Conditions: Agitation Alzheimer's Disease
Keywords: AVP-923-20 AVP-923-30 AVP-923 Dextromethorphan Quinidine Neuropsychiatric Inventory Aggression Efficacy Safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 220
Healthy volunteers: no

Brief summary:
The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).

Detailed description:
Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.

This is a multicenter, randomized, double-dummy, double-blind, placebo-controlled study, consisting of 10 weeks of treatment.

Up to 200 participants will be enrolled at approximately 30-40 centers in the US.

Study medication will be administered orally twice-daily from Day 1 through Day 70. Screening must occur within within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Arms:
arm 1: Participants will receive placebo during Stage 1 and Stage 2 of the study. arm 2: Participants will receive AVP-923-20 and AVP-923-30 in a sequential manner during Stage 1 and Stage 2 of the study. arm 3: Participants will receive placebo in Stage 1 followed by AVP-923 in Stage 2.

Interventions: intervention 1: AVP-923-20 intervention 2: Placebo intervention 3: AVP-923-30
Intervention descriptions: intervention 1: AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine intervention 2: Placebo capsule intervention 3: AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine

Protocol document: