CompletedPhase 3

A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

United States259 participantsStarted 2018-10-11

Plain-language summary

Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).

Who can participate

Age range55 Years – 91 Years

SexALL

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Inclusion Criteria: * Participants must have participated in the 331-14-213 study. * Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior. Exclusion Criteria: * Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

What they're measuring

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity

Timeframe: From first dose through 30 days after last dose of study drug (Up to approximately Week 16)

Trial details

NCT IDNCT03594123

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-19

Results submitted2023-09-18

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