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Assessment of the Efficacy Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Assessment of the Efficacy Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Recruiting
50-90 years
All
Phase 3

Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.

This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment.

Approximately 750 participants will be enrolled at approximately 110 centers worldwide.

Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur 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.

Study details
    Agitation in Patients With Dementia of the Alzheimer's Type

NCT04408755

Avanir Pharmaceuticals

19 February 2024

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