Avanir Pharmaceuticals, a biopharmaceutical company, has enrolled its first patient in Phase II study Of AVP-923 for the treatment of agitation in patients with Alzheimer's disease (study AVR-131).
AVP-923 is a combination of the active ingredient dextromethorphan hydrobromide, low dose quinidine sulfate, which serves to increase the bioavailability of dextromethorphan, the ingredient active in the central nervous system, and quinidine sulfate (10mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations.
Cleveland Clinic Neurological Institute neurotherapeutics and drug development professor Dr Jeffrey Cummings said Alzheimer's disease can cause marked behavioural changes that are difficult for caregivers to manage.
"As the disease progresses, behavioural symptoms often increase in frequency and severity. With no approved therapies for agitation associated with dementia, managing these symptoms can be challenging," Cummings said.
"This trial is an important initial step in potentially providing a therapy to help manage symptoms of agitation in Alzheimer's disease."
The proof-of-concept study, which will randomise 200 Alzheimer's patients to receive either AVP-923 or placebo for 10 weeks, is designed to evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of agitation in Alzheimer's patients.
The main efficacy measure of the multicentre, randomised, double-blind, placebo-controlled study is the neuropsychiatric inventory (NPI).
Secondary outcome measures include assessments of disease severity, behavioural abnormalities, cognition, activities of daily living, quality of life and caregiver strain. The study will also conduct standard safety assessments.