A Study of BNC210 in Elderly Patients With Agitation

• Status: Completed
• Trial end date: 2019-04-24
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II randomised, double-blind, placebo-controlled study assessing the effects of BNC210 on agitation in hospitalised elderly patients as measured by the Pittsburgh Agitation Scale (PAS). Safety and tolerability of BNC210 will also be assessed.

The secondary objectives of the study include evaluation of the effects of BNC210 on global function in patients with agitation as assessed by the Clinical Global Impression Scale (CGI-S/I).

Participants will receive 5 days of blinded treatment followed by 2 days of follow up.

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

Details

• Lead Sponsor: Bionomics Limited

Criteria

Key Inclusion Criteria:

• Male or female elderly patient admitted to hospital and under the care of a specialist Geriatrician

• Determined to have agitation requiring intervention in addition to standard of care behavioural management, as assessed by the Investigator or delegate, after at least 24 hours following admission to hospital.

Key Exclusion Criteria:

• Severe Alzheimer's Dementia (stage 7) as assessed by the Functional Assessment Staging Test (FAST).

• Diagnosed with Severe Parkinson's Disease.

• Premorbid psychotic illness as assessed by the Investigator.

• Evidence of severe organ dysfunction

• Confirmed metastatic malignancy.