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

BXCL501-103

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.

2019-12-27

2022-01-24

2022-01-24

Completed

Early phase I

100

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

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2023-09-21