could dexmedetomidine be repurposed as a glymphatic enhancer? Trends Pharmacol Sci. 2022 Dec;43(12):1030-1040. doi: 10.1016/j.tips.2022.09.007. Epub 2022 Oct 21.
PMID36280451via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.