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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

NCT04464564 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2025-05-30

Study results available
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Summary

This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

Conditions

  • Agitation in Patients With Dementia of the Alzheimer's Type

Interventions

DRUG

AVP-786

oral capsules

DRUG

Placebo

oral capsules

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2024-06-28
Completion
2024-06-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Hungary
  • Ireland
  • Mexico
  • Netherlands
  • Slovakia
  • Slovenia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04464564 on ClinicalTrials.gov