Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Agitation,Psychomotor, Dementia

In brief

This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years and older) males and females with acute agitation associated with dementia. Evaluation of 3 doses are planned.

Key facts

Study ID

NCT04251910

Run by

BioXcel Therapeutics Inc

People needed

100

Starts

2019-12-27

Expected to finish

2022-01-24

Last updated by the study team

2026-06-03

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• BioXcel Clinical Research Site — Homestead, Florida, United States
• BioXcel Clinical Research Site — Miami Lakes, Florida, United States
• BioXcel Clinical Research Site — Springfield, Massachusetts, United States
• BioXcel Clinical Research Site — Caro, Michigan, United States
• BioXcel Clinical Research Site — Toms River, New Jersey, United States

Full record on ClinicalTrials.gov

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