AVP-923 is a combination of the active ingredient dextromethorphan hydrobromide and 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 Jeffrey Cummings said Alzheimer’s disease can cause a person to exhibit marked behavioural changes that are difficult for caregivers to manage.
"This trial is an important initial step in potentially providing a therapy to help manage symptoms of agitation in Alzheimer’s disease," Cummings added.
The proof of concept study will randomise 200 Alzheimer’s patients to receive either AVP-923 or placebo for 10 weeks, evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of agitation in Alzheimer’s patients.
The main efficacy measure is the neuropsychiatric inventory while the 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.