AVP-786 for the Treatment of Agitation in Dementia of the Alzheimer's Type

Summary

This study focuses on individuals who have been diagnosed with probable Alzheimer’s disease (AD) and have agitation. Agitated behaviors such as irritability and restlessness, physical/verbal aggression, pacing and wandering are major problems in Alzheimer’s patients. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of an investigational drug called AVP-786 for the treatment of agitation in participants with dementia of the Alzheimer’s type. AVP-786 is a combination product of deudextromethorphan hydrobromide, a central nervous system-active agent, and quinidine sulfate. Participants will be randomly assigned to receive either AVP-786 or placebo.


Inclusion Criteria

  • Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
  • Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
  • Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
  • Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer?s type

Details
Disease Type/Condition

Alzheimer's disease

Principal Investigator

Kremen, Sarah

Co-Investigators

Zaldy Tan

Age Group

Adult

Phase

III

IRB Number

STUDY00001610

ClinicalTrials.gov ID

NCT04408755

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Alzheimer's disease

Principal Investigator

Kremen, Sarah

Age Group

Adult

Phase

III

IRB Number

20-AVP-786-307

ClinicalTrials.gov ID

NCT04408755

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?