Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioXcel Therapeutics Inc
• Collaborator: Cognitive Research Corporation
• Treatments: Dexmedetomidine

Criteria

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